NDC 50383-189

Gatifloxacin

Gatifloxacin

Gatifloxacin is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Gatifloxacin Anhydrous.

Product ID50383-189_2145dbd3-6bcf-4473-b30b-7ad660f83cad
NDC50383-189
Product TypeHuman Prescription Drug
Proprietary NameGatifloxacin
Generic NameGatifloxacin
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-10-06
Marketing CategoryANDA / ANDA
Application NumberANDA203189
Labeler NameAkorn
Substance NameGATIFLOXACIN ANHYDROUS
Active Ingredient Strength5 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC], Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50383-189-02

1 BOTTLE, DROPPER in 1 CARTON (50383-189-02) > 2.5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2014-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-189-02 [50383018902]

Gatifloxacin SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA203189
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-10-06

Drug Details

Active Ingredients

IngredientStrength
GATIFLOXACIN ANHYDROUS5 mg/mL

OpenFDA Data

SPL SET ID:14312de6-67d4-4de2-854c-ef764090dd83
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992395
  • Pharmacological Class

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

    Medicade Reported Pricing

    50383018902 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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