"13533-800-12" National Drug Code (NDC)

Gamunex-c 1 VIAL, GLASS in 1 CARTON (13533-800-12) > 10 mL in 1 VIAL, GLASS (13533-800-13)
(GRIFOLS USA, LLC)

NDC Code13533-800-12
Package Description1 VIAL, GLASS in 1 CARTON (13533-800-12) > 10 mL in 1 VIAL, GLASS (13533-800-13)
Product NDC13533-800
Product Type NamePLASMA DERIVATIVE
Proprietary NameGamunex-c
Non-Proprietary NameImmune Globulin (human)
Dosage FormINJECTION
UsageINTRAVENOUS; SUBCUTANEOUS
Start Marketing Date20101013
Marketing Category NameBLA
Application NumberBLA125046
ManufacturerGRIFOLS USA, LLC
Substance NameHUMAN IMMUNOGLOBULIN G
Strength10
Strength Unitg/100mL
Pharmacy ClassesAntigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]

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