"0378-5431-35" National Drug Code (NDC)

Gatifloxacin 1 BOTTLE in 1 CARTON (0378-5431-35) > 2.5 mL in 1 BOTTLE
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5431-35
Package Description1 BOTTLE in 1 CARTON (0378-5431-35) > 2.5 mL in 1 BOTTLE
Product NDC0378-5431
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGatifloxacin
Non-Proprietary NameGatifloxacin
Dosage FormSOLUTION/ DROPS
UsageOPHTHALMIC
Start Marketing Date20190308
Marketing Category NameANDA
Application NumberANDA206446
ManufacturerMylan Pharmaceuticals Inc.
Substance NameGATIFLOXACIN
Strength5
Strength Unitmg/mL
Pharmacy ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]

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