"53002-2604-1" National Drug Code (NDC)

Ofloxacin Otic 5 mL in 1 BOTTLE, DROPPER (53002-2604-1)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-2604-1
Package Description5 mL in 1 BOTTLE, DROPPER (53002-2604-1)
Product NDC53002-2604
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOfloxacin Otic
Non-Proprietary NameOfloxacin
Dosage FormSOLUTION
UsageAURICULAR (OTIC)
Start Marketing Date20040514
Marketing Category NameANDA
Application NumberANDA076527
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameOFLOXACIN
Strength3
Strength Unitmg/mL
Pharmacy ClassesQuinolone Antimicrobial [EPC], Quinolones [CS]

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