"65162-758-83" National Drug Code (NDC)

Azithromycin Monohydrate 1 BOTTLE in 1 CARTON (65162-758-83) / 15 mL in 1 BOTTLE
(Amneal Pharmaceuticals LLC)

NDC Code65162-758-83
Package Description1 BOTTLE in 1 CARTON (65162-758-83) / 15 mL in 1 BOTTLE
Product NDC65162-758
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAzithromycin Monohydrate
Non-Proprietary NameAzithromycin Monohydrate
Dosage FormPOWDER, FOR SUSPENSION
UsageORAL
Start Marketing Date20180723
Marketing Category NameANDA
Application NumberANDA205666
ManufacturerAmneal Pharmaceuticals LLC
Substance NameAZITHROMYCIN MONOHYDRATE
Strength200
Strength Unitmg/5mL
Pharmacy ClassesMacrolide Antimicrobial [EPC], Macrolides [CS]

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