NDC 75834-199

OFLOXACIN

Ofloxacin

OFLOXACIN is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Nivagen Pharmaceuticals, Inc.. The primary component is Ofloxacin.

Product ID75834-199_c41b0332-f580-4927-8621-9af1452f8ac6
NDC75834-199
Product TypeHuman Prescription Drug
Proprietary NameOFLOXACIN
Generic NameOfloxacin
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2019-01-25
Marketing CategoryANDA / ANDA
Application NumberANDA091656
Labeler NameNivagen Pharmaceuticals, Inc.
Substance NameOFLOXACIN
Active Ingredient Strength200 mg/1
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 75834-199-05

500 TABLET, COATED in 1 BOTTLE (75834-199-05)
Marketing Start Date2019-01-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75834-199-01 [75834019901]

OFLOXACIN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091656
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-25

NDC 75834-199-50 [75834019950]

OFLOXACIN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091656
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-25

NDC 75834-199-05 [75834019905]

OFLOXACIN TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091656
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-25

Drug Details

Active Ingredients

IngredientStrength
OFLOXACIN200 mg/1

OpenFDA Data

SPL SET ID:1779c568-d7bb-4bd5-bc29-13bd52ba8a0a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198048
  • 198049
  • 198050
  • UPC Code
  • 0375834200507
  • 0375834201504
  • Pharmacological Class

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