ADYNOVATE
- Product NDC
- 0944-4132
- 11-digit product format
- 009444132
- Labeler code
- 0944
- Product ID
- 0944-4132_d8242f09-2cc1-4d6b-ab8b-5fe19ba8dd0a
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- antihemophilic factor (recombinant) pegylated
- Dosage form
- KIT
- Labeler
- BAXALTA US INC.
- Application
- BLA125566
- Marketing category
- BLA
- Marketing start
- 2016-07-28
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 0944-4132 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0944-4132 | 0944-4132-02 | D | Discontinued by firm | | 2026-07-31 |
FDA-Initiated Inactive NDC Indexing#
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125566 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | Rx | 2026-06-01 |