NDC 58394-013

Xyntha

Antihemophilic Factor (recombinant)

Xyntha 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: 58394-013_091cbd40-dc2b-4630-b537-11a3eaca2c44
• NDC: 58394-013
• Product Type: Plasma Derivative
• Proprietary Name: Xyntha
• Generic Name: Antihemophilic Factor (recombinant)
• Dosage Form: Kit
• Marketing Start Date: 2008-08-01
• Marketing Category: BLA / BLA
• Application Number: BLA125264
• Labeler Name: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 58394-013-01

1 KIT in 1 CARTON (58394-013-01) * 4 mL in 1 SYRINGE (58394-018-01) * 1 mL in 1 PACKET * 4 mL in 1 VIAL, SINGLE-USE (58394-113-01)

• Marketing Start Date: 2008-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58394-013-01 [58394001301]

Xyntha KIT

• Marketing Category: BLA
• Application Number: BLA125264
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2008-08-01

Drug Details

NDC Crossover Matching brand name "Xyntha" or generic name "Antihemophilic Factor (recombinant)"

NDC	Brand Name	Generic Name
58394-014	Xyntha	Xyntha
58394-015	Xyntha	Xyntha
58394-022	Xyntha	Xyntha
58394-024	Xyntha	Xyntha
58394-013	Xyntha	Xyntha
58394-012	Xyntha	Xyntha
58394-016	Xyntha	Xyntha
58394-023	Xyntha	Xyntha
58394-025	Xyntha	Xyntha
0026-3782	Kogenate FS	Antihemophilic Factor (Recombinant)
0026-3783	Kogenate FS	Antihemophilic Factor (Recombinant)
0026-3785	Kogenate FS	Antihemophilic Factor (Recombinant)
0026-3786	Kogenate FS	Antihemophilic Factor (Recombinant)
0026-3787	Kogenate FS	Antihemophilic Factor (Recombinant)
0026-3821	Kovaltry	Antihemophilic Factor (Recombinant)
0026-3822	Kovaltry	Antihemophilic Factor (Recombinant)
0026-3824	Kovaltry	Antihemophilic Factor (Recombinant)