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The National Drug Code Directory
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NDC]
[Data Files Updated through 1/13/2009]
What are the NDC Number and the
National Drug Code Directory?
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 information submitted as part of the listing process, the NDC number, DRLS, and the NDC Directory are used in the implementation and enforcement of the Act.
The
DRLS Instruction
Booklet describes in detail the registration and listing processes and also contains applicable provisions of the Code of Federal Regulations (CFR). These regulations require a registered establishment to update its drug listing data in June and December of each year, or, at the discretion of the establishment, when a change occurs (see 21 C.F.R. § 207.30); therefore, 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
Division of Compliance Risk Management and Surveillance (DRLS)
(HFD-330)
5600 Fishers Lane
Rockville, Maryland 20857
Internet email: drls@fda.hhs.gov
Phone: 301-210-2840
FAX: 301-210-2849
What products are included 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. 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 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.
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.
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 (http://www.fda.gov/cder/orange)
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, 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 at least quarterly:
(Files can be imported into most databases using ASCII file
import)
National Drug Code Directory Support Files
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Filename
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Description
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tbldosag.txt
tblroute.txt
tblunit.txt
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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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National Drug Code Directory ASCII Data Files |
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)
FDA generated unique identification number for each product. Only used in information systems to link tables together; not used publicly.
LBLCODE NOT NULL NUM(7)
FDA generated identification number for each firm. Used as the first segment in
the NDC and can be used to link tables together based on Firm. |
Filename |
Description |
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
FDA generated unique identification number for each product.
LBLCODE NOT NULL CHAR(6) COL: 9-14
Labeler code portion of NDC; assigned by FDA to firm. The labeler code is the first segment of the National Drug Code. While always displayed as 6 digits in this file; for labeler codes 2 through 9999, some systems display it as 4 digits; for labeler codes 10,000 through 99,999 it is 5 digits. Can be used to link to the FIRMS.TXT file to obtain firm name.
PRODCODE NOT NULL CHAR(4) COL: 16-19
Product code assigned by firm. The prodcode is the second segment of the National Drug Code. It may be a 3-digit or 4-digit code depending upon the NDC configuration selected by the firm.
STRENGTH NULL CHAR(10) COL: 21-30
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) COL: 32-41
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) COL: 43
Indicates whether product is labeled for Rx or OTC use (R/O).
TRADENAME NOT NULL CHAR(100) COL: 45-144
Product's name as it appears on the labeling.
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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
Linking field to LISTINGS.
PKGCODE NULL CHAR(2) COL: 9-10
The package code portion of NDC code. The package code is the last segment of the NDC.
PACKSIZE NOT NULL CHAR(25) COL: 12-36
The unit or number of units which make up a package.
PACKTYPE NOT NULL CHAR(25) COL: 38-62
Package type, i.e., box, bottle, vial, plastic, or glass. |
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
Linking field to LISTINGS.
STRENGTH NULL CHAR(10) COL: 9-18
This is the potency of the active ingredient.
UNIT NULL CHAR(5) COL: 20-24
Unit of measure corresponding to strength.
INGREDIENT_NAME NOT NULL CHAR(100) COL: 26-125
Truncated preferred term for the active ingredient. |
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
Linking field to LISTINGS.
APPL_NO NULL CHAR(6) COL:9-14
Number of New Drug Application if applicable. If none has been provided by the firm then the value ‘Other’ is used.
PROD_NO NULL CHAR(3) COL:16-18
Number used to identify the products of a New Drug Application. |
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
FDA generated identification number for each firm. The number is padded to the
left with zeroes to fill out to length 6.
FIRM_NAME NOT
NULL CHAR(65) COL:8-72
Firm name as reported by the firm.
ADDR_HEADER
NULL CHAR(40) COL:74-113
Address Heading as reported by the firm.
STREET NULL
CHAR(40) COL:115-154
Street Address as reported by firm.
PO_BOX NULL
CHAR(9) COL:156-164
Post office box number as reported by firm.
FOREIGN_ADDR
NULL CHAR(40) COL:166-205
Address information report by firm for foreign countries that does not fit the
U.S. Postal service configuration.
CITY NULL
CHAR(30) COL:207-236
STATE NULL
CHAR(2) COL:238-239
ZIP NULL
CHAR(9) COL:241-249
USPS Zip code.
PROVINCE NULL
CHAR(30) COL:251-280
Province of Foreign
country if appropriate.
COUNTRY_NAME NOT NULL CHAR(40) COL:282-321 |
6. ROUTE OF ADMINISTRATION DATA [ROUTES.TXT]
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LISTING_SEQ_NO NOT NULL NUM(7)
COL:1-7
Linking field to LISTINGS.
ROUTE_CODE NULL CHAR(3)
COL:9-11
The code for the route of administration. File will allow all assigned values for this element.
ROUTE_NAME NULL CHAR(240)
COL:13-252
The translation for the route of administration code. |
7. DOSAGE FORM
[DOSEFORM.TXT] |
MAY OCCUR MULTIPLE TIMES PER LISTING SEQ NO.
LISTING_SEQ_NO NOT NULL NUM(7)
COL:1-7
Linking field to LISTINGS.
DOSEFORM NULL CHAR(3)
COL:9-11
The code for the route of administration. File will allow all assigned values for this element.
DOSAGE_NAME NULL CHAR(240)
COL:13-252
The translation for the route of administration code. |
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
The translation for the DOSAGE FORM code. |
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
The translation for the ROUTE code. |
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
The translation for the UNIT abbreviations. |
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 [ZIPTEXT.EXE] 4.2 MB (self-extracting)
or
[ZIPTEXT.ZIP] 4.2 MB |
The 7 NDC text data files and 3 tables zipped into 1 file.
(Approximately 68 Megabytes in self extracting file) |
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Date updated: January 16, 2009 |
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