NDC 68180-435

Gatifloxacin

Gatifloxacin

Gatifloxacin is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Gatifloxacin.

Product ID68180-435_0f7cdd76-0899-446d-945e-9b81a0dc6fd8
NDC68180-435
Product TypeHuman Prescription Drug
Proprietary NameGatifloxacin
Generic NameGatifloxacin
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2013-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA202653
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameGATIFLOXACIN
Active Ingredient Strength5 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68180-435-01

1 BOTTLE in 1 CARTON (68180-435-01) > 2.5 mL in 1 BOTTLE
Marketing Start Date2013-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-435-01 [68180043501]

Gatifloxacin SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA202653
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-10-01

Drug Details

Active Ingredients

IngredientStrength
GATIFLOXACIN5 mg/mL

OpenFDA Data

SPL SET ID:3deb52f2-0580-45ac-9bbd-c0c9e3f13a37
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992395

    • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

    Medicade Reported Pricing

    68180043501 GATIFLOXACIN 0.5% EYE DROPS

    Pricing Unit: ML | Drug Type:

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

    NDCBrand NameGeneric Name
    0378-5431Gatifloxacingatifloxacin
    13668-526GatifloxacinGatifloxacin
    50383-189GatifloxacinGatifloxacin
    57297-435GatifloxacinGatifloxacin
    60758-615gatifloxacingatifloxacin
    61314-672Gatifloxacingatifloxacin
    68180-435GatifloxacinGatifloxacin
    0023-3615ZYMAXIDgatifloxacin
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