Labeler Code

Key facts

Assigned by

U.S. Food and Drug Administration (FDA)

Position

First segment of the NDC

Current length

4 or 5 digits

NDC formats

4-4-2, 5-3-2 or 5-4-1, padded to 11 digits for billing

Assigned to

Manufacturers, repackagers, relabelers and private label distributors

What is a labeler code?

Every National Drug Code has three segments: labeler, product and package. The labeler code identifies the company whose label is on the package. A firm requests a labeler code from the FDA before listing its drugs, then assigns its own product and package codes within that labeler code.

The labeler is not always the manufacturer. A repackager or private label distributor that sells a drug under its own name gets its own labeler code, so the same tablet can carry several NDCs with different labeler codes.

How labeler codes fit the NDC format

NDCs are 10 digits in one of three layouts: 4-4-2, 5-3-2 or 5-4-1. Billing systems, including Medicaid and Medicare Part B, use an 11-digit 5-4-2 format created by adding a leading zero to the shorter segment.

Because the supply of 5-digit labeler codes is running out, the FDA has proposed moving to a longer uniform NDC format with 6-digit labeler codes. Systems that parse NDCs by fixed positions will need to handle that change.

Why labeler codes matter

Labeler codes let analysts group drug data by company. Recalls, pricing files, rebate agreements and listings can all be rolled up by labeler. In the Medicaid Drug Rebate Program, rebate agreements are signed at the labeler level, so a manufacturer with several labeler codes covers each one.

The catch is that one company can hold many labeler codes, through acquisitions or separate subsidiaries, and a labeler code can move between companies after a sale. Mapping labeler codes to parent companies needs a maintained crosswalk.