NDC 55545-1003

Ofloxacin

Ofloxacin

Ofloxacin is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Fdc Limited. The primary component is Ofloxacin.

Product ID55545-1003_d2b7e684-27f1-4ee7-b235-58b632ac9694
NDC55545-1003
Product TypeHuman Prescription Drug
Proprietary NameOfloxacin
Generic NameOfloxacin
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-12-15
Marketing CategoryANDA / ANDA
Application NumberANDA078559
Labeler NameFDC Limited
Substance NameOFLOXACIN
Active Ingredient Strength3 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55545-1003-1

1 BOTTLE, PLASTIC in 1 CARTON (55545-1003-1) > 5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2014-12-15
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
OFLOXACIN3 mg/mL

OpenFDA Data

SPL SET ID:b4d09b4d-bc6a-405b-91c8-e4246336a1f7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312075
  • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

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

    NDCBrand NameGeneric Name
    0404-7189OfloxacinOfloxacin
    0517-0760OfloxacinOfloxacin
    13985-602OfloxacinOfloxacin
    17478-713OfloxacinOfloxacin
    21695-439OfloxacinOfloxacin
    21695-881OfloxacinOfloxaxin
    24208-410OfloxacinOfloxacin
    24208-434OfloxacinOfloxacin
    33261-737OfloxacinOfloxacin
    40042-049OfloxacinOfloxacin
    42254-257OfloxacinOfloxacin
    50090-0891OfloxacinOfloxacin
    50090-1346OfloxacinOfloxacin
    50090-1736OfloxacinOfloxacin
    50090-3836OfloxacinOfloxaxin
    50090-5186Ofloxacinofloxacin
    50090-5209Ofloxacinofloxacin
    50090-5210Ofloxacinofloxacin
    50090-5425OfloxacinOfloxacin
    68047-713ofloxacinofloxacin
    68071-1607OfloxacinOfloxacin
    68071-4055OfloxacinOfloxacin
    68387-106OfloxacinOfloxacin
    68788-0617OfloxacinOfloxacin
    68788-8993OfloxacinOfloxacin
    68788-7003OfloxacinOfloxacin
    68788-9204OfloxacinOfloxacin
    70518-0308OfloxacinOfloxacin
    70518-0192OfloxacinOfloxacin
    70518-1892OfloxacinOfloxacin
    71209-099OFLOXACINOFLOXACIN
    71209-098OFLOXACINOFLOXACIN
    71209-097OFLOXACINOFLOXACIN
    75834-119OFLOXACINOFLOXACIN
    75834-112OFLOXACINOFLOXACIN
    75834-200OFLOXACINOFLOXACIN
    75834-201OFLOXACINOFLOXACIN
    75834-120OFLOXACINOFLOXACIN
    75834-199OFLOXACINOFLOXACIN
    50383-024OfloxacinOfloxacin
    50436-0713OfloxacinOfloxacin
    50383-025OfloxacinOfloxacin
    50436-6112OfloxacinOfloxacin
    52959-763ofloxacinofloxacin
    53002-1324OfloxacinOfloxacin
    53002-1604OfloxacinOfloxacin
    55111-162OfloxacinOfloxacin
    55111-161OfloxacinOfloxacin
    55111-160OfloxacinOfloxacin
    55700-066OfloxacinOfloxacin

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