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.

All the attributes except Generic Drug Name is extracted from the FDA data feed. Generic Drug Name is derived by commondatahub based on the Active Ingredient(s). Generic Drug Name may be inaccurate or not up-to-date, and must be used as reference only.

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). Please see info page for attribute/source details.
HPO2 NDC Numbers (with enriched attributes) List of active NDC numbers (also includes inactivated codes since 1/2008). Derived attributes. Please see info page for details.
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 Attributes marked with * are either derived attributes or are sourced from authority other than FDA/CDER.
Feature HPO1
$500		 HPO2
$750		 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 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 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 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 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 X
Labeler Code: The Labeler Code is the first segment of the National Drug Code. X X X
Product Code: The Product Code is the second segment of the National Drug Code. X X
Package Code: The Package Code is the third and last segment of the National Drug Code. X 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 X
Package Size: The unit or number of units which make up a package. X X
Package Type: Package type, i.e., box, bottle, vial, plastic, or glass. X X
Active Ingredients: Listing of all the active ingredients and their Strength/UOM. X X
Routes of Administration: Routes of administration applicable for the drug. X X
Dosage Form: Listing of all the dosage forms applicable for the drug. X 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 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 X
Unit of Measure Description: Unit of measure translation/ name. X 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 X
Labeler/Firm Name: Firm name as reported by the firm and recorded by NDC. X X X
Generic Drug Name *: Generic drug name derived based on Active Ingredients. This attribute is derived. It is not an attribute published by FDA . X
Trade Name Concatenated *: Trade Name concatenated by Strength and Unit of Measure in case there is one active ingredient. This attribute is derived X
Date Code Effective *: Date Code became effective. Blank implies that date is before Q1 2008. This is a derived attribute based on the occurrance of a new code in the FDA/CDER source file. X
Date Code Expired *: Date of NDC release when code was not found in the list. This is a derived attributed based on absence of a code in the FDA/CDER source file X X
Change log *: Description of attribute changes if any. X
DEA Schedule: Designation for the DEA Schedule. X X
HCPCS Code *: 5-digit HCPCS Code NDC Code is associated with based on the NCD-HCPCS cross-walk from alternate source listed below. X
HCPCS Relationship Effective Date *: Start date of relationship between NDC and HCPCS Code. X
HCPCS Relationship Expiration Date *: End date of relationship between NDC and HCPCS Code. X
UPC *: UPC Code is formed by placing the U.P.C. Prefix 3 in front of the NDC code and then adding a calculated Check Digit to the end. UPC is not generated for a few codes. 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 X
Lexicon Code Type: Type of lookup; Route, Dosage forms, Unit of Measure. X
Lexicon Code: Lexicon Code as used by NDC. X X
Lexicon Text: Decode/Name for the code. X
Automated Notification: Automated Notification of Changes. X X
Free Email Support. X X X X
Free Telephone Support. X X
Free complete data set browsing. X X X
Free dataset download. X 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) FDA/CDER 15-Mar-2008
NDC Code (5-4-1/5-3-2) CDH {Derived} 15-Mar-2008
NDC Code (541/532) CDH {Derived} 15-Mar-2008
NDC Code (542) CDH {Derived} 15-Mar-2008
UPC CDH + UPC Code Generation Rules {Derived} 8-NOV-2009
Product Trade Name FDA/CDER 15-Mar-2008
Labeler Code FDA/CDER 15-Mar-2008
Product Code FDA/CDER 15-Mar-2008
Package Code FDA/CDER 15-Mar-2008
RX/OTC FDA/CDER 15-Mar-2008
Package Size FDA/CDER 15-Mar-2008
Package Type FDA/CDER 15-Mar-2008
Active Ingredients FDA/CDER 15-Mar-2008
Routes of Administration FDA/CDER 15-Mar-2008
Dosage Form FDA/CDER 15-Mar-2008
Strength FDA/CDER 15-Mar-2008
Unit of Measure FDA/CDER 15-Mar-2008
Unit of Measure Description FDA/CDER 15-Mar-2008
FDA Approved Application Number FDA/CDER 15-Mar-2008
Labeler/Firm Name FDA/CDER 15-Mar-2008
Trade Name Concatenated CDH {Derived} 15-Mar-2008
Date Code Effective CDH {Derived based on existence in the new feed} 15-Mar-2008
Date Code Expired CDH {Derived based on existence or absence in the new feed} 15-Mar-2008
DEA Schedule FDA/CDER 15-Mar-2008
Generic Name CDH {Derived based on active ingredients} 10-Jan-2009
Change Log CDH {Derived by capturing type of change} 21-NOV-2009
HCPCS Code DMECS 29-Jul-2009
HCPCS Relationship Effective Date DMECS 29-Jul-2009
HCPCS Relationship Expiration Date DMECS 29-Jul-2009
Address Header FDA/CDER 15-Mar-2008
Street FDA/CDER 15-Mar-2008
PO Box FDA/CDER 15-Mar-2008
City FDA/CDER 15-Mar-2008
State FDA/CDER 15-Mar-2008
Province FDA/CDER 15-Mar-2008
Zip FDA/CDER 15-Mar-2008
Foreign Address FDA/CDER 15-Mar-2008
Country Name FDA/CDER 15-Mar-2008
Period ID FDA/CDER 15-Mar-2008
Lexicon Code Type FDA/CDER 15-Mar-2008
Lexicon Code FDA/CDER 15-Mar-2008
Lexicon Text FDA/CDER 15-Mar-2008
Details of the sources used:

FDA/CDER:
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.”

DMECS:
https://www.dmepdac.com/crosswalk/index.html

”Official site for HCPCS-NDC crosswalk. DMECS Provides HCPCS coding assistance and national pricing information via searches for HCPCS Level II codes and modifiers, DMEPOS (durable medical equipment, prosthetics, orthotics, and supplies), and CMS national fee schedules. Contains HCPCS codes beginning with the letters A, B, E, J, K, L, Q, and V. Not all of the HCPCS starting with these letters are valid for submission to the DME MACs. Invalid HCPCS are included for convenience. The tracking of coding history and crosswalk information may be incomplete for codes invalid for DME MAC submission.”

CDH:
http://www.commondatahub.com

”Derived attributes are tagged as sourced by CDH.”

UPC Derivation Rules:
http://www.uc-council.org/ean_ucc_system/education_support/cdc.html

”Logic for generating the check digit for UPC codes.”

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
 
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