"13533-335-04" National Drug Code (NDC)

Gamastan 1 VIAL in 1 CARTON (13533-335-04) / 2 mL in 1 VIAL (13533-335-40)
(GRIFOLS USA, LLC)

NDC Code13533-335-04
Package Description1 VIAL in 1 CARTON (13533-335-04) / 2 mL in 1 VIAL (13533-335-40)
Product NDC13533-335
Product Type NamePLASMA DERIVATIVE
Proprietary NameGamastan
Non-Proprietary NameImmune Globulin (human)
Dosage FormINJECTION, SOLUTION
UsageINTRAMUSCULAR
Start Marketing Date20180205
Marketing Category NameBLA
Application NumberBLA101134
ManufacturerGRIFOLS USA, LLC
Substance NameHUMAN IMMUNOGLOBULIN G
Strength.165
Strength Unitg/mL
Pharmacy ClassesAntigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]

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