NDC 50383-024

Ofloxacin

Ofloxacin

Ofloxacin is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Ofloxacin.

Product ID50383-024_0095d1d6-d83e-4e22-aa61-3b4753f0753b
NDC50383-024
Product TypeHuman Prescription Drug
Proprietary NameOfloxacin
Generic NameOfloxacin
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2004-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA076615
Labeler NameHi-Tech Pharmacal Co., Inc.
Substance NameOFLOXACIN
Active Ingredient Strength3 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50383-024-05

1 BOTTLE, DROPPER in 1 CARTON (50383-024-05) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2004-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-024-05 [50383002405]

Ofloxacin SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA076615
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-05-14

NDC 50383-024-10 [50383002410]

Ofloxacin SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA076615
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-05-14

Drug Details

Active Ingredients

IngredientStrength
OFLOXACIN3 mg/mL

OpenFDA Data

SPL SET ID:7882f70e-d228-4c52-9390-0d927c51af1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312075
  • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

    Medicade Reported Pricing

    50383024971 BROMFENAC SODIUM 0.09% EYE DRP

    Pricing Unit: ML | Drug Type:

    50383024116 LEVETIRACETAM 100 MG/ML SOLN

    Pricing Unit: ML | Drug Type:

    50383002410 OFLOXACIN 0.3% EYE DROPS

    Pricing Unit: ML | Drug Type:

    50383002405 OFLOXACIN 0.3% EYE DROPS

    Pricing Unit: ML | Drug Type:

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.