Glossary
Active Ingredients
According to 21 CFR 210.3(b)(7), an active ingredient is any component of a drug
product intended to furnish pharmacological activity or other direct effect in the
diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the
structure or any function of the body of humans or other animals. Active ingredients
include those components of the product that may undergo chemical change during
the manufacture of the drug product and be present in the drug product in a
modified form intended to furnish the specified activity or effect.
CFR Search Link:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
Active Moiety
According to 21 CFR 314.108(a), the molecule or ion, excluding those appended
portions of the molecule that cause the drug to be an ester, salt (including a salt with
hydrogen or coordination bonds), or other non-covalent derivative (such as a
complex, chelate, or clathrate) of the molecule, responsible for the physiological or
pharmacological action of the drug substance.
CFR Search Link:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
Application Number
This number, also known as the NDA (New Drug Application) number, is assigned by
FDA staff to each application for approval to market a new drug in the United States.
One drug can have more than one application number if it has different dosage
forms or routes of administration.
Drugs@FDA Link: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
ANADA
Abbreviated New Animal Drug Application – Used to seek approval of a new animal
drug and any subsequent supplemental applications
FDA ANADA Link:
Doc-To-Help Standard Template
Glossary  1
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/NewAnimalDr
ugApplications/default.htm
ANDA
Abbreviated New Drug Application - Used to seek approval for a generic new drug
copied from an approved new animal drug where the patents or period of exclusivity
is new expiration
Link:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopeda
ndApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/
default.htm
Analysis
The process of which anything complex is separated into simple, less complex parts
Basis of Strength
Basis of strength is used to define if the active ingredient’s strength (as identified in
the SPL product data elements) is defined based on the active ingredient, active
moiety, or a reference drug.
BLA
A biologics license application is a submission that contains specific information on
the manufacturing processes, chemistry, pharmacology, clinical pharmacology and
the medical affects of the biologic product.
BLA Link:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopeda
ndApproved/ApprovalApplications/TherapeuticBiologicApplications/default.htm
Black Box Warning
A warning surrounded by a black box that appears on the package insert and advises
that the drug carries a significant risk of serious or life-threatening adverse effects
Bulk Ingredient
According to 21 CFR 207.3(a)(4), Any substance that is represented for use in a drug
and that, when used in the manufacturing, processing, or packaging of a drug,
becomes an active ingredient or a finished dosage form of the drug
FDA CFR Link:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=
207&showFR=1
Business Operation
Operations relating to a product performed by establishments
FDA Approved Business Operations Link:
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162
527.htm
Characteristics
Physical characteristics associated only with solid oral dosage forms.
Conditional NADA
Conditional New Animal Drug Application – Allows a drug sponsor to legally market
the new animal drug after proven sage but before collecting all necessary
effectiveness data
FDA CNADA Link:
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/NewAnimalDr
ugApplications/default.htm
Content of Labeling
Also referred to as the package insert, the content of labeling is comprised of all text,
tables, and images
DEA Schedule
Used to identify the appropriate Drug Enforcement Agency (DEA) schedule
associated to the product.
DEA Scheduling Link: http://www.justice.gov/dea/pubs/scheduling.html
Delisting
Physical characteristics associated only with solid oral dosage forms.
Doc-To-Help Standard Template
Glossary  3
Established Name
The generic name for the product, typically these are the active ingredients for the
product.
Establishment
According to 21 CFR 207.3(a)(7), Place of business under one management at one
general physical location
CFR Search Link:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=
207&showFR=1
Establishment Registration
The owner or operator of an establishment that performs business operations on a
drug are required to annually register their establishment with the FDA before
December 31 of each year
DFARS Link: http://www.fda.gov/Drugs/InformationOnDrugs/ucm135778.htm
Inactive Ingredient
According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug
product other than the active ingredient.
CFR Search Link:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
IND
Investigational New Drug – An exemption that allows an investigational drug to be
shipped to clinical investigators without an approved marketing application
Kit
Multiple products that are packaged together i.e. birth control, injection kits
Labeler
A labeler is any firm that manufactures (including repackers or relabelers), or
distributes (under its own name) the drug
Labeler Code
A 4 or 5 digit code assigned by the FDA to a firm that manufactures or distributes the
drug
LOINC
Logical Observation Identifiers Names and Codes – LOINCs help facilitate the
exchange and pooling of clinical results for clinical care, outcomes management, and
research by providing a set of universal codes and names to identify laboratory and
other clinical observations.
Updated LOINC list:
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162
057.htm
Manufacture
According to 21 CFR 207.3(a)(8), the preparation, propagation, compounding, or
processing of raw materials
CFR Search Link:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=
207&showFR=1
Manufactured Product
Unique strength and dosage form for a product
Marketing Category
Defines the type of drug approval associated to the product
FDA Accepted Marketing Categories:
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162
528.htm
Marketing Start Date
Date indentifying when a product is first marketed to the public
Doc-To-Help Standard Template
Glossary  5
Marketing Status
Distinguishes between active and completed marketing categories, a field utilized by
the FDA and the Daily Med to determine delisted products (completed status)
NADA
New Animal Drug Application – Application for a new animal drug regarding
effectiveness and safety for targeted animal and any human which may consume
products from the treated animal
FDA NADA Link:
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/NewAnimalDr
ugApplications/default.htm
NDA
New Drug Application – Application for a new pharmaceutical
NDA Link:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopeda
ndApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm
NDA Authorized Generic
New Drug Application – Refers to a product that while called a generic, is in fact
marketed under color of an approved new drug application and does not refer to a
true generic drug marketed under an approved abbreviated new drug application,
nor does it include an NDA product sold by a company with the right to generic
exclusivity
NDC Code
Each listed drug product is assigned a unique 10-digit, 3-segment number. This
number, known as the NDC, identifies the labeler, product, and trade package size.
The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that
manufactures (including repackers or relabelers), or distributes (under its own name)
the drug. The second segment, the product code, identifies a specific strength,
dosage form, and formulation of a drug for a particular firm. Different formulations
or different strengths of the same formulation should be assigned different product
codes. This means even if the same formulations of a drug product ultimately deliver
different strengths of the active ingredient to the recipient, they should be assigned
different product codes. Also, drug products that share the same formulation but
have different product characteristics that clearly distinguish one drug product
version from another cannot share the same product code under the same labeler
code. The third segment, the package code, identifies package sizes and types.
Different package codes only differentiate between different quantitative and
qualitative attributes of the product packaging. Both the product and package codes
are assigned by the firm. The NDC will be in one of the following configurations: 4-42, 5-3-2, or 5-4-1.
NDC Directory Link:
http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm
Pack
The process of bundling or forming into a group
Part
Unique products packaged together into a kit
Proprietary Name
Exclusive name of a drug substance or drug product owned under trademark,
marketed name as it appears on the label
Outside Entity
Any establishment that your company contracts with but is not responsible for
registering annually with the FDA
Registrant
Entity in charge of registering an establishment
Route(s) of Administration
How the product is delivered to the body
FDA Accepted Route of Administration List:
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162
034.htm
RLD
Reference Listed Drug – Drug used to compare effects and safety with the trial drug
Doc-To-Help Standard Template
Glossary  7
Source Drug NDC Product Code
NDC code that indicates the source the product is based upon
SPL
Structured Product Labeling – document markup standard used as a mechanism for
exchanging product information
UNII
Unique Ingredient Identifier – unique identifiers for substances in drugs, biologics,
foods and devices based on molecular structures and/or descriptive substances in
regulated products
FDA UNII Search: http://fdasis.nlm.nih.gov/srs/srs.jsp
US Agent
US Agents are contact points for importing drug products into the United States
US Importer
US Importers actually bring the drugs into the United States with the assistance of a
US Agent
Validation
Validation does not mean a drug submission has been accepted by the FDA, it just
means the file was accepted into the FDA’s system successfully.
XML
Extensible Markup Language – set of rules for encoding documents in machinereadable form