Prescription drug · BLA
Adzynma (apadamtase alfa) NDC 64764-145
Kit · TAKEDA PHARMACEUTICALS AMERICA, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64764-145-05 | 64764014505 | 1 KIT in 1 CARTON (64764-145-05) * 1500 [iU] in 1 VIAL, SINGLE-DOSE (64764-135-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)Marketed from Nov 9, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Adzynma
- Generic name (nonproprietary)
- apadamtase alfa
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125795
- Marketing start
- Listing expires
- Identifiers
- Product ID 64764-145_758b0d1f-9d6c-42f9-a23b-6f75e9181842SPL ID 758b0d1f-9d6c-42f9-a23b-6f75e9181842SPL set ID 22728e96-efa0-46c1-bdd1-ad89a796d5e3RxCUI 2670293, 2670300, 2670311, 2670313
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N464764014505followed by a unit qualifier and the quantityPackage 64764-0145-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ADZYNMA is indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP) [see Use in Specific Populations (8.4) , Clinical Studies (14) ]. ADZYNMA (ADAMTS13, recombinant-krhn) is a human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” (rADAMTS13) indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 125795
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Adzynmaapadamtase alfa | — | Kit | TAKEDA PHARMACEUTICALS AMERICA, INC. | 64764-140 |