NDC 58394-633

BeneFIX

Coagulation Factor Ix (recombinant)

BeneFIX is a Kit in the Plasma Derivative category. It is labeled and distributed by Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc. The primary component is .

• Product ID: 58394-633_21a8f583-c575-428c-9a0a-dfc39445dfcc
• NDC: 58394-633
• Product Type: Plasma Derivative
• Proprietary Name: BeneFIX
• Generic Name: Coagulation Factor Ix (recombinant)
• Dosage Form: Kit
• Marketing Start Date: 1997-02-01
• Marketing Category: BLA / BLA
• Application Number: BLA103677
• Labeler Name: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 58394-633-03

1 KIT in 1 CARTON (58394-633-03) * 5 mL in 1 VIAL, SINGLE-USE (58394-133-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET

• Marketing Start Date: 1997-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58394-633-03 [58394063303]

Benefix KIT

• Marketing Category: BLA
• Application Number: BLA103677
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 1997-02-01

Drug Details

NDC Crossover Matching brand name "BeneFIX" or generic name "Coagulation Factor Ix (recombinant)"

NDC	Brand Name	Generic Name
58394-633	BeneFIX	coagulation factor ix (recombinant)
58394-634	BeneFIX	coagulation factor ix (recombinant)
58394-635	BeneFIX	coagulation factor ix (recombinant)
58394-637	BeneFIX	BeneFIX
58394-636	BeneFIX	BeneFIX
0944-3026	RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)
0944-3028	RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)
0944-3030	RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)
0944-3032	RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)
0944-3034	RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)