"53270-0054-1" National Drug Code (NDC)

Hepagam B 1 VIAL, SINGLE-DOSE in 1 CARTON (53270-0054-1) > 5 mL in 1 VIAL, SINGLE-DOSE
(Cangene BioPharma, LLC)

NDC Code53270-0054-1
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (53270-0054-1) > 5 mL in 1 VIAL, SINGLE-DOSE
Product NDC53270-0054
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHepagam B
Non-Proprietary NameHepatitis B Immune Globulin (human)
Dosage FormINJECTION, SOLUTION
UsageINTRAMUSCULAR; INTRAVENOUS
Start Marketing Date20100801
Marketing Category NameBLA
Application NumberBLA125035
ManufacturerCangene BioPharma, LLC
Substance NameHUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Strength50
Strength Unitmg/mL
Pharmacy ClassesHuman Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient]

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