The marketing category states the legal basis on which a drug is sold: NDA for a brand-name drug approved on its own evidence, ANDA for a generic proved bioequivalent to that brand, and BLA for a licensed biological product.
The categories you will actually see
| Category | What it means | Typical products |
|---|---|---|
| NDA | Brand-name drug approved on its own clinical evidence | Most innovator small molecules |
| ANDA | Generic proved bioequivalent to a reference brand | Multi-source generics |
| BLA | Licensed biological product | Monoclonal antibodies, vaccines, cell and gene therapies |
| NDA authorized generic | The brand product sold under a generic label | Authorised generics |
| OTC monograph | Conforms to a published OTC rulebook; no individual approval | Store-brand analgesics, antacids |
| Unapproved drug other | Legally marketed without approval, largely historical | Some long-marketed preparations |
Why the category matters for billing
A BLA product with no permanent HCPCS code belongs on J3590, the unclassified biologics code, while a small molecule in the same position belongs on J3490. Some payers reject the wrong one outright.
The category also predicts how many NDCs a molecule will have. One NDA usually means a handful; an ANDA molecule with a dozen manufacturers can produce hundreds of distinct codes for the same tablet.
505(b)(2), the category people miss
A 505(b)(2) product is approved under an NDA number but relied partly on data the applicant did not generate — typically a reformulation, a new route or a new strength of an existing drug. It looks like a brand in the data and behaves like one commercially, but its evidence base is narrower.
Questions
Is a biosimilar an ANDA?
No. Biologics cannot be copied exactly, so biosimilars go through a separate abbreviated licensure pathway and appear under BLA, not ANDA.
Does OTC monograph mean unapproved?
It means individually unapproved but lawfully marketed under a published rulebook. It is not the same as the unapproved drug other category.