"13533-636-05" National Drug Code (NDC)

Hyperhep B 1 VIAL, GLASS in 1 CARTON (13533-636-05) / 5 mL in 1 VIAL, GLASS (13533-636-50)
(GRIFOLS USA, LLC)

NDC Code13533-636-05
Package Description1 VIAL, GLASS in 1 CARTON (13533-636-05) / 5 mL in 1 VIAL, GLASS (13533-636-50)
Product NDC13533-636
Product Type NamePLASMA DERIVATIVE
Proprietary NameHyperhep B
Non-Proprietary NameHepatitis B Immune Globulin (human)
Dosage FormINJECTION
UsageINTRAMUSCULAR
Start Marketing Date19961009
Marketing Category NameBLA
Application NumberBLA101146
ManufacturerGRIFOLS USA, LLC
Substance NameHUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Strength220
Strength Unit[iU]/mL
Pharmacy ClassesHuman Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]

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