"54288-183-01" National Drug Code (NDC)

Zoledronic Acid 1 VIAL, GLASS in 1 CARTON (54288-183-01) / 5 mL in 1 VIAL, GLASS
(BPI Labs LLC)

NDC Code54288-183-01
Package Description1 VIAL, GLASS in 1 CARTON (54288-183-01) / 5 mL in 1 VIAL, GLASS
Product NDC54288-183
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameZoledronic Acid
Non-Proprietary NameZoledronic Acid
Dosage FormINJECTION, SOLUTION, CONCENTRATE
UsageINTRAVENOUS
Start Marketing Date20250605
Marketing Category NameANDA
Application NumberANDA202930
ManufacturerBPI Labs LLC
Substance NameZOLEDRONIC ACID
Strength4
Strength Unitmg/5mL
Pharmacy ClassesBisphosphonate [EPC], Diphosphonates [CS]

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