NDC 53217-347

Moxifloxacin

Moxifloxacin

Moxifloxacin is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Moxifloxacin Hydrochloride Monohydrate.

Product ID53217-347_b1bd6471-c51c-49b5-86b4-89bf059208fc
NDC53217-347
Product TypeHuman Prescription Drug
Proprietary NameMoxifloxacin
Generic NameMoxifloxacin
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2017-11-28
Marketing CategoryANDA / ANDA
Application NumberANDA090080
Labeler NameAidarex Pharmaceuticals LLC
Substance NameMOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
Active Ingredient Strength5 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-347-01

3 mL in 1 BOTTLE, DROPPER (53217-347-01)
Marketing Start Date2017-11-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-347-01 [53217034701]

Moxifloxacin SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA090080
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE5 mg/mL

OpenFDA Data

SPL SET ID:688feb67-9254-4537-b749-9d591fef5637
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403818

    • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

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

    NDCBrand NameGeneric Name
    0378-5430Moxifloxacinmoxifloxacin
    0904-6406MoxifloxacinMoxifloxacin
    16714-643MOXIFLOXACINMOXIFLOXACIN
    17478-519MoxifloxacinMoxifloxacin
    48792-7823Moxifloxacinmoxifloxacin hydrochloride
    50090-3091Moxifloxacinmoxifloxacin
    50090-3147MoxifloxacinMoxifloxacin
    50090-5279MoxifloxacinMoxifloxacin
    53217-347Moxifloxacinmoxifloxacin
    55111-112MoxifloxacinMoxifloxacin
    55700-638MoxifloxacinMoxifloxacin
    55700-657MoxifloxacinMoxifloxacin
    60505-0582Moxifloxacinmoxifloxacin
    61919-553MOXIFLOXACINMOXIFLOXACIN
    63323-850MoxifloxacinMOXIFLOXACIN HYDROCHLORIDE
    63629-8357MoxifloxacinMoxifloxacin
    65862-840MOXIFLOXACINMOXIFLOXACIN
    66298-8507MoxifloxacinMOXIFLOXACIN HYDROCHLORIDE
    67296-1679MoxifloxacinMoxifloxacin
    68180-421MOXIFLOXACINMOXIFLOXACIN
    68180-422MoxifloxacinMoxifloxacin
    68788-7404Moxifloxacinmoxifloxacin
    72189-076MOXIFLOXACINMOXIFLOXACIN
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