"68083-199-10" National Drug Code (NDC)

Azithromycin Monohydrate 10 VIAL in 1 CARTON (68083-199-10) / 10 mL in 1 VIAL
(Gland Pharma Limited)

NDC Code68083-199-10
Package Description10 VIAL in 1 CARTON (68083-199-10) / 10 mL in 1 VIAL
Product NDC68083-199
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAzithromycin Monohydrate
Non-Proprietary NameAzithromycin Monohydrate
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20091109
Marketing Category NameANDA
Application NumberANDA065501
ManufacturerGland Pharma Limited
Substance NameAZITHROMYCIN MONOHYDRATE
Strength500
Strength Unitmg/10mL
Pharmacy ClassesMacrolide Antimicrobial [EPC], Macrolides [CS]

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