Home NDC 0944-3026 RIXUBIS
Product NDC 0944-3026
11-digit product format 009443026
Labeler code 0944
Product ID 0944-3026_1426f595-e663-4c4a-8318-fed3310867f8
Type PLASMA DERIVATIVE
Nonproprietary name COAGULATION FACTOR IX (RECOMBINANT)
Dosage form KIT
Labeler Takeda Pharmaceuticals America, Inc.
Application BLA125446
Marketing category BLA
Marketing start 2013-10-04
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base RIXUBIS
Listing expiration 2027-12-31 DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0944-3025-01 RIXUBIS 5 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 5 mL 250 [iU] in 5mL 14 0944-3026-02 RIXUBIS 1 in 1 CARTON KIT 1 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0944-3026 RIXUBIS (COAGULATION FACTOR IX (RECOMBINANT)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20250410_f5070a92-96b8-476a-a2dc-18b22d95e5e0.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 0944-3025-01 00944302501 5 mL in 1 VIAL, GLASS 5 ml Historical 0944-3026-02 00944302602 1 KIT in 1 CARTON (0944-3026-02) * 5 mL in 1 VIAL, GLASS (0944-3025-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) 1 kit 2013-10-04 0000-00-00 No No Current