National Drug Code
Encyclopedia
The National Drug Code is a unique product identifier used in the United States
for drugs intended for human
use. 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. Drug products are identified and reported using the NDC.
listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identifies the labeler or vendor, product (within the scope of the labeler), and trade package (of this product).
While the labeler code is assigned by the FDA, both the product and package segments are assigned by the labeler. While in the past labelers may have had the opportunity to re-assign old product codes no longer used to new products, according to the new FDA validation procedures, once an NDC code is assigned to one product (defined by key properties including active ingredients, strength, and dosage form) it may not be later reassigned to a different product.
NDC codes exist in one of the following groupings of digits into segments: 4-4-2, 5-3-2, or 5-4-1, but all NDC codes have 10 digits.
The official FDA format for NDCs separates the 3 segments with dashes. This is the format in which the NDC must be submitted by labelers since mandatory electronic listing was established in June 2009.
The previous NDC directory, populated by a paper-based listing system, sometimes inserted an asterisk
in either a product code or a package code in addition to the dashes. This format is easily transformed to the official format in effect today by deleting the asterisk (if any).
Each NDC-coded product package in the US bears a barcode
with a Universal Product Code
that begins with a 3 (UPC-A) or 03 (EAN-13). The remainder of the numbers are the 10 NDC digits, plus the check digit
. This is the most minimal form of the NDC code with 10 digits only. Because the NDC code has been linked with product barcodes in this way, the NDC code could contain ambiguities in this form. For example, 1234-5678-90, 12345-678-90, and 12345-6789-0 could all be entirely different products with the same barcode 1234567890. To prevent any actual ambiguity from impacting the marketplace, ambiguity checks are part of the new electronic listing process.
The pure 10-digit NDC format cannot be transformed back into the standard format with dashes without the help of the product listing database.
The Centers for Medicare and Medicaid Services
(CMS) had created an 11-digit NDC derivative, which pads the product code or package code segments of the NDC with a leading zero thus resulting in a fixed length 5-4-2 configuration (but always written without dashes). This format was adopted by data standards selected pursuant to HIPAA regulation, thus other government agencies' lists and databases (such as the UMLS) may contain the 11-digit derivative of the original NDC.
The 11-digit NDC format cannot be transformed back into the 10-digit standard format without the help of the product listing database.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
for drugs intended for human
Human
Humans are the only living species in the Homo genus...
use. The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. Drug products are identified and reported using the NDC.
National Drug Code format
The National Drug Code is a unique 10-digit, 3-segment numeric identifier assigned to each medicationMedication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identifies the labeler or vendor, product (within the scope of the labeler), and trade package (of this product).
- The first segment, the labeler code, is 4 or 5 digits long and assigned by the Food and Drug AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) upon submission of a Labeler Code Request. A labeler is any firm that manufactures, repacks or distributes a drug product. - The second segment, the product code, is 3 or 4 digits long and identifies a specific strength, dosage form, and formulation for a particular firm.
- The third segment, the package code, is 1 or 2 digits long and identifies package forms and sizes. In very exceptional cases, product and package segments may have contained characters other than digits.
While the labeler code is assigned by the FDA, both the product and package segments are assigned by the labeler. While in the past labelers may have had the opportunity to re-assign old product codes no longer used to new products, according to the new FDA validation procedures, once an NDC code is assigned to one product (defined by key properties including active ingredients, strength, and dosage form) it may not be later reassigned to a different product.
NDC codes exist in one of the following groupings of digits into segments: 4-4-2, 5-3-2, or 5-4-1, but all NDC codes have 10 digits.
The official FDA format for NDCs separates the 3 segments with dashes. This is the format in which the NDC must be submitted by labelers since mandatory electronic listing was established in June 2009.
Variant formats
While the NDC is a 10-digit identifier, confusion exists because of a proliferation of different notations and variants.The previous NDC directory, populated by a paper-based listing system, sometimes inserted an asterisk
Asterisk
An asterisk is a typographical symbol or glyph. It is so called because it resembles a conventional image of a star. Computer scientists and mathematicians often pronounce it as star...
in either a product code or a package code in addition to the dashes. This format is easily transformed to the official format in effect today by deleting the asterisk (if any).
Each NDC-coded product package in the US bears a barcode
Barcode
A barcode is an optical machine-readable representation of data, which shows data about the object to which it attaches. Originally barcodes represented data by varying the widths and spacings of parallel lines, and may be referred to as linear or 1 dimensional . Later they evolved into rectangles,...
with a Universal Product Code
Universal Product Code
The Universal Product Code is a barcode symbology , that is widely used in North America, and in countries including the UK, Australia, and New Zealand for tracking trade items in stores. Its most common form, the UPC-A, consists of 12 numerical digits, which are uniquely assigned to each trade item...
that begins with a 3 (UPC-A) or 03 (EAN-13). The remainder of the numbers are the 10 NDC digits, plus the check digit
Check digit
A check digit is a form of redundancy check used for error detection, the decimal equivalent of a binary checksum. It consists of a single digit computed from the other digits in the message....
. This is the most minimal form of the NDC code with 10 digits only. Because the NDC code has been linked with product barcodes in this way, the NDC code could contain ambiguities in this form. For example, 1234-5678-90, 12345-678-90, and 12345-6789-0 could all be entirely different products with the same barcode 1234567890. To prevent any actual ambiguity from impacting the marketplace, ambiguity checks are part of the new electronic listing process.
The pure 10-digit NDC format cannot be transformed back into the standard format with dashes without the help of the product listing database.
The Centers for Medicare and Medicaid Services
Centers for Medicare and Medicaid Services
The Centers for Medicare & Medicaid Services , previously known as the Health Care Financing Administration , is a federal agency within the United States Department of Health and Human Services that administers the Medicare program and works in partnership with state governments to administer...
(CMS) had created an 11-digit NDC derivative, which pads the product code or package code segments of the NDC with a leading zero thus resulting in a fixed length 5-4-2 configuration (but always written without dashes). This format was adopted by data standards selected pursuant to HIPAA regulation, thus other government agencies' lists and databases (such as the UMLS) may contain the 11-digit derivative of the original NDC.
The 11-digit NDC format cannot be transformed back into the 10-digit standard format without the help of the product listing database.