RECOMBINATE
- Product NDC
- 0944-2845
- 11-digit product format
- 009442845
- Labeler code
- 0944
- Product ID
- 0944-2845_217500ff-5413-48b5-adab-ac72eb2dc128
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- antihemophilic factor recombinant
- Dosage form
- KIT
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- BLA103375
- Marketing category
- BLA
- Marketing start
- 2010-03-15
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RECOMBINATE
- Listing expiration
- 2026-12-31
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0944-2835-01 | RECOMBINATE | 10 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 2000 [iU] in 5mL | 21 |
| 0944-2845-10 | RECOMBINATE | 1 in 1 CARTON | KIT | 1 | | 21 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0944-2845 | RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20250426_d99348b1-edad-41de-aed9-903a6f9f279f.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 |
|---|
| 0944-2835-01 | 00944283501 | 10 mL in 1 VIAL, GLASS | 10 ml | | | | | Historical |
| 0944-2845-10 | 00944284510 | 1 KIT in 1 CARTON (0944-2845-10) * 10 mL in 1 VIAL, GLASS (0944-2835-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) | 1 kit | 2010-03-15 | 0000-00-00 | No | No | Current |