NDC 0781-7135

Moxifloxacin Ophthalmic Solution

Moxifloxacin Hydrochloride

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

Product ID0781-7135_479f3c7c-8d44-49de-9324-2788da6214d4
NDC0781-7135
Product TypeHuman Prescription Drug
Proprietary NameMoxifloxacin Ophthalmic Solution
Generic NameMoxifloxacin Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2003-05-07
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021598
Labeler NameSandoz Inc
Substance NameMOXIFLOXACIN HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0781-7135-93

1 BOTTLE, PLASTIC in 1 CARTON (0781-7135-93) > 3 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2017-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-7135-93 [00781713593]

Moxifloxacin Ophthalmic Solution SOLUTION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA021598
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-30
Inactivation Date2020-01-31
Reactivation Date2020-02-28

Drug Details

Active Ingredients

IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:fc88791b-24da-48a4-85f5-93a8af3d0b51
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 Hydrochloride"

    NDCBrand NameGeneric Name
    0781-7135Moxifloxacin Ophthalmic Solutionmoxifloxacin hydrochloride
    62332-505Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmic solution
    50090-4781Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmic solution
    68083-210Moxifloxacin Ophthalmic SolutionMoxifloxacin Ophthalmic Solution
    53002-2626Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmic solution
    72266-158Moxifloxacin Ophthalmic SolutionMoxifloxacin Ophthalmic Solution
    0085-1733Aveloxmoxifloxacin hydrochloride
    0085-1737Aveloxmoxifloxacin hydrochloride
    0065-0006MOXEZAmoxifloxacin hydrochloride
    48792-7823Moxifloxacinmoxifloxacin hydrochloride
    0093-7387Moxifloxacin HydrochlorideMoxifloxacin Hydrochloride
    0832-1410Moxifloxacin HydrochlorideMoxifloxacin Hydrochloride
    13668-201moxifloxacin hydrochloridemoxifloxacin hydrochloride
    40032-034Moxifloxacin HydrochlorideMoxifloxacin Hydrochloride
    43063-580Moxifloxacin Hydrochloridemoxifloxacin hydrochloride
    43063-585Moxifloxacin Hydrochloridemoxifloxacin hydrochloride
    47781-268Moxifloxacin Hydrochloridemoxifloxacin hydrochloride
    50090-4058Moxifloxacin HydrochlorideMoxifloxacin Hydrochloride
    50090-4100Moxifloxacin HydrochlorideMoxifloxacin Hydrochloride
    0065-4013VIGAMOXmoxifloxacin hydrochloride
    0078-0939VIGAMOXmoxifloxacin hydrochloride
    21695-968VIGAMOXmoxifloxacin hydrochloride
    50090-0859VIGAMOXmoxifloxacin hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.