OBIZUR
- Product NDC
- 0944-5001
- Requested package NDC
- 0944-5001-01
- 11-digit product format
- 009445001
- Labeler code
- 0944
- Product ID
- 0944-5001_181004b3-db8d-4be1-a47d-604fd0cff078
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Antihemophilic Factor (Recombinant), Porcine Sequence
- Dosage form
- KIT
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- BLA125512
- Marketing category
- BLA
- Marketing start
- 2014-10-23
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OBIZUR
- 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 |
|---|
| 0944-5001-01 | OBIZUR | 1 in 1 CARTON | KIT | 1 | | 18 |
| 0944-5011-01 | OBIZUR | 1 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 mL | 500 [USP'U] in 1mL | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT | ACTIVE INGREDIENT | 6892UQT2GK | OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 1 | |
| ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT | ACTIVE MOIETY | 6892UQT2GK | OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 1 | |
| CALCIUM CHLORIDE | INACTIVE INGREDIENT | M4I0D6VV5M | OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 1 | |
| TROMETHAMINE | INACTIVE INGREDIENT | 023C2WHX2V | OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 1 | |
| TROMETHAMINE HYDROCHLORIDE | INACTIVE INGREDIENT | 383V75M34E | OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0944-5001 | OBIZUR (ANTIHEMOPHILIC FACTOR (RECOMBINANT), PORCINE SEQUENCE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 18 | Current NDC, Legacy NDC, 2 package rows | 20250309_a69ccbb3-7648-4978-8c6d-7ca6b95a9b01.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125512 | Obizur | Antihemophilic Factor (Recombinant), Porcine Sequence | 351(a) | Rx | 2026-09-01 |
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 |
|---|
| 0944-5001-01 | 00944500101 | 1 KIT in 1 CARTON (0944-5001-01) * 1 mL in 1 VIAL, GLASS (0944-5011-01) * 1 mL in 1 SYRINGE, GLASS (0944-0011-01) | 1 kit | 2014-10-23 | 0000-00-00 | No | No | Current |