"50633-110-12" National Drug Code (NDC)

NDC Code	50633-110-12
Package Description	2 VIAL, GLASS in 1 CARTON (50633-110-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (50633-110-11)
Product NDC	50633-110
Product Type Name	PLASMA DERIVATIVE
Proprietary Name	Crofab
Non-Proprietary Name	Ovine Crotalidae Venoms Immune Fab
Dosage Form	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Usage	INTRAVENOUS
Start Marketing Date	20000210
Marketing Category Name	BLA
Application Number	BLA103788
Manufacturer	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)
Strength	1; 1; 1; 1
Strength Unit	g/1; g/1; g/1; g/1
Pharmacy 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]