NDC 68071-1630

Ofloxacin Otic

Ofloxacin

Ofloxacin Otic is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Ofloxacin.

Product ID68071-1630_84886360-95cc-2e78-e053-2991aa0af8f6
NDC68071-1630
Product TypeHuman Prescription Drug
Proprietary NameOfloxacin Otic
Generic NameOfloxacin
Dosage FormSolution
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2004-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA076527
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameOFLOXACIN
Active Ingredient Strength3 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-1630-3

10 mL in 1 BOTTLE (68071-1630-3)
Marketing Start Date2018-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-1630-3 [68071163003]

Ofloxacin Otic SOLUTION
Marketing CategoryANDA
Application NumberANDA076527
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-28

Drug Details

Active Ingredients

IngredientStrength
OFLOXACIN3 mg/mL

OpenFDA Data

SPL SET ID:76f461da-0e15-aa6d-e053-2a91aa0a9808
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242446
  • UPC Code
  • 0368071163032
  • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]
    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

    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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