"68516-5214-5" National Drug Code (NDC)

Albutein 1 VIAL in 1 CARTON (68516-5214-5) / 50 mL in 1 VIAL (68516-5214-6)
(GRIFOLS USA, LLC)

NDC Code68516-5214-5
Package Description1 VIAL in 1 CARTON (68516-5214-5) / 50 mL in 1 VIAL (68516-5214-6)
Product NDC68516-5214
Product Type NamePLASMA DERIVATIVE
Proprietary NameAlbutein
Non-Proprietary NameAlbumin (human)
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20220301
Marketing Category NameBLA
Application NumberBLA102478
ManufacturerGRIFOLS USA, LLC
Substance NameALBUMIN HUMAN
Strength12.5
Strength Unitg/250mL
Pharmacy ClassesHuman Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]

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