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8/8/2019 National Drug Code Primer
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TMPharmaceutical Primer
WHAT IS AN NDC?
NDC is an acronym for National Drug
Code. The NDC directory was established
by the US Food and Drug Administration
to serve as a universal product identifier
for human drugs. Each drug product listed
under Section 510 of the Federal Food,
Drug and Cosmetic Act is assigned aunique 10 or 11-digit, 3-segment number.
This number, or NDC, identifies three
aspects of the drug, as illustrated below.
■ ■ ■ National Drug Code (NDC) Primer
PHARMACEUTICAL SERVICESTM
Who We Are
Strong Pharmaceutical Services, a division of Strong Environmental, Inc., is the leading
provider of destruction services to the pharmaceutical industry. Our experienced
professionals manage and ensure the appropriate witnessed destruction of DEA
controlled substances, as well as proper disposition of RCRA hazardous and non-
hazardous finished goods and manufacturing wastes. When we take control of waste
materials at your shipping dock, they become our full responsibility.
Stron Pharmaceutical Services: Secure Pharmaceutical Destruction Solutions
Strong Pharmaceutical Service
a division of Strong Environmental, Inc
6264 Crooked Creek Road Norcross, GA 30092
770.409.1500 800.778.766
www.StrongPharma.com [email protected]
© Copyright 2008,Strong Environmental, In
LABELER CODE PRODUCT CODE
PACKAGE CODE
LABELER CODE: Identifies the firm that
manufactures, repacks, or distributes
that particular drug product.
PRODUCT CODE: Identifies a specific
strength, dosage form, and formulation
for a particular labeler.
PACKAGE CODE: Identifies package
size.
The NDC will be in one of the following
configurations: 4-4-2, 5-3-2, 5-4-1 or 5-4-2.
The example at bottom left illustrates the
5-4-2 format. Formats may include leading
zeros. Both the product and package
codes are assigned by the labeler.
WHAT DOES A “**” MEAN
AT THE END OF AN NDC?
The “**” indicates a bulk solid or bulk
liquid product. In the case of finished
goods, it is typically a single solid unit
dose (tablet, vial, capsule), or a ml of
liquid.
WHERE CAN I FIND
MORE INFORMATION ABOUT NDCs?
http://www.fda.gov/cder/ndc
REGULATED PHARMACEUTICALS CHART
As a service to the pharmaceutical
manufacturing and distribution
community, Strong publishes our
Regulated Pharmaceuticals Chart,
illustrated above right, which includes
the contents of this primer, as well
as more information about hazardous
pharmaceutical wastes, regulatory
agencies, controlled substances, listed
chemicals and more.
To request a copy of the poster for your
reference, please contact Strong at
770.409.1500, or via e-mail at Solutions@
StrongServices.com.
To request a copy of the poster for your
reference, please contact Strong at
