Datasets / NDC Directory — National Drug Code

Background

What an NDC is, in ten digits and in eleven

Title 21 of the Code of Federal Regulations (CFR), section 207.33, requires each finished drug product or unfinished drug subject to listing to have a unique NDC identifying its labeler, product, and package size and type.^[3] The first segment of an NDC, the labeler code, is assigned by the FDA, and a labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug.^[4]

The NDC the FDA currently assigns to each listed drug marketed in the U.S. is a unique 10-digit number and can be in several different formats.^[5] A 10-digit NDC is in one of three configurations of segment lengths: 4-4-2, 5-3-2 or 5-4-1.^[4] In the FDA's NDC Directory files, a package's NDC is written as its labeler code, product code and package code segments separated by hyphens.^[6]

The Centers for Medicare and Medicaid Services created an 11-digit NDC derivative that pads the labeler, product or package segment with leading zeros to a fixed 5-4-2 configuration, always written without dashes.^[7] The 11-digit NDC format used for reimbursement is a standard under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).^[5][8] In the National Library of Medicine's examples of normalising NDCs to the 11-digit form, 0591-0933-01 becomes 00591093301 and 60951-700-85 becomes 60951070085.^[9] An 11-digit NDC cannot be transformed back into the 10-digit standard format without the help of a product listing database.^[7] Meridian's code column holds the 11-digit form at every level: five digits for a labeler, nine for a product and eleven for a package, each a prefix of the codes under it.^[2] Meridian's code_display column holds the FDA's hyphenated form.^[2]

Who uses it

Meridian's package rows carry their product's fields, so a join on a package NDC gets the product's names, ingredients and classes on the same row.^[2] An 11-digit NDC can be turned into a nine-digit product code by removing the last two digits, which does not work reliably for 10-digit NDCs where the package code might be one digit.^[7] Meridian's parent_code column gives a package's product as its first nine digits and a product's labeler as its first five.^[10]

Assignment of an NDC number does not in any way denote FDA approval of the product.^[1] Inclusion in the NDC Directory does not mean a product is covered or eligible for reimbursement by Medicare, Medicaid or other payers.^[1] The NDC Directory does not include animal drugs, blood products, drugs manufactured under contract or drugs marketed solely as part of a kit, combination product or inner layer of a multi-level packaged product not marketed individually.^[1] Products with an end marketing date are removed from the NDC Directory when that date is reached.^[11] Expect some NDCs in older claims and records to find no row in the current directory. (Meridian's view) The content of each NDC Directory entry is the responsibility of the labeler submitting it.^[1] The FDA does not submit or alter registration or listing data.^[1] Read brand names, ingredients and package descriptions as each labeler's own wording, not as text the FDA has checked. (Meridian's view)

What we found building it

Meridian reads openFDA's JSON file, which is UTF-8, where the FDA's own text files are Windows-1252.^[2] openFDA's download also holds unfinished drugs, whose listings reuse product NDCs across firms, so Meridian reads only the listings marked finished.^[2]

Labelers submit their names with each listing, and one labeler code's listings can spell the name more than one way, so Meridian's labeler row takes the name given most often.^[2] A product NDC can have more than one listing, one per labeling document, and Meridian's product row takes its fields from the listing certified latest.^[2] Meridian's build fails if two different NDCs pad to the same 11-digit code.^[2]

Where it comes from

The Drug Listing Act of 1972 requires registered drug establishments to provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution.^[4] The NDC Directory's previous version included only listed human prescription drugs and insulin products, and excluded many products, including over-the-counter (OTC) products.^[4] The NDC Directory's new edition includes electronically listed human prescription and OTC drugs manufactured, prepared, propagated, compounded or processed by registered establishments for commercial distribution.^[4] Labelers have had to submit NDCs in the FDA's official hyphenated format since mandatory electronic listing was established in June 2009.^[7] The FDA's NDC Directory files no longer use asterisks within the product and package code segments to indicate certain configurations of the NDC.^[6] The FDA updates the NDC Directory daily.^[1] Unless otherwise noted, data on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.^[12] CC0 in no way affects the patent or trademark rights of any person.^[12]

In 2022, the FDA proposed requiring a uniform 12-digit NDC with the same three segments but uniform segment lengths of 6, 4 and 2 digits.^[7] The FDA's final rule, Revising the National Drug Code Format and Drug Label Barcode Requirements, adopts a uniform 12-digit NDC format and takes effect March 7, 2033.^[1] The FDA's 12-digit rule affects only FDA-assigned NDCs, and makes no changes to NDC formats used for purposes unrelated to the FDA, such as the HIPAA standard 11-digit format used for reimbursement.^[5] Companies are to move their labels to the 12-digit format by adding leading zeros to the labeler code, product code or package code segments as needed.^[5] From March 7, 2033 through March 6, 2036 the FDA does not intend to object to continued use of 10-digit NDCs on drug labels.^[5]

Sources

1. [1]National Drug Code Directorydocumentation
2. [2]README.mdMeridian's method docs
3. [3]eCFR :: 21 CFR 207.33 -- What is the National Drug Code (NDC), how is it assigned, and what are its requirements?standard
4. [4]National Drug Code Directory (NDC)documentation
5. [5]National Drug Code Formatdocumentation
6. [6]NDC Package File Definitionsdocumentation
7. [7]National drug codesecondary source
8. [8]Health Insurance Portability and Accountability Actsecondary source
9. [9]RxNorm Technical Documentationdocumentation
10. [10]datapackage.jsonMeridian's method docs
11. [11]NDC Product File Definitionsdocumentation
12. [12]Data Licensingdocumentation