ADZYNMA
- Product NDC
- 64764-140
- 11-digit product format
- 647640140
- Labeler code
- 64764
- Product ID
- 64764-140_675b72f9-d3f0-4afc-9023-7024ddfbfc30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Apadamtase Alfa
- Dosage form
- KIT
- Labeler
- TAKEDA PHARMACEUTICALS AMERICA, INC.
- Application
- BLA125795
- Marketing category
- BLA
- Marketing start
- 2023-11-09
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ADZYNMA
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 2670293, 2670300, 2670311, 2670313 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64764-130-01 | ADZYNMA | 500 [iU] in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 500 [iU] | 500 [iU] in 1[iU] | 6 |
| 64764-140-05 | ADZYNMA | 1 in 1 CARTON | KIT | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64764-140 | ADZYNMA (APADAMTASE ALFA) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 6 | Current NDC, 2 package rows | 20240831_22728e96-efa0-46c1-bdd1-ad89a796d5e3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64764-130-01 | 64764013001 | 500 [iU] in 1 VIAL, SINGLE-DOSE | | | | | Historical |
| 64764-140-05 | 64764014005 | 1 KIT in 1 CARTON (64764-140-05) * 500 [iU] in 1 VIAL, SINGLE-DOSE (64764-130-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) | 1 kit | 2023-11-09 | No | No | Current |