The National Drug Code Directory

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[Data Files Updated through 9/30/2004]

Frequently Asked Questions about The National Drug Code Directory

INTERNET NDC DIRECTORY

The NDC System was originally established as an essential part of an out-of-hospital drug reimbursement program under Medicare. The NDC serves as a universal product identifier for human drugs. The current edition of the National Drug Code Directory is limited to prescription drugs and a few selected OTC products.

Every effort has been made to prevent errors and discrepancies in the NDCD data. Users who detect any errors are requested to contact:

Food and Drug Administration
Information Management Team HFD-143
5600 Fishers Lane
Rockville, Maryland 20857
Internet email: DRLS@CDER.FDA.GOV

Phone: 301-210-2840
FAX: 301-210-2849

THE INCLUSION OF A FIRM OR ITS PRODUCTS IN THE NATIONAL DRUG CODE DIRECTORY DOES NOT IN ANY WAY DENOTE APPROVAL BY THE U.S. FOOD AND DRUG ADMINISTRATION OF THE FIRM OR ANY OF ITS MARKETED PRODUCTS.

ORGANIZATION OF THE DIRECTORY

1. Product Trade Name or Catalog Name

The product names used in the Directory are generally those supplied by the labelers (firms) as required under the Food, Drug, and Cosmetic Act. All product names appearing in this Directory have been limited to a maximum of 100 characters. Minor editorial changes were made in some instances where information normally included with the name appears elsewhere in the product description. For example, where strength is ordinarily listed as a component of the product name, but also appears in other data fields, the strength may have been removed from the product name. The designations, "United States Pharmacopeia" (USP) or "National Formulary" (NF) may also have been deleted from product names. Occasionally, however, the term "not NF" and "not USP" have been left as part of the name. Symbols indicating trademarked or registered products also had to be omitted because of computer input capabilities. These deletions are not intended in any way to deprive the labeler of the protection afforded to him under patent, trademark, registration, or copyright laws or regulations.

2. National Drug Code (NDC)

Each drug product listed under Section 510 of the Federal Food, Drug, and Cosmetic Act is assigned a unique 10-digit, 3-segment number. This number, known as the National Drug Code (NDC), identifies the labeler/vendor, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures, repacks or distributes a drug product. 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. 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.

3. Dosage Form

The dosage form abbreviations are listed in TBLDOSAG.TXT.

4. Routes of Administration

The routes of administration abbreviations are listed in TBLROUTE.TXT.

5. Active Ingredient(s)

The active ingredients are listed in a separate file FORMULAT.TXT which is linked to LISTINGS.TXT via the LISTINGS_SEQ_NO field in each file.

6. Strength

The strength is indicated after the active ingredient. For those products which have equivalent ingredients the strength expressed is that of the equivalent. For some combination products, the strength is that which is commonly recognized for that formulation. The product itself also has a strength/unit. For products with a single active ingredient it is the strength of that active ingredient. For multiple active ingredient products, the strength is either "COMBO" or a concatenation of the multiple strengths.

7. Unit

The abbreviations for units and their definitions are in TBLUNIT.TXT.

8. Package Size and Type

The package size and types appear in the Directory as reported by the firm.

9. Major Drug Class

The major drug class is a general therapeutic or pharmacological classification scheme for drug products reported to the FDA under the provisions of the Drug Listing Act. The classification scheme used was based on the AMA DRUG EVALUATIONS SUBSCRIPTION and generally follows the organization of material in that publication. The drug class for each product was determined by the labeled indication. The major (ending with "00") and minor drug class codes and their definitions are listed in TBLDCLAS.TXT.

Requests for more specific information should be submitted in writing or directed to FDA's Freedom of Information Staff at:

Food and Drug Administration
Freedom of Information Office, HFI-35
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301)827-6500 FAX: (301)443-1726

The Internet NDC Directory contains the following information, which is updated quarterly:

(Files can be imported into most databases using ASCII file import)

National Drug Code Directory Support Files
Filename	Description
PREFACE.TXT	The preface of the NDC Directory in ASCII format that describes the Directory background and content.
tbldclas.txt tbldosag.txt tblroute.txt tblunit.txt	The Directory contains 4 tables that list descriptors and codes describing the data. They are: Dosage Forms, Routes of administration, Unit Codes, and Drug Class.

National Drug Code Directory ASCII Data Files
The 7 data files contain the product and firm data. The files have one or both linking elements: LISTING_SEQ_NO NOT NULL NUM(10) FDA generated unique identification number for each product. Only used in information systems to link tables together; not used publicly. FIRM_SEQ_NO NOT NULL NUM(7) FDA generated unique identification number for each firm. Only used in information systems to link tables together; not used publicly.
Filename	Description
1. LISTINGS DATA [LISTINGS.TXT] 173 Characters Per Record	EACH PRODUCT HAS A UNIQUE LISTING SEQ NO; EACH FIRM SEQ NO CAN HAVE MULTIPLE LISTING SEQ NO'S. Each line in this file represents a product for an individual firm. The listing includes such information as the product's name, firm's seq number, dose form(s), and Rx/OTC. LISTING_SEQ_NO NOT NULL NUM(10) FDA generated unique identification number for each product. LBLCODE NOT NULL CHAR(6) Labeler code portion of NDC; assigned by FDA to firm. The labeler code is the first segment of the National Drug Code (NDC). For labeler codes 2 through 9999, it is 4 digits; for labeler codes 10,000 through 99,999 it is 5 digits. PRODCODE NOT NULL CHAR(4) Product code assigned by firm. The prodcode is the second segment of the National Drug Code (NDC). It may be a 3-digit or 4-digit code depending upon the NDC configuration selected by the firm. STRENGTH NULL CHAR(10) 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. UNIT NULL CHAR(10) Unit of measure corresponding to strength. This non-mandatory field contains the unit code for a single entity product, e.g., MG, %VV. RX_OTC NOT NULL CHAR(1) Indicates whether product is labeled for Rx or OTC use (R/O). DOSAGE_FORM NULL CHAR(25) An abbreviation for the product dosage form. File will allow up to two values for this element, to accommodate multiple-part products. FIRM_SEQ_NO NOT NULL NUM(7) FDA generated unique identification number for each firm. Links to file FIRMS.TXT. TRADENAME NOT NULL CHAR(100) Product's name as it appears on the labeling.
2. PACKAGES DATA [PACKAGES.TXT] 65 Characters Per Record	MAY OCCUR MULTIPLE TIMES PER LISTING SEQ NO Stores packages for an individual listing. The packages table includes all packages for a corresponding listing. The PKGCODE field contains the last two digit segment of the NDC. LISTING_SEQ_NO NOT NULL NUM(10) Linking field to LISTINGS. PKGCODE NULL CHAR(2) The package code portion of NDC code. The package code is the last segment of the NDC. PACKSIZE NOT NULL CHAR(25) The unit or number of units which make up a package. PACKTYPE NOT NULL CHAR(28) Package type, i.e., box, bottle, vial.
3. FORMULATIONS DATA [FORMULAT.TXT] 130 Characters Per Record	MAY OCCUR MULTIPLE TIMES PER LISTING SEQ NO. Lists active ingredients contained in product's formulation. LISTING_SEQ_NO NOT NULL NUM(10) Linking field to LISTINGS. STRENGTH NULL CHAR(10) This is the potency of the active ingredient. UNIT NULL CHAR(5) Unit of measure corresponding to strength. INGREDIENT_NAME NOT NULL CHAR(105) Truncated preferred term for the active ingredient.
4. DRUG CLASS DATA [DRUGCLAS.TXT] 66 Characters Per Record	MAY OCCUR MULTIPLE TIMES PER LISTING SEQ NO. LISTING_SEQ_NO NOT NULL NUM(10) Linking field to LISTINGS. PRODUCT_CLASS_NO NULL CHAR(4) This field contains one or more drug class assigned to a product. DRUG_CLASSIFICATION NULL CHAR(52) Translation of drug class code above. Drug group derived by FDA based on organization of material in AMA Drug Evaluations (edition 3).
5. NEW DRUG APPLICATION DATA [APPLICAT.TXT] 19 Characters Per Record	MAY OCCUR ZERO OR ONCE PER LISTING SEQ NO. LISTING_SEQ_NO NOT NULL NUM(10) Linking field to LISTINGS. APPL_NO NULL CHAR(6) Number of New Drug Application if applicable. PROD_NO NULL CHAR(3) Number used to identify the products of a New Drug Application.
6. FIRM NAME DATA [FIRMS.TXT] 343 Characters Per Record	EACH FIRM HAS A UNIQUE FIRM SEQ NO WHICH CAN OCCUR MULTIPLE TIMES IN THE LISTINGS FILE. Contains the firm's full name, and compliance address. The compliance address is the mailing address where the FDA sends listing information to the firm for review once a year. FIRM_SEQ_NO NOT NULL NUM(7) FDA generated unique identification number for each firm. LBLCODE NOT NULL CHAR(6) FIRM_NAME NOT NULL CHAR(65) ADDR_HEADER NULL CHAR(65) STREET NULL CHAR(40) PO_BOX NULL CHAR(9) FOREIGN_ADDR NULL CHAR(40) CITY NULL CHAR(30) STATE NULL CHAR(2) PROVINCE NULL CHAR(30) ZIP NULL CHAR(9) COUNTRY_NAME NOT NULL CHAR(40)
7. ROUTE OF ADMINISTRATION DATA [ROUTES.TXT] 41 Characters Per Record	LISTING_SEQ_NO NOT NULL NUM(10) Linking field to LISTINGS. ROUTE_CODE NULL CHAR(3) The code for the route of administration. File will allow all assigned values for this element. ROUTE_NAME NULL CHAR(28) The translation for the route of administration code.
8. ZIPPED NDC DIRECTORY DATA [ZIPTEXT.EXE] 1.8 MB or [ZIPTEXT.ZIP]	The 7 NDC text data files and 4 tables zipped into 1 file. (Approximately 15.9 Megabytes in self extracting file)

Date updated: October 7, 2004