NDC 59390-140

Ofloxacin ophthalmic

Ofloxacin

Ofloxacin ophthalmic is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Altaire Pharmaceuticals Inc.. The primary component is Ofloxacin.

Product ID59390-140_28125c1a-d1b0-4763-9b5e-07b4cfc2d889
NDC59390-140
Product TypeHuman Prescription Drug
Proprietary NameOfloxacin ophthalmic
Generic NameOfloxacin
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2013-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA202692
Labeler NameAltaire Pharmaceuticals Inc.
Substance NameOFLOXACIN
Active Ingredient Strength3 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC], Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59390-140-05

5 mL in 1 BOTTLE, DROPPER (59390-140-05)
Marketing Start Date2013-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59390-140-05 [59390014005]

Ofloxacin ophthalmic SOLUTION
Marketing CategoryANDA
Application NumberANDA202692
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-05-31

Drug Details

Active Ingredients

IngredientStrength
OFLOXACIN3 mg/mL

OpenFDA Data

SPL SET ID:fe564e33-8f5d-4b57-87a9-7afae02eaf97
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312075

    • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

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

    NDCBrand NameGeneric Name
    59390-140Ofloxacin ophthalmicOfloxacin ophthalmic
    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
    50383-024OfloxacinOfloxacin
    50090-1090Ofloxacin OticOfloxacin
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