"61953-0005-1" National Drug Code (NDC)

Flebogamma Dif 1 VIAL in 1 CARTON (61953-0005-1) > 50 mL in 1 VIAL (61953-0005-4)
(GRIFOLS USA, LLC)

NDC Code61953-0005-1
Package Description1 VIAL in 1 CARTON (61953-0005-1) > 50 mL in 1 VIAL (61953-0005-4)
Product NDC61953-0005
Product Type NamePLASMA DERIVATIVE
Proprietary NameFlebogamma Dif
Non-Proprietary NameImmune Globulin Intravenous (human)
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20100727
Marketing Category NameBLA
Application NumberBLA125077
ManufacturerGRIFOLS USA, LLC
Substance NameHUMAN IMMUNOGLOBULIN G
Strength5
Strength Unitg/50mL
Pharmacy ClassesAntigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]

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