NDC 68083-210

Moxifloxacin Ophthalmic Solution

Moxifloxacin Ophthalmic

Moxifloxacin Ophthalmic Solution is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Moxifloxacin Hydrochloride.

Product ID68083-210_1762525e-0af9-445f-ab67-00bfa954dc7d
NDC68083-210
Product TypeHuman Prescription Drug
Proprietary NameMoxifloxacin Ophthalmic Solution
Generic NameMoxifloxacin Ophthalmic
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2020-03-30
Marketing CategoryANDA / ANDA
Application NumberANDA208778
Labeler NameGland Pharma Limited
Substance NameMOXIFLOXACIN HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68083-210-01

1 BOTTLE, PLASTIC in 1 CARTON (68083-210-01) > 3 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2020-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-210-01 [68083021001]

Moxifloxacin Ophthalmic Solution SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA208778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-30

Drug Details

Active Ingredients

IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:95773bca-0791-4bfe-955a-4d2fa4561e01
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403818

    • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

    NDC Crossover Matching brand name "Moxifloxacin Ophthalmic Solution" or generic name "Moxifloxacin Ophthalmic"

    NDCBrand NameGeneric Name
    0781-7135Moxifloxacin Ophthalmic Solutionmoxifloxacin hydrochloride
    50090-4781Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmic
    53002-2626Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmic
    62332-505Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmic solution
    68083-210Moxifloxacin Ophthalmic SolutionMoxifloxacin Ophthalmic
    72266-158Moxifloxacin Ophthalmic SolutionMoxifloxacin Ophthalmic
    50090-6248Moxifloxacin OphthalmicMoxifloxacin Ophthalmic
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