"53270-0051-1" National Drug Code (NDC)

Hepagam B 1 VIAL, SINGLE-DOSE in 1 CARTON (53270-0051-1) > 5 mL in 1 VIAL, SINGLE-DOSE
(Cangene bioPharma Inc.)

NDC Code53270-0051-1
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (53270-0051-1) > 5 mL in 1 VIAL, SINGLE-DOSE
Product NDC53270-0051
Product Type NamePLASMA DERIVATIVE
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 Inc.
Substance NameHUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Strength312
Strength Unit[iU]/mL
Pharmacy ClassesHuman Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],Immunoglobulins [CS]

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