"53002-3221-5" National Drug Code (NDC)

Azithromycin Monohydrate 5 TABLET in 1 BOTTLE (53002-3221-5)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-3221-5
Package Description5 TABLET in 1 BOTTLE (53002-3221-5)
Product NDC53002-3221
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAzithromycin Monohydrate
Non-Proprietary NameAzithromycin Monohydrate
Dosage FormTABLET
UsageORAL
Start Marketing Date20150818
Marketing Category NameANDA
Application NumberANDA065399
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameAZITHROMYCIN DIHYDRATE
Strength500
Strength Unitmg/1
Pharmacy ClassesMacrolide Antimicrobial [EPC], Macrolides [CS]

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