Home NDC 0944-5001 OBIZUR
Product NDC 0944-5001
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 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
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 0944-5001-05 00944500105 5 CARTON in 1 CARTON (0944-5001-05) > 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) 5 carton 2014-10-23 0000-00-00 No No Current 0944-5001-10 00944500110 10 CARTON in 1 CARTON (0944-5001-10) > 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) 10 carton 2014-10-23 0000-00-00 No No Current 0944-5011-01 00944501101 1 mL in 1 VIAL, GLASS 1 ml Historical