"0281-0365-10" National Drug Code (NDC)

Digifab 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0281-0365-10)
(SAVAGE LABORATORIES, A division of Nycomed US Inc.)

NDC Code0281-0365-10
Package Description1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0281-0365-10)
Product NDC0281-0365
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDigifab
Non-Proprietary NameOvine Digoxin Immune Fab
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20010831
Marketing Category NameBLA
Application NumberBLA103910
ManufacturerSAVAGE LABORATORIES, A division of Nycomed US Inc.
Substance NameOVINE DIGOXIN IMMUNE FAB
Strength38
Strength Unitmg/1
Pharmacy ClassesImmunoglobulin G [EPC],Digoxin Binding Activity [MoA],Immunoglobulins [CS]

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