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
- Labeler
- TAKEDA PHARMACEUTICALS AMERICA, INC.NDC labeler code 64764
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125795
- Marketing start
- Listing expires
- Identifiers
- Product ID 64764-145_8053bf08-daa3-485c-916e-05c046f82c9fSPL ID 8053bf08-daa3-485c-916e-05c046f82c9f
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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 64764-145
- What is NDC 64764-145?
- 64764-145 is the product NDC for Adzynma (apadamtase alfa) kit, listed with the FDA by TAKEDA PHARMACEUTICALS AMERICA, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Adzynma (Apadamtase Alfa).
- Who is the labeler?
- TAKEDA PHARMACEUTICALS AMERICA, INC., NDC labeler code 64764. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Adzynma?
- 1 other product NDC are listed under this name. See all Adzynma NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Adzynma products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Adzynmaapadamtase alfa | — | Kit | TAKEDA PHARMACEUTICALS AMERICA, INC. | 64764-140 | 64764-0140-05 |
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 |