National Drug Code

The National Drug Code (NDC) 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.

National Drug Code format

The National Drug Code is a unique 10-digit, 3-segment numeric identifier assigned to each medication listed under Section 510 of the U.S. 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 Administration (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 segment, is 3 or 4 digits long and identifies a specific strength, dosage form, and formulation for a particular firm.
• The third segment, the package segment, is 1 or 2 digits long and identifies package forms and sizes. In very exceptional cases, product and package segments 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 no longer used product codes 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 can not be later re-assigned to a different product.

While the first segment is called the labeler code, the other segments are called segment, and not code. The NDC package code is the full 3 segment code, while the NDC product code refers to the combination of labeler code and product segment. Thus, the 2-segment NDC product code identifies a product uniquely, while the full 3-segment NDC code identifies a packaged product. Without further qualification, "NDC code" refers to the full 3-segment packaged 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 of 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 which was 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, simply 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 digit 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 can not 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, hence other government agencies may use, and databases (such as the UMLS) may contain the 11-digit derivative of the original NDC.

The 11-digit NDC format can not be transformed back into the 10-digit standard format without the help of the product listing database.

External links

• about the National Drug Code Directory
• the National Drug Code Directory Search entry page
• NDC data searchable on many fieldsfa:نظام‌نامه دارویی بین‌الملل

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/UCM070829

SPL Validation Procedures

Guidance for Industry - Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing