ADYNOVATE
- Product NDC
- 0944-4622
- 11-digit product format
- 009444622
- Labeler code
- 0944
- Product ID
- 0944-4622_23fe329d-5d0a-4ebd-8dae-34a74a23b1d4
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Antihemophilic Factor (Recombinant) PEGylated
- Dosage form
- KIT
- Labeler
- Takeda Pharmaceuticals Amercia, Inc.
- Application
- BLA125566
- Marketing category
- BLA
- Marketing start
- 2016-07-28
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ADYNOVATE
- Listing expiration
- 2026-12-31
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0944-4622-01 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d0-f09d-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ADYNOVATE ® safely and effectively. See full prescribing information for ADYNOVATE. ADYNOVATE, (Antihemophilic Factor, Recombinant, PEGylated) Lyophilized Powder for Solution For Intravenous Injection Initial U.S. Approval: 2015 |
| 0944-4622-01 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d0-f09d-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ADYNOVATE ® safely and effectively. See full prescribing information for ADYNOVATE. ADYNOVATE, (Antihemophilic Factor, Recombinant, PEGylated) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 2015 |
| 0944-4622-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f09d-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ADYNOVATE ® safely and effectively. See full prescribing information for ADYNOVATE. ADYNOVATE, (Antihemophilic Factor, Recombinant, PEGylated) Lyophilized Powder for Solution For Intravenous Injection Initial U.S. Approval: 2015 |
| 0944-4622-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f09d-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ADYNOVATE ® safely and effectively. See full prescribing information for ADYNOVATE. ADYNOVATE, (Antihemophilic Factor, Recombinant, PEGylated) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 2015 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0944-4137-01 | ADYNOVATE | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 250 [iU] in 2mL | 23 |
| 0944-4622-01 | ADYNOVATE | 1 in 1 CARTON | KIT | 1 | | 23 |
| 0944-4622-02 | ADYNOVATE | 1 in 1 KIT | KIT | 1 | | 23 |
| 0944-4622-03 | ADYNOVATE | 1 in 1 CONTAINER | KIT | 1 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0944-4622 | ADYNOVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED) KIT [TAKEDA PHARMACEUTICALS AMERCIA, INC.] | 22 | Current NDC, Legacy NDC, 4 package rows | 20250331_ef290433-997f-4e98-86d6-42f6a99d6d18.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0944-4137-01 | 00944413701 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | | Historical |
| 0944-4622-01 | 00944462201 | 1 KIT in 1 CARTON (0944-4622-01) / 1 CONTAINER in 1 KIT (0944-4622-02) / 1 KIT in 1 CONTAINER (0944-4622-03) * 5 mL in 1 VIAL, GLASS (0944-4137-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) | 1 kit | 2016-07-28 | 0000-00-00 | No | No | Current |
| 0944-4622-02 | 00944462202 | 1 in 1 KIT | | | | | | Historical |
| 0944-4622-03 | 00944462203 | 1 in 1 CONTAINER | | | | | | Historical |