NDC 63629-8716

Ofloxacin Otic

Ofloxacin

Ofloxacin Otic is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Ofloxacin.

Product ID63629-8716_4757f3cc-b3e6-41ea-a73c-a6026227c4a3
NDC63629-8716
Product TypeHuman Prescription Drug
Proprietary NameOfloxacin Otic
Generic NameOfloxacin
Dosage FormSolution
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2004-05-14
Marketing CategoryANDA /
Application NumberANDA076527
Labeler NameBryant Ranch Prepack
Substance NameOFLOXACIN
Active Ingredient Strength3 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63629-8716-1

5 mL in 1 BOTTLE, DROPPER (63629-8716-1)
Marketing Start Date2021-08-19
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Ofloxacin Otic" or generic name "Ofloxacin"

NDCBrand NameGeneric Name
50090-1090Ofloxacin OticOfloxacin
68071-1588Ofloxacin OticOfloxacin Otic
68071-1630Ofloxacin OticOfloxacin Otic
68788-9504Ofloxacin OticOfloxacin Otic
53002-2604Ofloxacin OticOfloxacin Otic
60505-0363Ofloxacin OticOfloxacin Otic
63187-184Ofloxacin OticOfloxacin Otic
72189-108OFLOXACIN OTICOFLOXACIN OTIC
11980-779OCUFLOXofloxacin
0404-7189OfloxacinOfloxacin
0517-0760OfloxacinOfloxacin
13985-602OfloxacinOfloxacin
17478-713OfloxacinOfloxacin
21695-439OfloxacinOfloxacin
24208-410OfloxacinOfloxacin
24208-434OfloxacinOfloxacin
33261-737OfloxacinOfloxacin
40042-049OfloxacinOfloxacin
42254-257OfloxacinOfloxacin
50090-0891OfloxacinOfloxacin
50090-1346OfloxacinOfloxacin
50090-1736OfloxacinOfloxacin
50090-5186Ofloxacinofloxacin
50090-5209Ofloxacinofloxacin
50090-5210Ofloxacinofloxacin
50090-5425OfloxacinOfloxacin
50090-5670OfloxacinOfloxacin Otic
50383-024OfloxacinOfloxacin
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