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Help with PharmCatalyst's NDC Database Searches
What are the parts of an NDC?
The National Drug Code (NDC) has 3 parts, identifying the labeler/vendor, product, and
package size.
The labeler code represents a company and is the group of numbers before the
first dash. A labeler is any firm that manufactures, repacks or distributes a drug product. If you don't know the labeler code for a
company and you need it for a search of a company's drugs, you can get the
labeler code (and product code) by doing an "NDC Search Using Brand
Name" with any drug that you know that company markets.
The product code is the second part, often between two dashes. It corresponds
to a drug, and identifies a specific strength, dosage
form, and formulation for a particular firm.
The third segment, the package code, identifies package sizes. Do not
use the package code when searching the database.
An NDC in the FDA's database is always 10 numbers and will be in one of the following configurations: 4-4-2, 5-3-2, or
5-4-1. For consistency, some agencies, organizations or computer systems may display
or want the NDC in an eleven
digit format -- the labeler code as 5 digits with leading zeros if needed; the product code as 4
digits with leading zeros if needed; the package size as 2 characters with leading
zeros when needed.
Why is the NDC that I'm looking for not found?
Maybe:
- the firm has not submitted the listing information to the FDA;
- the firm has notified the FDA that the product is no longer being
marketed;
- firm has not complied fully with the listing process so the product is
considered pending until complete information is provided in accordance with
21 CFR 207.
What is the source of the data and other info on this
page?
The FDA.
Why did the search yield unexpected results?
Marketing agreements between/among pharmaceutical firms is a common
cause. Not all NDCs in the FDA database are actually used in the marketplace.
How current is the Data?
The data is updated quarterly within 5 working days after the end of March,
June, September, and December.
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