NDC 50633-110

CroFab

Ovine Crotalidae Venoms Immune Fab

CroFab is a Intravenous Injection, Powder, Lyophilized, For Solution in the Plasma Derivative category. It is labeled and distributed by Btg International Inc.. The primary component is Agkistrodon Piscivorus Immune Fab Antivenin (ovine); Crotalus Adamanteus Immune Fab Antivenin (ovine); Crotalus Atrox Immune Fab Antivenin (ovine); Crotalus Scutulatus Immune Fab Antivenin (ovine).

• Product ID: 50633-110_19e72abf-5863-4e4a-8023-754dc2016427
• NDC: 50633-110
• Product Type: Plasma Derivative
• Proprietary Name: CroFab
• Generic Name: Ovine Crotalidae Venoms Immune Fab
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2000-02-10
• Marketing Category: BLA / BLA
• Application Number: BLA103788
• Labeler Name: BTG International Inc.
• Substance Name: AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE); CROTALUS ADAMANTEUS IMMUNE FAB ANTIVENIN (OVINE); CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE); CROTALUS SCUTULATUS IMMUNE FAB ANTIVENIN (OVINE)
• Active Ingredient Strength: 1 g/1; g/1; g/1; g/1
• Pharm Classes: Antivenin [EPC], Antivenin [EPC], Antivenin [EPC], Antivenin [EPC], Antivenins [Chemical/Ingredient], Antivenins [Chemical/Ingredient], Antivenins [Chemical/Ingredient], Antivenins [Chemical/Ingredient], Passively Acquired Immunity [PE], Passively Acquired Immunity [PE], Passively Acquired Immunity [PE], Passively Acquired Immunity [PE], Venom Neutralization [MoA], Venom Neutralization [MoA], Venom Neutralization [MoA], Venom Neutralization [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50633-110-12

2 VIAL, GLASS in 1 CARTON (50633-110-12) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (50633-110-11)

• Marketing Start Date: 2000-02-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50633-110-11 [50633011011]

CroFab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103788
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2018-10-23

NDC 50633-110-12 [50633011012]

CroFab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103788
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2000-02-10

Drug Details

Active Ingredients

Ingredient	Strength
CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE)	1 g/1

Pharmacological Class

• Antivenin [EPC]
• Passively Acquired Immunity [PE]
• Venom Neutralization [MoA]
• Antivenins [Chemical/Ingredient]
• Antivenin [EPC]
• Passively Acquired Immunity [PE]
• Venom Neutralization [MoA]
• Antivenins [Chemical/Ingredient]
• Passively Acquired Immunity [PE]
• Venom Neutralization [MoA]
• Antivenins [Chemical/Ingredient]
• Antivenin [EPC]
• Antivenin [EPC]
• Passively Acquired Immunity [PE]
• Venom Neutralization [MoA]
• Antivenins [Chemical/Ingredient]