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"68516-5219-1" National Drug Code (NDC)

Albutein 1 BAG in 1 CARTON (68516-5219-1) / 500 mL in 1 BAG (68516-5219-0)
(GRIFOLS USA, LLC)

NDC Code68516-5219-1
Package Description1 BAG in 1 CARTON (68516-5219-1) / 500 mL in 1 BAG (68516-5219-0)
Product NDC68516-5219
Product Type NamePLASMA DERIVATIVE
Proprietary NameAlbutein
Non-Proprietary NameAlbumin (human)
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20231109
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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