RECOMBINATE
- Product NDC
- 0944-2842
- 11-digit product format
- 009442842
- Labeler code
- 0944
- Product ID
- 0944-2842_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
- 2009-04-10
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0944-2832-01 | RECOMBINATE | 10 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 500 [iU] in 5mL | 21 |
| 0944-2842-10 | RECOMBINATE | 1 in 1 CARTON | KIT | 1 | | 21 |
| 0944-2842-15 | Recombinate | 1 in 1 CARTON | KIT | 1 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0944-2842 | RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20250426_d99348b1-edad-41de-aed9-903a6f9f279f.zip |
| 0944-2842 | RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 7 | Current NDC, Legacy NDC, 1 package rows | 20120103_d74e59ba-bfeb-4c48-9596-da44328561a9.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1719222 | antihemophilic factor, human recombinant 1 UNT Injection | PSN | d99348b1-edad-41de-aed9-903a6f9f279f | 21 |
| 1719243 | RECOMBINATE 1 UNT Injection | PSN | d99348b1-edad-41de-aed9-903a6f9f279f | 21 |
| 1719243 | antihemophilic factor, human recombinant 1 UNT Injection [Recombinate] | SBD | d99348b1-edad-41de-aed9-903a6f9f279f | 21 |
| 1719222 | antihemophilic factor, human recombinant 1 UNT Injection | SCD | d99348b1-edad-41de-aed9-903a6f9f279f | 21 |
| 1719222 | factor VIII, human recombinant 1 UNT Injection | SY | d99348b1-edad-41de-aed9-903a6f9f279f | 21 |
| 1719243 | Recombinate 1 UNT Injection | SY | d99348b1-edad-41de-aed9-903a6f9f279f | 21 |
| 1719222 | antihemophilic factor, human recombinant 1 UNT Injection | PSN | d74e59ba-bfeb-4c48-9596-da44328561a9 | 7 |
| 1719243 | RECOMBINATE 1 UNT Injection | PSN | d74e59ba-bfeb-4c48-9596-da44328561a9 | 7 |
| 1719243 | antihemophilic factor, human recombinant 1 UNT Injection [Recombinate] | SBD | d74e59ba-bfeb-4c48-9596-da44328561a9 | 7 |
| 1719222 | antihemophilic factor, human recombinant 1 UNT Injection | SCD | d74e59ba-bfeb-4c48-9596-da44328561a9 | 7 |
| 1719222 | factor VIII, human recombinant 1 UNT Injection | SY | d74e59ba-bfeb-4c48-9596-da44328561a9 | 7 |
| 1719243 | Recombinate 1 UNT Injection | SY | d74e59ba-bfeb-4c48-9596-da44328561a9 | 7 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0944-2832-01 | 00944283201 | 10 mL in 1 VIAL, GLASS | 10 ml | | | | | Historical |
| 0944-2842-10 | 00944284210 | 1 KIT in 1 CARTON (0944-2842-10) * 10 mL in 1 VIAL, GLASS (0944-2832-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) | 1 kit | 2009-04-10 | 0000-00-00 | No | No | Current |
| 0944-2842-15 | 00944284215 | 1 in 1 CARTON | | | | | | Historical |