NDC 0378-5431

Gatifloxacin

Gatifloxacin

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

Product ID0378-5431_6e7c741c-1750-4d2a-ba6c-f710be10a53b
NDC0378-5431
Product TypeHuman Prescription Drug
Proprietary NameGatifloxacin
Generic NameGatifloxacin
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-03-08
Marketing CategoryANDA / ANDA
Application NumberANDA206446
Labeler NameMylan Pharmaceuticals Inc.
Substance NameGATIFLOXACIN
Active Ingredient Strength5 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-5431-35

1 BOTTLE in 1 CARTON (0378-5431-35) > 2.5 mL in 1 BOTTLE
Marketing Start Date2019-03-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5431-35 [00378543135]

Gatifloxacin SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA206446
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-08

Drug Details

Active Ingredients

IngredientStrength
GATIFLOXACIN5 mg/mL

OpenFDA Data

SPL SET ID:6e7c741c-1750-4d2a-ba6c-f710be10a53b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992395
  • Pharmacological Class

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

    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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