NDC Codes
Background

Extracted from the NDC website:

“The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution.  (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360).  Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which is a universal product identifier for human drugs.  FDA inputs the full NDC number and the information submitted as part of the listing process into a database known as the Drug Registration and Listing System (DRLS).  Several times a year, FDA extracts some of the information from the DRLS data base (currently, properly listed marketed prescription drug products and insulin) and publishes that information in the NDC Directory.”

The current edition of the NDC Directory is limited to prescription drugs and insulin products that have been manufactured, prepared, propagated, compounded, or processed by registered establishments for commercial distribution. OTC products other than insulin products are not included. A drug may also not be listed if the responsible firm has notified the FDA that the drug is no longer being marketed, or if the firm has not complied fully with its listing obligations.

Note: Viewing/Filtering content is free for all datasets below.

NDC Codes Datasets
The following are the various datasets available on CDH for NDC Codes. Please note that some of the datasets require a paid subscription (indicated by the symbol), primarily due to the value-add of consolidating various sources, additional attributes, and incremental updates. All reasonable commercial attempt is made to keep the information up-to-date.
HPO1 NDC Numbers List of active NDC numbers (also includes inactivated codes since Jan 2008). Last updated: September 3, 2008.
HPO3 NDC Firms NDC firm list.
HPO4 NDC Lookups Codes and decode descriptions used in the official source NDC files.
Dataset Features and Price List
Feature HPO1
$500		 HPO3
FREE		 HPO4
FREE
NDC Code (5-4-2): Each listed drug product is assigned a unique 10-digit, 3-segment NDC number that identifies the labeler, product, and trade package size (Format 5-4-2). X
NDC Code (5-4-1/5-3-2): Each listed drug product is assigned a unique 10-digit, 3-segment NDC number that identifies the labeler, product, and trade package size (Format 5-4-1/5-3-2). X
NDC Code (541/532): Each listed drug product is assigned a unique 10-digit, 3-segment NDC number that identifies the labeler, product, and trade package size (Format 541/532). X
NDC Code (542): Each listed drug product is assigned a unique 10-digit, 3-segment NDC number that identifies the labeler, product, and trade package size (Format 542). X
Product Trade Name: Product name as it appears on the labeling; generally supplied by the manufacturer, with minor editorial changes made by NDC. X
Labeler Code: The Labeler Code is the first segment of the National Drug Code. X X
Product Code: The Product Code is the second segment of the National Drug Code. X
Package Code: The Package Code is the third and last segment of the National Drug Code. X
RX/OTC: Indicates whether product is labeled for RX or OTC use. Other than Insulin products that are OTC, current version of NDC codes do not have any OTC drugs. X
Package Size: The unit or number of units which make up a package. X
Package Type: Package type, i.e., box, bottle, vial, plastic, or glass. X
Active Ingredients: Listing of all the active ingredients and their Strength/UOM. X
Routes of Administration: Routes of administration applicable for the drug. X
Dosage Form: Listing of all the dosage forms applicable for the drug. X
Strength: For single entity products, this is the potency of the active ingredient. For combination products, it may be null or a number or combination of numbers, e.g., Inderide 40/25. X
Unit of Measure: Unit of measure corresponding to strength. This non-mandatory field contains the unit code for a single entity product, e.g., MG, %VV. X
Unit of Measure Description: Unit of measure translation/ name. X
FDA Approved Application Number: Number of New Drug Application if applicable. If none has been provided by the firm then the value ‘Other’ is used. X
Labeler/Firm Name: Firm name as reported by the firm and recorded by NDC. X X
Trade Name Concatenated: Trade Name concatenated by Strength and Unit of Measure in case there is one active ingredient. X
Date Code Effective: Date Code became effective. Blank implies that date is before Q1 2008. X
Date Code Expired: Date of NDC release when code was not found in the list. X
DEA Schedule: Designation for the DEA Schedule. X
Address Header: Address Heading as reported by the Firm. X
Street: Street Address as reported by the Firm. X
PO Box: Post office box number as reported by the Firm. X
City: City of address as reported by the Firm. X
State: US State Name as reported by the Firm. X
Province: Province of Foreign country as reported by the Firm, if applicable. X
Zip: US Zip Code as reported by the Firm. X
Foreign Address: Address information as reported by the Firm for foreign countries that do not fit the U.S. Postal service configuration. X
Country Name: Country of address as reported by the Firm. X
Period ID: Quarter of NDC publication. Derived based on time of snapshot published by NDC. X
Lexicon Code Type: Type of lookup; Route, Dosage forms, Unit of Measure. X
Lexicon Code: Lexicon Code as used by NDC. X
Lexicon Text: Decode/Name for the code. X
Automated Notification: Automated Notification of Changes. X
Free Email Support. X X X
Free Telephone Support. X
Attribute Sources
A list of all attributes of the datasets, along with relevant sources. The field Portal Release Date is the date this information was published on CommonDataHub.
Attribute Source Portal Release Date
NDC Code (5-4-2) NDC 15-Mar-2008
NDC Code (5-4-1/5-3-2) NDC 15-Mar-2008
NDC Code (541/532) NDC 15-Mar-2008
NDC Code (542) NDC 15-Mar-2008
Product Trade Name NDC 15-Mar-2008
Labeler Code NDC 15-Mar-2008
Product Code NDC 15-Mar-2008
Package Code NDC 15-Mar-2008
RX/OTC NDC 15-Mar-2008
Package Size NDC 15-Mar-2008
Package Type NDC 15-Mar-2008
Active Ingredients NDC 15-Mar-2008
Routes of Administration NDC 15-Mar-2008
Dosage Form NDC 15-Mar-2008
Strength NDC 15-Mar-2008
Unit of Measure NDC 15-Mar-2008
Unit of Measure Description NDC 15-Mar-2008
FDA Approved Application Number NDC 15-Mar-2008
Labeler/Firm Name NDC 15-Mar-2008
Trade Name Concatenated NDC 15-Mar-2008
Date Code Effective CDH 15-Mar-2008
Date Code Expired CDH 15-Mar-2008
DEA Schedule NDC 15-Mar-2008
Address Header NDC 15-Mar-2008
Street NDC 15-Mar-2008
PO Box NDC 15-Mar-2008
City NDC 15-Mar-2008
State NDC 15-Mar-2008
Province NDC 15-Mar-2008
Zip NDC 15-Mar-2008
Foreign Address NDC 15-Mar-2008
Country Name NDC 15-Mar-2008
Period ID NDC 15-Mar-2008
Lexicon Code Type NDC 15-Mar-2008
Lexicon Code NDC 15-Mar-2008
Lexicon Text NDC 15-Mar-2008
Details of the sources used:

NDC:
http://www.fda.gov/cder/ndc/

”Each listed drug product listed 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 for a particular firm. The third segment, the package code, identifies package sizes and types. Both the product and package codes are assigned by the firm. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.
An asterisk may appear in either a product code or a package code.  It simply acts as a place holder and indicates the configuration of the NDC.  Since the NDC is limited to 10 digits, a firm with a 5 digit labeler code must choose between a 3 digit product code and 2 digit package code, or a 4 digit  product code and 1 digit package code.
Thus, you have either a 5-4-1 or a 5-3-2 configuration for the three segments of the NDC. Because of a conflict with the HIPAA standard of an 11 digit NDC, many programs will pad the product code or package code segments of the NDC with a leading zero instead of the asterisk. 

Since a zero can be a valid digit in the NDC, this can lead to confusion when trying to reconstitute the NDC back to its FDA standard.  Example: 12345-0678-09 (11 digits) could be 12345-678-09 or 12345-0678-9 depending on the firm's configuration.  By storing the segments as character data and using the * as place holders we eliminate the confusion. In the example, FDA stores the segments as 12345-*678-09 for a 5-3-2 configuration or 12345-0678-*9 for a 5-4-1 configuration.”
Acronyms
A listing of the acronyms and abbreviations used.

DEA: Drug Enforcement Administration
NDC: National Drug Codes
RX: Prescription
OTC: Over-The-Counter
CDH: CommonDataHub
 
Home | About Us | Help | Contact Us | FAQ | Legal | Privacy Policy | Terms of Use v. 20080223.001