NDC 61919-175

OFLOXACIN

Ofloxacin

OFLOXACIN is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Ofloxacin.

Product ID61919-175_bc784e9d-afc1-4107-a1e6-b733d00813a0
NDC61919-175
Product TypeHuman Prescription Drug
Proprietary NameOFLOXACIN
Generic NameOfloxacin
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA076407
Labeler NameDIRECT RX
Substance NameOFLOXACIN
Active Ingredient Strength3 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-175-05

5 mL in 1 BOTTLE, DROPPER (61919-175-05)
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-175-05 [61919017505]

OFLOXACIN SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA076407
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-01-01
Inactivation Date2020-01-31

NDC 61919-175-15 [61919017515]

OFLOXACIN SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA076407
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OFLOXACIN3 mg/mL

OpenFDA Data

SPL SET ID:bed09b0a-774b-414e-b253-a0ff5f0685a0
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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