Segment 1 — the labeler code
Four or five digits, assigned by the FDA. It identifies whoever is legally responsible for the label, which need not be the manufacturer: repackagers, relabelers and private-label distributors all hold their own labeler codes.
Codes are issued in sequence and never reused, so a low labeler code usually signals an old company and an old code still resolves to a name even after the firm is gone.
Segment 2 — the product code
Three or four digits, assigned by the labeler rather than the FDA, and unique only within that labeler's range. It identifies one specific formulation: a strength in a dosage form.
Change the strength, the dosage form or the formulation and you need a new product code. Change only the box size and you do not.
Segment 3 — the package code
One or two digits identifying the commercial package: a bottle of 30, a bottle of 90, a carton of five vials. This is the segment that appears on the outer carton barcode and the one payers price against.
The three 10-digit shapes
| Format | Example | Which segment is short |
|---|---|---|
| 4-4-2 | 0002-7510-01 | Labeler — four digits |
| 5-3-2 | 50242-051-01 | Product — three digits |
| 5-4-1 | 0169-4132-1 | Package — one digit |
Nothing on the package says which shape it is. You infer it from the segment lengths, which is why the hyphens matter: strip them and the original segmentation cannot be recovered.