"82584-307-03" National Drug Code (NDC)

Azasite 1 BOTTLE, DROPPER in 1 CARTON (82584-307-03) > 2.5 mL in 1 BOTTLE, DROPPER
(Thea Pharma Inc.)

NDC Code82584-307-03
Package Description1 BOTTLE, DROPPER in 1 CARTON (82584-307-03) > 2.5 mL in 1 BOTTLE, DROPPER
Product NDC82584-307
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAzasite
Non-Proprietary NameAzithromycin Monohydrate
Dosage FormSOLUTION/ DROPS
UsageOPHTHALMIC
Start Marketing Date20221101
Marketing Category NameNDA
Application NumberNDA050810
ManufacturerThea Pharma Inc.
Substance NameAZITHROMYCIN MONOHYDRATE
Strength10
Strength Unitmg/mL
Pharmacy ClassesMacrolide Antimicrobial [EPC], Macrolides [CS]

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