"63323-562-15" National Drug Code (NDC)

Bivalirudin 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41)
(Fresenius Kabi USA, LLC)

NDC Code63323-562-15
Package Description10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41)
Product NDC63323-562
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBivalirudin
Non-Proprietary NameBivalirudin
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20171030
Marketing Category NameANDA
Application NumberANDA090189
ManufacturerFresenius Kabi USA, LLC
Substance NameBIVALIRUDIN
Strength250
Strength Unitmg/1
Pharmacy ClassesAnti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]

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