"83634-400-10" National Drug Code (NDC)

Bivalirudin 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-400-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-400-41)
(Avenacy, Inc.)

NDC Code83634-400-10
Package Description10 VIAL, SINGLE-DOSE in 1 CARTON (83634-400-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-400-41)
Product NDC83634-400
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBivalirudin
Non-Proprietary NameBivalirudin
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20231218
Marketing Category NameANDA
Application NumberANDA210031
ManufacturerAvenacy, Inc.
Substance NameBIVALIRUDIN
Strength250
Strength Unitmg/1
Pharmacy ClassesAnti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]

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