http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSub
missions/DataStandardsManualmonographs/ucm071666.htm
FDA Revised Date.
CDER Revised Dates. January 12, 1993; October 11, 1994; January 10, 1995; December 12, 1996;
November 8, 1996; April 21, 1997; November 14, 1997; February 24, 1998; November 2, 1998;
December 21, 2000; June 6, 2002; April 12, 2005; January 11, 2006; April 20, 2006; May 13; 2006; June
21, 2006; September 27, 2006; December 15, 2006
Data Values.
USE
NAME
DEFINITION
RESTRICTI
ONS
AEROSOL
A product that is
SHORT
NAME
FDA
NCI
COD
CONCEPT
E
ID
a,b,c
AER
246
C42887
a,b,c
AER FOAM
800
C42888
packaged under pressure
and contains
therapeutically active
ingredients that are
released upon activation
of an appropriate valve
system; it is intended for
topical application to the
skin as well as local
application into the nose
(nasal aerosols), mouth
(lingual aerosols), or
lungs (inhalation
aerosols).
AEROSOL,
A dosage form
FOAM
containing one or more
active ingredients,
surfactants, aqueous or
nonaqueous liquids, and
the propellants; if the
propellant is in the
internal (discontinuous)
phase (i.e., of the
oil-in-water type), a
stable foam is
discharged, and if the
propellant is in the
external (continuous)
phase (i.e., of the
water-in-oil type), a
spray or a quick-breaking
foam is discharged.
AEROSOL,
A pressurized dosage
METERED
form consisting of
a,b,c
AER MET
339
C42960
a,b
AER PWD
801
C42971
a,b
AER
247
C42889
metered dose valves
which allow for the
delivery of a uniform
quantity of spray upon
each activation.
AEROSOL,
A product that is
POWDER
packaged under pressure
and contains
therapeutically active
ingredients, in the form
of a powder, that are
released upon activation
of an appropriate valve
system.
AEROSOL,
An aerosol product
SPRAY
which utilizes a
compressed gas as the
propellant to provide the
SPRAY
force necessary to expel
the product as a wet
spray; it is applicable to
solutions of medicinal
agents in aqueous
solvents.
BAR,
A solid dosage form
CHEWABLE
usually in the form of a
a,b,c
BAR CHEW
347
C42892
a,b
BEAD
317
C42890
802
C43451
rectangle that is meant to
be chewed.
BEAD
A solid dosage form in
the shape of a small ball.
BEAD,
A small sterile solid mass a
BEAD IMP
IMPLANT,
consisting of a highly
ER
EXTENDED
purified drug intended
RELEASE
for implantation in the
body which would allow
at least a reduction in
dosing frequency as
compared to that drug
presented as a
conventional dosage
form.
BLOCK
Solid dosage form,
a,b
BLOCK
803
C42891
a,b,c
CAP
600
C25158
usually in the shape of a
square or rectangle.
CAPSULE
A solid oral dosage form
consisting of a shell and a
filling. The shell is
composed of a single
sealed enclosure, or two
halves that fit together
and which are sometimes
sealed with a
band. Capsule shells
may be made from
gelatin, starch, or
cellulose, or other
suitable materials, may
be soft or hard, and are
filled with solid or liquid
ingredients that can be
poured or squeezed.
CAPSULE,
A solid dosage form in
COATED
which the drug is
a,b
CAP
602
C42895
603
C42896
COATED
enclosed within either a
hard or soft soluble
container or "shell" made
from a suitable form of
gelatin; additionally, the
capsule is covered in a
designated coating.
CAPSULE,
A solid dosage form in
COATED
which the drug is
COATED
PELLETS
enclosed within either a
PELLETS
hard or soft soluble
container or "shell" made
from a suitable form of
gelatin; the drug itself is
in the form of granules to
which varying amounts
of coating have been
applied.
a,b,c
CAP
CAPSULE,
A solid dosage form in
a,b
CAP
COATED,
which the drug is
COATED
EXTENDED
enclosed within either a
ER
RELEASE
hard or soft soluble
611
C42917
container or "shell" made
from a suitable form of
gelatin; additionally, the
capsule is covered in a
designated coating, and
which releases a drug (or
drugs) in such a manner
to allow at least a
reduction in dosing
frequency as compared to
that drug (or drugs)
presented as a
conventional dosage
form.
CAPSULE,
A solid dosage form in
DELAYED
which the drug is
RELEASE
enclosed within either a
a,b,c
CAP DR
620
C42902
a,b,c
CAP DR
621
C42904
hard or soft soluble
container made from a
suitable form of gelatin,
and which releases a drug
(or drugs) at a time other
than promptly after
administration. Entericcoated articles are
delayed release dosage
forms.
CAPSULE,
A solid dosage form in
DELAYED
which the drug is
PELLETS
RELEASE
enclosed within either a
PELLETS
hard or soft soluble
container or "shell" made
from a suitable form of
gelatin; the drug itself is
in the form of granules to
which enteric coating has
been applied, thus
delaying release of the
drug until its passage into
the intestines.
CAPSULE,
A solid dosage form in
EXTENDED
which the drug is
RELEASE
enclosed within either a
a,b,c
CAP ER
610
C42916
a
CAP FILM
612
C42928
hard or soft soluble
container made from a
suitable form of gelatin,
and which releases a drug
(or drugs) in such a
manner to allow a
reduction in dosing
frequency as compared to
that drug (or drugs)
presented as a
conventional dosage
form.
CAPSULE,
A solid dosage form in
FILM COATED,
which the drug is
COATED
EXTENDED
enclosed within either a
ER
RELEASE
hard or soft soluble
container or "shell" made
from a suitable form of
gelatin; additionally, the
capsule is covered in a
designated film coating,
and which releases a drug
(or drugs) in such a
manner to allow at least a
reduction in dosing
frequency as compared to
that drug (or drugs)
presented as a
conventional dosage
form.
CAPSULE,
A solid dosage form in
a,b
CAP
GELATIN
which the drug is
GELATIN
COATED
enclosed within either a
COATED
605
C42936
606
C42954
hard or soft soluble
container made from a
suitable form of gelatin;
through a banding
process, the capsule is
coated with additional
layers of gelatin so as to
form a complete seal.
CAPSULE,
A solid dosage form in
LIQUID FILLED
which the drug is
enclosed within a
soluble, gelatin shell
which is plasticized by
the addition of a polyol,
such as sorbitol or
glycerin, and is therefore
of a somewhat thicker
consistency than that of a
hard shell capsule;
a,b
CAP LIQ
FILLED
typically, the active
ingredients are dissolved
or suspended in a liquid
vehicle.
CEMENT
A substance that serves to a
CEMENT
252
C45414
CIGARETT
253
C42678
produce solid union
between two surfaces.
CIGARETTE
A narrow tube of cut
a,b
tobacco (or other similar
E
material) enclosed in
paper and designed for
smoking.
CLOTH
A large piece of
a,b,c
CLOTH
845
C60884
a,b,c
CONC
280
C60891
a,b
CONE
049
C42900
relatively flat, absorbent
material that contains a
drug. It is typically used
for applying medication
or for cleansing.
CONCENTRAT
A liquid preparation of
E
increased strength and
reduced volume which is
usually diluted prior to
administration.
CONE
A solid dosage form
bounded by a circular
base and the surface
formed by line segments
joining every point of the
boundary of the base to a
common vertex. A cone
(usually containing
antibiotics) is normally
placed below the gingiva
after a dental extraction.
CORE,
An ocular system placed
a,b
CORE ER
804
C42919
EXTENDED
in the eye from which the
RELEASE
drug diffuses through a
a,b,c
CREAM
805
C28944
CREAM,
A cream dosage form that a,b,c
CREAM
365
C60897
AUGMENTED
enhances drug delivery.
AUG
membrane at a constant
rate over a specified
period.
CREAM
An emulsion,
semisolid3dosage form,
usually containing > 20%
water and volatiles5
and/or < 50%
hydrocarbons, waxes, or
polyols as the
vehicle. This dosage
form is generally for
external application to
the skin or mucous
membranes.
Augmentation does not
refer to the strength of the
drug in the dosage form.
NOTE: CDER has
decided to refrain from
expanding the use of this
dosage form due to
difficulties in setting
specific criteria that must
be met to be considered
"augmented”.
CRYSTAL
A naturally produced
a
CRYSTAL
051
C42901
a
CULTURE
281
C45415
a
DIAPHRAG
255
C47890
angular solid of definite
form in which the
ultimate units from
which it is built up are
systematically arranged;
they are usually evenly
spaced on a regular space
lattice.
CULTURE
The propagation of
microorganisms or of
living tissue sells in
special media conducive
to their growth.
DIAPHRAGM
A device usually
dome-shaped, worn
M
during copulation over
the cervical mouth for
prevention of conception
or infection.
DISC
A circular plate-like
a,b,c
DISC
256
C43525
a
DOUCHE
838
C42679
organ or structure.
DOUCHE
A liquid preparation,
intended for the irrigative
cleansing of the vagina,
that is prepared from
powders, liquid
solutions, or liquid
concentrates and contains
one or more chemical
substances dissolved in a
suitable solvent or
mutually miscible
solvents.
DRESSING
The application of
a,b,c
DRESSING
285
C42763
a
DDS
259
C17423
a,b,c
ELIXIR
807
C42912
EMULSION
052
C42913
various materials for
protecting a wound.
DRUG
Modern technology,
DELIVERY
distributed with or as a
SYSTEM
part of a drug product
that allows for the
uniform release or
targeting of drugs to the
body.
ELIXIR
A clear, pleasantly
flavored, sweetened
hydroalcoholic liquid
containing dissolved
medicinal agents; it is
intended for oral use.
EMULSION
A dosage form consisting a,b,c
of a two-phase system
comprised of at least two
immiscible liquids1, one
of which is dispersed as
droplets (internal or
dispersed phase) within
the other liquid (external
or continuous phase),
generally stabilized with
one or more emulsifying
agents. (Note: Emulsio
n is used as a dosage
form term unless a more
specific term is
applicable, e.g. cream,
lotion, ointment.)
ENEMA
A rectal preparation for
a,b,c
ENEMA
286
C42915
a,b
EXTRACT
287
C42929
a,b,c
FIBER ER
847
C60926
therapeutic, diagnostic,
or nutritive purposes.
EXTRACT
A concentrated
preparation of vegetable
or animal drugs obtained
by removal of the active
constituents of the
respective drugs with a
suitable menstrua,
evaporation of all or
nearly all of the solvent,
and adjustment of the
residual masses or
powders to the prescribed
standards.
FIBER,
A slender and elongated
EXTENDED
solid thread-like
RELEASE
substance that delivers
drug in such a manner to
allow a reduction in
dosing frequency as
compared to that drug (or
drugs) presented as a
conventional dosage
form.
FILM
A thin layer or coating.
a,b
FILM,
A drug delivery system in a,b,c
EXTENDED
the form of a film that
RELEASE
releases the drug over an
FILM
061
C42932
FILM ER
810
C42920
FILM
063
C42984
extended period in such a
way as to maintain
constant drug levels in
the blood or target tissue.
FILM,
A thin layer or coating
SOLUBLE
which is susceptible to
a,b
SOLUBLE
being dissolved when in
contact with a liquid.
FOR SOLUTION
A product, usually a
a,c
FOR SOL
848
C60927
a,c
FOR SUSP
849
C60928
a,c
FOR SUSP
850
C60929
064
C42933
solid, intended for
solution prior to
administration.
FOR
A product, usually a
SUSPENSION
solid, intended for
suspension prior to
administration.
FOR
A product, usually a
SUSPENSION,
solid, intended for
EXTENDED
suspension prior to
RELEASE
administration; once the
ER
suspension is
administered, the drug
will be released at a
constant rate over a
specified period.
GAS
Any elastic aeriform
fluid in which the
a,b,c
GAS
molecules are separated
from one another and so
have free paths.
GEL
A semisolid3 dosage
a,b,c
GEL
066
C42934
a,b
GEL DENT
806
C42906
a,b,c
GEL MET
851
C60930
a,b
GENERATO 289
C48193
form that contains a
gelling agent to provide
stiffness to a solution or a
colloidal dispersion.4 A
gel may contain
suspended particles.
GEL,
A combination of a
DENTIFRICE
dentifrice (formulation
intended to clean and/or
polish the teeth, and
which may contain
certain additional
agents), and a gel. It is
used with a toothbrush
for the purpose of
cleaning and polishing
the teeth.
GEL, METERED
A gel preparation, with
metered dose valves,
which allow for the
delivery of a uniform
quantity of gel upon each
activation.
GENERATOR
An apparatus for the
formation of vapor or gas
from a liquid or solid by
heat or chemical action.
The term GENERATOR
R
also applies to
radioactive columns from
which radionuclides are
provided.
GLOBULE
Also called pellets or
a,b
GLOBULE
808
C42937
a,b
GRAFT
290
C45416
pilules, are made of pure
sucrose, lactose, or other
polysaccharides. They
are formed into small
globular masses of
various sizes, and are
medicated by placing
them in a vial and adding
the liquid drug
attenuation in the
proportion not less than
one percent (v/w). After
shaking, the medicated
globules are dried at
temperatures not to
exceed 40 degrees
Centigrade.
GRAFT
A slip of skin or of other
tissue for implantation.
GRANULE
A small particle or grain.
a,b,c
GRAN
078
C42938
GRANULE,
A small medicinal
a,c
GRAN DR
820
C42903
DELAYED
particle or grain to which
RELEASE
an enteric or other
coating has been applied,
thus delaying release of
the drug until its passage
into the intestines.
GRANULE,
A small particle or grain
EFFERVESCEN
containing a medicinal
T
agent in a dry mixture
a,b,c
GRAN
080
C42909
809
C42939
819
C42940
EFFRV
usually composed of
sodium bicarbonate,
citric acid, and tartaric
acid which, when in
contact with water, has
the capability to release
gas, resulting in
effervescence.
GRANULE, FOR A small medicinal
SOLUTION
a,b
particle or grain made
GRAN
F/SOL
available in its more
stable dry form, to be
reconstituted with
solvent just before
dispensing; the granules
are so prepared to contain
not only the medicinal
agent, but the colorants,
flavorants, and any other
desired pharmaceutic
ingredient.
GRANULE, FOR A small medicinal
SUSPENSION
particle or grain made
available in its more
stable dry form, to be
reconstituted with
solvent just before
dispensing to form a
suspension; the granules
are so prepared to contain
a,b
GRAN
F/SUSP
not only the medicinal
agent, but the colorants,
flavorants, and any other
desired pharmaceutic
ingredient.
GRANULE, FOR A small medicinal
SUSPENSION,
particle or grain made
EXTENDED
available in its more
RELEASE
stable dry form, to be
a
GRAN
811
C42921
F/SUSP ER
reconstituted with
solvent just before
dispensing to form a
suspension; the extended
release system achieves
slow release of the drug
over an extended period
of time and maintains
constant drug levels in
the blood or target tissue.
GUM
A mucilaginous
a,b
GUM
084
C42941
a,b,c
GUM
085
C42894
087
C42978
excretion from various
plants.
GUM,
A sweetened and
CHEWING
flavored insoluble plastic
CHEWING
material of various
shapes which when
chewed, releases a drug
substance into the oral
cavity.
GUM, RESIN
Natural mixture of gum
and resin, usually
obtained as exudations
a,b
GUM
RESIN
from plants.
IMPLANT
A material containing
a,b,c
IMP
715
C42942
a,b,c
INHALANT
293
C42944
a,c
INJ LIPOS
852
C60931
a,b
INJ
700
C42946
drug intended to be
inserted securely of
deeply in a living site for
growth, slow release, or
formation of an organic
union.
INHALANT
A special class of
inhalations consisting of
a drug or combination of
drugs, that by virtue of
their high vapor pressure
can be carried by an air
current into the nasal
passage where they exert
their effect; the container
from which the inhalant
generally is administered
is known as an inhaler.
INJECTABLE,
An injection, which
LIPOSOMAL
either consists of or
forms liposomes (a lipid
bilayer vesicle usually
composed of
phospholipids which is
used to encapsulate an
active drug substance).
INJECTION
A sterile preparation
intended for parenteral
use; five distinct classes
of injections exist as
defined by the USP.
INJECTION,
An emulsion consisting
EMULSION
of a sterile, pyrogen-free
a,b
INJ
701
C42914
716
C42950
702
C42974
703
C42976
710
C42977
EMULSION
preparation intended to
be administered
parenterally.
INJECTION,
[definition pending]
a
LIPID
INJ LIPID
COMPLEX
COMPLEX
INJECTION,
A sterile preparation
POWDER, FOR
intended for
SOLUTION
reconstitution to form a
a,b
INJ PWD
F/SOL
solution for parenteral
use.
INJECTION,
A sterile preparation
POWDER, FOR
intended for
SUSPENSION
reconstitution to form a
a,b
INJ PWD
F/SUSP
suspension for parenteral
use.
INJECTION,
A dried preparation
POWDER, FOR
intended for
SUSPENSION,
reconstitution to form a
EXTENDED
suspension for parenteral
RELEASE
use which has been
formulated in a manner to
allow at least a reduction
in dosing frequency as
compared to that drug
presented as a
conventional dosage
form (e.g., as a solution).
a,b
INJ PWD
F/SUSP ER
INJECTION,
A sterile freeze dried
POWDER,
preparation intended for
LYOPHILIZED,
reconstitution for
FOR
parenteral use which has
LIPOSOMAL
been formulated in a
SUSPENSION
manner that would allow
a,b
INJ PWD
713
C42959
705
C42957
706
C42958
LYO F/LS
liposomes (a lipid bilayer
vesicle usually composed
of phospholipids which is
used to encapsulate an
active drug substance,
either within a lipid
bilayer or in an aqueous
space) to be formed upon
reconstitution.
INJECTION,
A dosage form intended
POWDER,
for the solution prepared
LYOPHILIZED,
by lyophilization ("freeze
FOR SOLUTION
drying"), a process which
a,b
INJ PWD
LYO F/SOL
involves the removal of
water from products in
the frozen state at
extremely low pressures;
this is intended for
subsequent addition of
liquid to create a solution
that conforms in all
respects to the
requirements for
Injections.
INJECTION,
A liquid preparation,
a,b
INJ PWD
POWDER,
intended for parenteral
LYO
LYOPHILIZED,
use that contains solids
F/SUSP
FOR
suspended in a suitable
SUSPENSION
fluid medium and
conforms in all respects
to the requirements for
Sterile Suspensions; the
medicinal agents
intended for the
suspension are prepared
by lyophilization ("freeze
drying"), a process which
involves the removal of
water from products in
the frozen state at
extremely low pressures.
INJECTION,
A sterile freeze dried
a,b
INJ PWD
POWDER,
preparation intended for
LYO
LYOPHILIZED,
reconstitution for
F/SUSPER
FOR
parenteral use which has
SUSPENSION,
been formulated in a
EXTENDED
manner to allow at least a
RELEASE
reduction in dosing
712
C42956
708
C42945
frequency as compared to
that drug presented as a
conventional dosage
form (e.g., as a solution).
INJECTION,
A liquid preparation
SOLUTION
containing one or more
drug substances
dissolved in a suitable
solvent or mixture of
mutually miscible
solvents that is suitable
for injection.
a,b
INJ SOL
INJECTION,
A sterile preparation for
SOLUTION,
parenteral use which,
CONCENTRAT
upon the addition of
E
suitable solvents, yields a
a,b
INJ SOL
709
C42899
CONC
solution conforming in
all respects to the
requirements for
Injections.
INJECTION,
A liquid preparation,
SUSPENSION
suitable for injection,
a,b
INJ SUSP
704
C42995
a,b
INJ SUSP
711
C42926
which consists of solid
particles dispersed
throughout a liquid phase
in which the particles are
not soluble. It can also
consist of an oil phase
dispersed throughout an
aqueous phase, or
vice-versa.
INJECTION,
A sterile preparation
SUSPENSION,
intended for parenteral
EXTENDED
use which has been
RELEASE
formulated in a manner to
allow at least a reduction
in dosing frequency as
compared to that drug
presented as a
conventional dosage
form (e.g., as a solution
or a prompt
drug-releasing,
conventional solid
dosage form).
ER
INJECTION,
A liquid preparation,
SUSPENSION,
suitable for injection,
LIPOSOMAL
which consists of an oil
a,b
INJ SUSP
714
C42951
840
C42988
853
C60933
LIPOS
phase dispersed
throughout an aqueous
phase in such a manner
that liposomes (a lipid
bilayer vesicle usually
composed of
phospholipids which is
used to encapsulate an
active drug substance,
either within a lipid
bilayer or in an aqueous
space) are formed.
INJECTION,
A liquid preparation,
SUSPENSION,
suitable for injection,
SONICATED
which consists of solid
a
INJ SUSP
SON
particles dispersed
throughout a liquid phase
in which the particles are
not soluble. In addition,
the product is sonicated
while a gas is bubbled
through the suspension,
and this results in the
formation of
microspheres by the solid
particles.
INSERT
A specially formulated
and shaped
non-encapsulated solid
preparation intended to
a,c
INSERT
be placed into a
non-rectal orifice of the
body, where drug is
released, generally for
localized effects.
INSERT,
A specially formulated
EXTENDED
and shaped
RELEASE
non-encapsulated solid
a,b,c
INSERT ER
812
C42922
IUD
260
C47915
IRRIGANT
830
C42947
JELLY
072
C42948
preparation intended to
be placed into a
non-rectal orifice of the
body, where the
medication is released,
generally for localized
effects; the extended
release preparation is
designed to allow for a
reduction in dosing
frequency.
INTRAUTERIN
A device inserted and left a,b,c
E DEVICE
in the uterus to prevent
effective conception.
IRRIGANT
A sterile solution
a,b
intended to bathe or flush
open wounds or body
cavities; they're used
topically, never
parenterally.
JELLY
A class of gels, which are a,b,c
semisolid systems that
consist of suspensions
made up of either small
inorganic particles or
large organic molecules
interpenetrated by a
liquid--in which the
structural coherent
matrix contains a high
portion of liquid, usually
water.
KIT
A packaged collection of
a,b
KIT
261
C47916
a,b
LINER
316
C45413
related material.
LINER,
A material applied to the
DENTAL
inside of the dental
DENTAL
cavity, for protection or
insulation of the surface.
LINIMENT
A solution or mixture of
a,b
LINIMENT
298
C42949
a,b
LIPSTICK
265
C42952
LIQ
299
C42953
LIQ ER
854
C60934
various substances in oil,
alcoholic solutions of
soap, or emulsions
intended for external
application.
LIPSTICK
A waxy solid, usually
colored cosmetic, in stick
form for the lips.
LIQUID
A dosage form consisting a,b,c
of a pure chemical in its
liquid1 state. This
dosage form term should
not be applied to
solutions.
LIQUID,
A liquid that delivers a
EXTENDED
drug in such a manner to
a,b,c
RELEASE
allow a reduction in
dosing frequency as
compared to that drug (or
drugs) presented as a
conventional dosage
form.
LOTION
An emulsion,
a,b,c
LOTION
300
C29167
LOTION,
A lotion dosage form that a,b,c
LOTION
364
C60957
AUGMENTED
enhances drug delivery.
AUG
855
C60958
831
C42955
liquid1dosage
form. This dosage form
is generally for external
application to the skin.2
Augmentation does not
refer to the strength of the
drug in the dosage form.
NOTE: CDER has
decided to refrain from
expanding the use of this
dosage form due to
difficulties in setting
specific criteria that must
be met to be considered
"augmented".
LOTION/SHAM
A lotion dosage form
POO
which has a soap or
a,b,c
LOTION
SHAMPOO
detergent that is usually
used to clean the hair and
scalp; it is often used as a
vehicle for dermatologic
agents.
LOZENGE
A solid preparation
a,b
LOZENGE
containing one or more
medicaments, usually in
a flavored, sweetened
base which is intended to
dissolve or disintegrate
slowly in the mouth. A
lollipop is a lozenge on a
stick.
MOUTHWASH
An aqueous solution
a,b
which is most often used
MOUTHWA
832
C29269
313
C48624
SH
for its deodorant,
refreshing, or antiseptic
effect.
NOT
The use of a dosage form
APPLICABLE
term is not relevant or
APPLICAB
appropriate.
LE
OIL
An unctuous,
a,b,c
NOT
a,b,c
OIL
098
C42965
a,b,c
OINTMENT
101
C42966
combustible substance
which is liquid, or easily
liquefiable, on warming,
and is soluble in ether but
insoluble in water. Such
substances, depending on
their origin, are classified
as animal, mineral, or
vegetable oils.
OINTMENT
A semisolid3 dosage
form, usually containing
<20% water and
volatiles5 and >50%
hydrocarbons, waxes, or
polyols as the
vehicle. This dosage
form is generally for
external application to
the skin or mucous
membranes.
OINTMENT,
An ointment dosage form a,b,c
OINTMENT
AUGMENTED
that enhances drug
AUG
366
C60984
delivery. Augmentation
does not refer to the
strength of the drug in the
dosage form. NOTE:
CDER has decided to
refrain from expanding
the use of this dosage
form due to difficulties in
setting specific criteria
that must be met to be
considered "augmented".
PACKING
A material, usually
a,b
PACKING
839
C47887
a,b,c
PASTE
103
C42967
covered by or
impregnated with a drug
that is inserted into a
body cavity or between
the tooth enamel and the
gingival margin.
PASTE
A semisolid3 dosage
form, containing a large
proportion (20 – 50%) of
solids finely dispersed in
a fatty vehicle. This
dosage form is generally
for external application
to the skin or mucous
membranes.
PASTE,
A paste formulation
DENTIFRICE
intended to clean and/or
a,b
PASTE
104
C42907
DENT
polish the teeth, and
which may contain
certain additional agents.
PASTILLE
An aromatic preparation,
a,c
PASTILLE
341
C60985
a,b,c
PATCH
843
C42968
PATCH ER
813
C42923
often with a pleasing
flavor, usually intended
to dissolve in the mouth.
PATCH
A drug delivery system
that often contains an
adhesive backing that is
usually applied to an
external site on the
body. Its ingredients
either passively diffuse
from, or are actively
transported from, some
portion of the
patch. Depending upon
the patch, the ingredients
are either delivered to the
outer surface of the body
or into the body. A
patch is sometimes
synonymous with the
terms ‘extended release
film’ and ‘system’.
PATCH,
A drug delivery system in a,b
EXTENDED
the form of a patch that
RELEASE
releases the drug in such
a manner that a reduction
in dosing frequency
compared to that drug
presented as a
conventional dosage
form (e.g., a solution or a
prompt drug-releasing,
conventional solid
dosage form).
PATCH,
A drug delivery system in a,b
PATCH ER
EXTENDED
the form of a patch which
ELCON
RELEASE,
is controlled by an
ELECTRICALL
electric current that
Y
releases the drug in such
CONTROLLED
a manner that a reduction
814
C42911
105
C42969
in dosing frequency
compared to that drug
presented as a
conventional dosage
form (e.g., a solution or a
prompt drug-releasing,
conventional solid
dosage form).
PELLET
A small sterile solid mass a,b,c
consisting of a highly
purified drug (with or
without excipients) made
by the formation of
granules, or by
compression and
molding.
PELLET
PELLET,
A small sterile solid mass a
PELLET
IMPLANTABLE
consisting of a highly
IMP
844
C42943
842
C42918
107
C25394
purified drug (with or
without excipients) made
by the formation of
granules, or by
compression and
molding; they are
intended for implantation
in the body (usually
subcutaneously) for the
purpose of providing
continuous release of the
drug over long periods of
time.
PELLETS,
A solid dosage form in
a
PELLETS
COATED,
which the drug itself is in
COATED
EXTENDED
the form of granules to
ER
RELEASE
which varying amounts
of coating have been
applied, and which
releases a drug (or drugs)
in such a manner to allow
a reduction in dosing
frequency as compared to
that drug (or drugs)
presented as a
conventional dosage
form.
PILL
A small, round solid
dosage form containing a
medicinal agent intended
for oral administration.
a,b
PILL
PLASTER
Substance intended for
a,b
PLASTER
108
C42970
a,b
POULTICE
109
C47913
a,b,c
PWD
110
C42972
a,b
PWD DENT
115
C42908
a,b
PWD F/SOL
833
C42973
external application
made of such materials
and of such consistency
as to adhere to the skin
and attach to a dressing;
plasters are intended to
afford protection and
support and/or to furnish
an occlusion and
macerating action and to
bring medication into
close contact with the
skin.
POULTICE
A soft, moist mass of
meal, herbs, seed, etc.,
usually applied hot in
cloth that consists of
gruel-like consistency.
POWDER
An intimate mixture of
dry, finely divided drugs
and/or chemicals that
may be intended for
internal or external use.
POWDER,
A powder formulation
DENTIFRICE
intended to clean and/or
polish the teeth, and
which may contain
certain additional agents.
POWDER, FOR
An intimate mixture of
SOLUTION
dry, finely divided drugs
and/or chemicals, which,
upon the addition of
suitable vehicles, yields a
solution.
POWDER, FOR
An intimate mixture of
SUSPENSION
dry, finely divided drugs
a,b
PWD
834
C42975
F/SUSP
and/or chemicals, which,
upon the addition of
suitable vehicles, yields a
suspension (a liquid
preparation containing
the solid particles
dispersed in the liquid
vehicle).
POWDER,
An powder dosage form
METERED
that is situated inside a
a,c
PWD MET
841
C42961
a,b,c
RING
856
C60988
a,b
RINSE
303
C42979
a,b
SALVE
137
C42980
container that has a
mechanism to deliver a
specified quantity.
RING
A small circular object
with a vacant circular
center that is usually
intended to be placed in
the body by special
inserters, where the
medication is released,
generally for localized
effects.
RINSE
A liquid used to cleanse
by flushing.
SALVE
A thick ointment or
cerate (a fat or wax based
preparation with a
consistency between an
ointment and a plaster).
SHAMPOO
A liquid soap or
a,b,c
SHAMPOO
304
C42981
a,b
SHAMPOO
193
C42982
detergent used to clean
the hair and scalp and is
often used as a vehicle
for dermatologic agents.
SHAMPOO,
A liquid soap or
SUSPENSION
detergent containing one
SUSP
or more solid, insoluble
substances dispersed in a
liquid vehicle that is used
to clean the hair and scalp
and is often used as a
vehicle for dermatologic
agents.
SOAP
Any compound of one or
a,b,c
SOAP
305
C42983
a,b,c
SOL
138
C42986
more fatty acids, or their
equivalents, with an
alkali; soap is detergent
and is much employed in
liniments, enemas, and in
making pills. It is also a
mild aperient, antacid
and antiseptic.
SOLUTION
A clear, homogeneous
liquid1 dosage form that
contains one or more
chemical substances
dissolved in a solvent or
mixture of mutually
miscible solvents.
SOLUTION,
A liquid preparation (i.e., a,b
CONCENTRAT
a substance that flows
E
readily in its natural
SOL CONC
835
C42898
SOL
321
C42987
858
C60994
717
C42935
state) that contains a drug
dissolved in a suitable
solvent or mixture of
mutually miscible
solvents; the drug has
been strengthened by the
evaporation of its
nonactive parts.
SOLUTION,
A solution for the
FOR SLUSH
preparation of an iced
a,c
F/SLUSH
saline slush, which is
administered by
irrigation and used to
induce regional
hypothermia (in
conditions such as certain
open heart and kidney
surgical procedures) by
its direct application.
SOLUTION,
A solution, which after
a,c
GEL FORMING / usually being
DROPS
SOL GF
DROPS
administered in a
drop-wise fashion, forms
a gel.
SOLUTION,
A solution that forms a
GEL FORMING,
gel when it comes in
EXTENDED
contact with ocular fluid,
RELEASE
and which allows at least
a
SOL GF ER
a reduction in dosing
frequency.
SOLUTION/
A solution which is
DROPS
usually administered in a
a,b,c
SOL DROPS
857
C60992
a,b,c
SPONGE
271
C47912
a,b,c
SPRAY
272
C42989
a,b,c
SPRAY
345
C42962
195
C42990
drop-wise fashion.
SPONGE
A porous, interlacing,
absorbent material that
contains a drug. It is
typically used for
applying or introducing
medication, or for
cleansing. A sponge
usually retains its shape.
SPRAY
A liquid minutely
divided as by a jet of air
or steam.
SPRAY,
A non-pressurized
METERED
dosage form consisting
MET
of valves which allow the
dispensing of a specified
quantity of spray upon
each activation.
SPRAY,
A liquid preparation
SUSPENSION
containing solid particles
dispersed in a liquid
vehicle and in the form of
coarse droplets or as
finely divided solids to be
applied locally, most
usually to the
nasal-pharyngeal tract, or
a,b
SPRAY
SUSP
topically to the skin.
STICK
A dosage form prepared
a,b
STICK
273
C42991
a,b
STRIP
274
C47914
a,b,c
SUPP
173
C42993
SUPP ER
815
C42924
a,b
SUSP
177
C42994
a,b
SUSP ER
816
C42925
in a relatively long and
slender often cylindrical
form.
STRIP
A long narrow piece of
material.
SUPPOSITORY
A solid body of various
weights and shapes,
adapted for introduction
into the rectal orifice of
the human body; they
usually melt, soften, or
dissolve at body
temperature.
SUPPOSITORY,
A drug delivery system in a,b,c
EXTENDED
the form of a suppository
RELEASE
that allows for a
reduction in dosing
frequency.
SUSPENSION
A liquid1 dosage form
that contains solid
particles dispersed in a
liquid vehicle.
SUSPENSION,
A liquid preparation
EXTENDED
consisting of solid
RELEASE
particles dispersed
throughout a liquid phase
in which the particles are
not soluble; the
suspension has been
formulated in a manner to
allow at least a reduction
in dosing frequency as
compared to that drug
presented as a
conventional dosage
form (e.g., as a solution
or a prompt
drug-releasing,
conventional solid
dosage form).
SUSPENSION/
A suspension which is
DROPS
usually administered in a
a,c
SUSP
859
C60995
DROPS
dropwise fashion.
SUTURE
A strand or fiber used to
a
SUTURE
275
C47889
a,b,c
SWAB
276
C47898
a,b,c
SYRUP
307
C42996
hold wound edges in
apposition during
healing.
SWAB
A small piece of
relatively flat absorbent
material that contains a
drug. A swab may also
be attached to one end of
a small stick. A swab is
typically used for
applying medication or
for cleansing.
SYRUP
An oral solution
containing high
concentrations of sucrose
or other sugars; the term
has also been used to
include any other liquid
dosage form prepared in
a sweet and viscid
vehicle, including oral
suspensions.
TABLET
A solid dosage form
a,b,c
TAB
500
C42998
a,b,c
TAB CHEW
501
C42893
a,b
TAB
502
C42897
860
C60997
containing medicinal
substances with or
without suitable diluents.
TABLET,
A solid dosage form
CHEWABLE
containing medicinal
substances with or
without suitable diluents
that is intended to be
chewed, producing a
pleasant tasting residue
in the oral cavity that is
easily swallowed and
does not leave a bitter or
unpleasant after-taste.
TABLET,
A solid dosage form that
COATED
contains medicinal
COATED
substances with or
without suitable diluents
and is covered with a
designated coating.
TABLET,
A solid dosage form
COATED
containing a
COATED
PARTICLES
conglomerate of
PART
medicinal particles that
have each been covered
with a coating.
a,c
TAB
TABLET,
A solid dosage form
DELAYED
which releases a drug (or
RELEASE
drugs) at a time other
a,b,c
TAB DR
520
C42905
a,b
TAB DR
521
C42997
491
[Note: The
than promptly after
administration. Entericcoated articles are
delayed release dosage
forms.
TABLET,
A solid dosage form
DELAYED
containing a
RELEASE
conglomerate of
PARTICLES
medicinal particles that
PARTICLES
have been covered with a
coating which releases a
drug (or drugs) at a time
other than promptly after
administration. Entericcoated articles are
delayed release dosage
forms.
TABLET,
A tablet that, prior to
DISPERSIBLE
administration, is
concept has
intended to be placed in
been entered
liquid, where its contents
as a synonym
will be distributed evenly
for the
throughout that
dosage form
liquid. Note: The term
term
‘tablet, dispersible’ is no
TABLET,
longer used for approved
FOR
drug products, and it has
SUSPENSIO
been replaced by the term
N.]
‘tablet, for suspension’.
a,c
TAB DISP
TABLET,
A solid dosage form
EFFERVESCEN
containing mixtures of
T
acids (e.g., citric acid,
a,b,c
TAB EFFRV
503
C42910
a,b,c
TAB ER
510
C42927
a,b
TAB FILM
504
C42931
511
C42930
tartaric acid) and sodium
bicarbonate, which
release carbon dioxide
when dissolved in water;
it is intended to be
dissolved or dispersed in
water before
administration.
TABLET,
A solid dosage form
EXTENDED
containing a drug which
RELEASE
allows at least a reduction
in dosing frequency as
compared to that drug
presented in conventional
dosage form.
TABLET, FILM
A solid dosage form that
COATED
contains medicinal
COATED
substances with or
without suitable diluents
and is coated with a thin
layer of a water-insoluble
or water-soluble
polymer.
TABLET, FILM
A solid dosage form that
COATED,
contains medicinal
COATED
EXTENDED
substances with or
ER
RELEASE
without suitable diluents
and is coated with a thin
layer of a water-insoluble
a,b
TAB FILM
or water-soluble
polymer; the tablet is
formulated in such
manner as to make the
contained medicament
available over an
extended period of time
following ingestion.
TABLET, FOR
A tablet that forms a
SOLUTION
solution when placed in a
a,c
TAB FOR
523
C61004
524
C61005
505
C42964
512
C42963
SOL
liquid.
TABLET, FOR
A tablet that forms a
SUSPENSION
suspension when placed
a,c
TAB FOR
SUSP
in a liquid (formerly
referred to as a
‘dispersible tablet’).
TABLET,
A solid dosage form
a,b
TAB
MULTILAYER
containing medicinal
MULTILAY
substances that have been
ER
compressed to form a
multiple-layered tablet or
a tablet-within-a-tablet,
the inner tablet being the
core and the outer portion
being the shell.
TABLET,
A solid dosage form
MULTILAYER,
containing medicinal
MULTILAY
EXTENDED
substances that have been
ER ER
RELEASE
compressed to form a
multiple-layered tablet or
a tablet-within-a-tablet,
the inner tablet being the
a,b
TAB
core and the outer portion
being the shell, which,
additionally, is covered
in a designated coating;
the tablet is formulated in
such manner as to allow
at least a reduction in
dosing frequency as
compared to that drug
presented as a
conventional dosage
form.
TABLET,
A solid dosage form
a,b,c
TAB
ORALLY
containing medicinal
ORALLY
DISINTEGRATI
substances which
DIS
NG
disintegrates rapidly,
522
C42999
526
C61006
507
C42985
usually within a matter of
seconds, when placed
upon the tongue.
TABLET,
A solid dosage form
a,c
TAB
ORALLY
containing medicinal
ORALLY
DISINTEGRATI
substances which
DIS DR
NG, DELAYED
disintegrates rapidly,
RELEASE
usually within a matter of
seconds, when placed
upon the tongue, but
which releases a drug (or
drugs) at a time other
than promptly after
administration.
TABLET,
A solid dosage form that
SOLUBLE
contains medicinal
a,b
TAB
SOLUBLE
substances with or
without suitable diluents
and possesses the ability
to dissolve in fluids.
TABLET,
A solid dosage form that
a,b
TAB
SUGAR
contains medicinal
SUGAR
COATED
substances with or
COATED
508
C42992
without suitable diluents
and is coated with a
colored or an uncolored
water-soluble sugar.
TAMPON
A plug made of cotton,
a,b,c
TAMPON
277
C47892
a,b,c
TAPE
278
C47897
a,b
TINCTURE
837
C43000
a,b
TROCHE
363
C43001
sponge, or oakum
variously used in surgery
to plug the nose, vagina,
etc., for the control of
hemorrhage or the
absorption of secretions.
TAPE
A narrow woven fabric,
or a narrow extruded
synthetic (such as
plastic), usually with an
adhesive on one or both
sides.
TINCTURE
An alcoholic or
hydroalcoholic solution
prepared from vegetable
materials or from
chemical substances.
TROCHE
A discoid-shaped solid
containing the medicinal
agent in a suitably
flavored base; troches are
placed in the mouth
where they slowly
dissolve, liberating the
active ingredients.
UNASSIGNED
A dosage form has yet to
a,b
be assigned.
WAFER
A thin slice of material
UNASSIGN
900
C43002
245
C43003
ED
a,b
WAFER
containing a medicinal
agent.
Footnotes:
1
A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian
or pseudoplastic flow behavior.
2
Previously the definition of a lotion was “The term lotion has been used to categorize many topical
suspensions, solutions, and emulsions intended for application to the skin.” The current definition of a
lotion is restricted to an emulsion.
3
A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does
not flow at low shear stress and generally exhibits plastic flow behavior.
4
A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm
and 1 µm) are distributed uniformly throughout a liquid.
5
Percent water and volatiles are measured by a loss on drying test in which the sample is heated at
105°C until constant weight is achieved.