The FDA has announced a public hearing on 4 approaches to gather comments on proposed changes to the current National Drug Code (NDC). The NDC is a 10- or 11-digit universal product identifier for human drugs in the United States, quickly identifying the labeler (manufacturer, packager) in the first segment, the product (strength, dosage form, formulation) in the second segment, and the package (package size and type) in the third segment (see the image for some examples of codes for Cozaar [branded losartan potassium]. The segments are in one of 3 formats: 4-4-2, 5-4-1, and 5-3-2, and the labeler code (first segment) is the only part assigned by the agency. The problem is the agency will run out of numbers for the 5-digit labeler code (the first segment in formats 5-4-1 and 5-3-2) in the not too distant future, necessitating a change to a new code system. One wonders what happened when they ran out of codes in the 4-digit labeler system!

Before that happens, the agency is collecting information from the public on the pros and cons for 4 proposed changes to the labeler code. Most of these are simply differently timed versions of using 6-digit labeler codes:

Option A: Continue issuing 5-digit codes until they run out, then start issuing 6-digit labeler codes,

Option B: Start issuing 6-digit codes before the 5-digit codes run out,

Option C: Adopt an 11-digit (5-4-2) format already in use by the payer industry, converting all NDCs to this format, and start using 6 digits when the 5 digits run out, or

Option D: Move toward a 6-4-2 (12 digit) format at some future date.

My question is how long did it take to use up the 5-digit labeler codes from the last change, and what’s the current rate of assignment for these codes? Maybe we should skip 6 digits now in favor of 7 to buy ourselves more time.

A full list of the questions the agency seeks to ask, along with instructions on participating may be found here. A searchable version of NDC database is here.

Text and Image Copyright © 2018 Katrina Rogers