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RIXUBIS

These highlights do not include all the information needed to use RIXUBIS safely and effectively. See full prescribing information for RIXUBIS. RIXUBIS [Coagulation Factor IX (Recombinant)] For Intravenous Injection, Lyophilized Powder for Solution Initial U.S. Approval: 2013

Approved
Approval ID

f5070a92-96b8-476a-a2dc-18b22d95e5e0

Product Type

PLASMA DERIVATIVE

Effective Date

Apr 7, 2025

Manufacturers
FDA

Takeda Pharmaceuticals America, Inc.

DUNS: 039997266

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

COAGULATION FACTOR IX (RECOMBINANT)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0944-3030
Application NumberBLA125446
Product Classification
M
Marketing Category
C73585
G
Generic Name
COAGULATION FACTOR IX (RECOMBINANT)
Product Specifications
Effective DateApril 7, 2025
FDA Product Classification

COAGULATION FACTOR IX (RECOMBINANT)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0944-3026
Application NumberBLA125446
Product Classification
M
Marketing Category
C73585
G
Generic Name
COAGULATION FACTOR IX (RECOMBINANT)
Product Specifications
Effective DateApril 7, 2025
FDA Product Classification

COAGULATION FACTOR IX (RECOMBINANT)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0944-3028
Application NumberBLA125446
Product Classification
M
Marketing Category
C73585
G
Generic Name
COAGULATION FACTOR IX (RECOMBINANT)
Product Specifications
Effective DateApril 7, 2025
FDA Product Classification

COAGULATION FACTOR IX (RECOMBINANT)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0944-3034
Application NumberBLA125446
Product Classification
M
Marketing Category
C73585
G
Generic Name
COAGULATION FACTOR IX (RECOMBINANT)
Product Specifications
Effective DateApril 7, 2025
FDA Product Classification

COAGULATION FACTOR IX (RECOMBINANT)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0944-3032
Application NumberBLA125446
Product Classification
M
Marketing Category
C73585
G
Generic Name
COAGULATION FACTOR IX (RECOMBINANT)
Product Specifications
Effective DateApril 7, 2025
FDA Product Classification

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RIXUBIS - FDA Drug Approval Details