National Drug Code Database Background Information
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What are the NDC Number and the National Drug Code Directory?
Section 510 of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. §360, requires a 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. Changes in the Act, resulting from the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA) require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted.
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), which is transforming into the electronic system (eDRLS). The information submitted as part of the listing process, the NDC number, DRLS, eDRLS and the NDC Directory, are used in the implementation and enforcement of the Act.
A registered establishment must update its drug listing data in June and December of each year, to identify drugs not previously listed or when a change occurs (see 21 C.F.R. § 207.30. In some cases FDA may not yet have been notified of recent changes before updating the NDC Directory. FDA makes every effort to prevent errors and discrepancies in the NDC Directory data. Users who detect any errors are requested to contact:
Food and Drug Administration
Office of Compliance
New Hampshire Ave.
Silver Spring, MD 20903
Internet email: edrls@fda.hhs.gov
What products are included in the NDC Directory?
The current edition of the NDC Directory is limited to prescription drugs, OTC drugs, and insulin products that have been manufactured, prepared, propagated, compounded, or processed by registered establishments for commercial distribution. The products have been listed in accordance with the Drug Listing Act and regulatory provisions concerning the submission of drug product information to FDA.
Why are some drug products not in the NDC Directory?
There are a number of reasons why a drug product may not appear in the NDC Directory, such as:
- the product may not be a prescription drug, OTC, or an insulin product
- the firm has notified the FDA that the product is no longer being marketed;
- the firm has not complied fully with its listing obligations and therefore its product is not included until complete information is provided.
THE INCLUSION OF A FIRM OR ITS PRODUCTS IN THE NDC DIRECTORY DOES NOT DENOTE APPROVAL BY THE FDA OF THE FIRM OR ANY OF ITS MARKETED PRODUCTS, NOR IS IT A DETERMINATION THAT A PRODUCT IS A DRUG AS DEFINED BY THE ACT, NOR DOES IT DENOTE THAT A PRODUCT IS COVERED BY OR ELIGIBLE FOR REIMBURSEMENT BY MEDICARE, MEDICAID, OR OTHER PAYERS.
How is the NDC Directory Organized?
1. Product Trade Name or Catalog Name
The product names used in the NDC Directory are generally supplied by the manufacturer (also called “labelers” or “firms” for purposes of listing) as required under the Act. All product names appearing in the NDC Directory are limited to a maximum of 100 characters. Minor editorial changes were made in some cases when 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. But the terms "not NF" and "not USP" may have been left as part of the name. Symbols indicating trademarked or registered products also are omitted because of computer input capabilities. But these deletions are not intended to contradict patent, trademark, registration, or copyright laws or regulations.
2. NDC Number
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.
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.
3. Dosage Form
The complete list of dosage form codes are listed below in the downloadable file TBLDOSAG.TXT
4. Routes of Administration
The complete list of codes for routes of administration are listed below in the downloadable file 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 drug strength is indicated after the active ingredient. For those products with 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, the indicated strength 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 complete list of abbreviations for units and their definitions are in TBLUNIT.TXT.
8. Package Size and Type
The package size and types appear in the NDC Directory as reported by the firm.
9. Major Drug Class
The Major and Minor Drug Class codes are no longer available at this site. FDA plans to review the use of the AMA DRUG Evaluation Subscription classification scheme. This review is necessary because this classification scheme has not been updated since 1976 and therefore many new molecular entities are not included.
10. FDA approved application number
A number in this field is the NDA/ANDA number, which signifies that this product has been approved by FDA for marketing based upon a review of the safety and effectiveness of the drug, including review of 1) whether adequate and well-controlled investigations show that this drug is safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling; 2 ) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of this drug and whether they adequately preserve the drug’s identity, strength, quality, and purity; and 3) the drug’s proposed labeling. For additional information regarding NDA and ANDA approval, see section 505 of the Act, 21 U.S.C. § 355. The FDA Orange Book has additional information on drug products and application holders, which can be accessed using the NDA/ANDA number.
‘OTHER’ in this field signifies that this product may not be approved for both safety and efficacy under an NDA or ANDA, may be subject to the Drug Efficacy Study Implementation (DESI), and/or may be one for which FDA currently lacks sufficient data to provide information. DESI is a retrospective evaluation of the efficacy of drugs that had been approved on safety grounds alone between 1938 and 1962, and drugs identical, related, or similar to those drugs. This evaluation was necessitated by the 1962 amendments to the FD&C Act, which added the requirement that a drug be evaluated for efficacy, not only for safety, for FDA approval.
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,
New Hampshire Ave.
Silver Spring, MD 20903
Telephone: (301) 827-6500 FAX: (301)443-1726
The Internet NDC Directory contains the following information, which is updated at least quarterly:
(Files can be imported into most databases using ASCII file import)
| Filename | Description |
| tbldosag.txt tblroute.txt tblunit.txt |
The Directory contains 3 tables that list descriptors and codes describing the data. They are: Dosage Forms, Routes of administration, and Unit Codes. |
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The 11 data files contain the product and firm data. The files have one or both linking elements: LISTING_SEQ_NO NOT NULL NUM(7) LBLCODE NOT NULL NUM(7) |
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| Filename | Description |
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1. LISTINGS DATA [LISTINGS.TXT]
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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(7) COL: 1-7 LBLCODE NOT NULL CHAR(6) COL: 9-14 PRODCODE NOT NULL CHAR(4) COL: 16-19 STRENGTH NULL CHAR(10) COL: 21-30 UNIT NULL CHAR(10) COL: 32-41 RX_OTC NOT NULL CHAR(1) COL: 43 TRADENAME NOT NULL CHAR(100) COL: 45-144
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2. PACKAGES DATA [PACKAGES.TXT]
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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 one or two digit segment of the NDC. LISTING_SEQ_NO NOT NULL NUM(7) COL: 1-7 PKGCODE NULL CHAR(2) COL: 9-10 PACKSIZE NOT NULL CHAR(25) COL: 12-36 PACKTYPE NOT NULL CHAR(25) COL: 38-62 |
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3. FORMULATIONS DATA [FORMULAT.TXT]
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MAY OCCUR MULTIPLE TIMES PER LISTING SEQ NO. Lists active ingredients contained in product's formulation. LISTING_SEQ_NO NOT NULL NUM(7) COL: 1-7 STRENGTH NULL CHAR(10) COL: 9-18 UNIT NULL CHAR(5) COL: 20-24 INGREDIENT_NAME NOT NULL CHAR(100) COL: 26-125 |
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4. NEW DRUG APPLICATION DATA [APPLICAT.TXT]
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MAY OCCUR MORE THAN ONCE PER LISTING SEQ NO. LISTING_SEQ_NO NOT NULL NUM(7) COL:1-7 APPL_NO NULL CHAR(6) COL:9-14 PROD_NO NULL CHAR(3) COL:16-18 |
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5. FIRM NAME DATA [FIRMS.TXT]
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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. LBLCODE NOT NULL NUM(6) COL:1-6 FIRM_NAME NOT NULL CHAR(65) COL:8-72 ADDR_HEADER NULL CHAR(40) COL:74-113 STREET NULL CHAR(40) COL:115-154 PO_BOX NULL CHAR(9) COL:156-164 FOREIGN_ADDR NULL CHAR(40) COL:166-205 CITY NULL CHAR(30) COL:207-236 STATE NULL CHAR(2) COL:238-239 ZIP NULL CHAR(9) COL:241-249 PROVINCE NULL CHAR(30) COL:251-280 COUNTRY_NAME NOT NULL CHAR(40) COL:282-321 |
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6. ROUTE OF ADMINISTRATION DATA [ROUTES.TXT]
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LISTING_SEQ_NO NOT NULL NUM(7) COL:1-7 ROUTE_CODE NULL CHAR(3) COL:9-11 ROUTE_NAME NULL CHAR(240) COL:13-252 |
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7. DOSAGE FORM [DOSEFORM.TXT] |
MAY OCCUR MULTIPLE TIMES PER LISTING SEQ NO. LISTING_SEQ_NO NOT NULL NUM(7) COL:1-7 DOSEFORM NULL CHAR(3) COL:9-11 DOSAGE_NAME NULL CHAR(240) COL:13-252 |
| 8. TBLDOSAG.TXT |
THIS FILE CONTAINS A COMPLETE LIST OF THE DOSAGEFORM CODES USED IN THE DIRECTORY DOSEFORM CHAR(3) COL:1-3 The code for the dosage form.
TRANSLATION CHAR(100) COL:5-104 |
| 9. TBLROUTE.TXT |
THIS FILE CONTAINS A COMPLETE LIST OF THE ROUTE CODES USED IN THE DIRECTORY ROUTE CHAR(3) COL:1-3 The code for the ROUTE OF ADMINISTRATION.
TRANSLATION CHAR(100) COL:5-104 |
| 10. TBLUNIT.txt |
THIS FILE CONTAINS A COMPLETE LIST OF THE POTENCY UNIT ABBREVIATIONS USED IN THE DIRECTORY. UNIT CHAR(15) COL:1-15 The potency unit abbreviations used in the directory.
TRANSLATION CHAR(100) COL:17-115 |
| 11. REG_SITES.txt |
This file contains a list of all currently active and registered domestic manufacturing facilities. UNLIKE THE FILES ABOVE, IT IS A TAB DELIMITED FILE, WITH THE FIRST LINE CONTAINING THE COLUMN HEADERS. The data elements are: FEI: Unique ID number LAST_REG_YEAR: Last year the annual registration obligation was fulfilled. Some older, inactive sites may be on the list. The records need to be updated by the firm and/or FDA. NAME: Registered firm name STREET: street address CITY: name of city STATE: name of state ISO_COUNTRY_CODE: identifies the country. Currently only U.S. sites are included. COUNTRY_NAME: translation of country code. |
| 12. SCHEDULE.txt |
This file identifies those listed products in the directory which have a DEA schedule designation. LISTING_SEQ_NO NOT NULL NUM(7) COL:1-7 Linking field to LISTINGS. SCHEDULE NOT NULL NUM(1) COL:9 |
| 13. ZIPPED NDC DIRECTORY DATA |
NDC text data files
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