NDC 61919-553

MOXIFLOXACIN

Moxifloxacin

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

Product ID61919-553_8385abd7-1529-0d7e-e053-2991aa0ac846
NDC61919-553
Product TypeHuman Prescription Drug
Proprietary NameMOXIFLOXACIN
Generic NameMoxifloxacin
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2018-07-30
Marketing CategoryANDA / ANDA
Application NumberANDA090080
Labeler NameDIRECT RX
Substance NameMOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
Active Ingredient Strength5 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-553-05

3 mL in 1 BOTTLE, DROPPER (61919-553-05)
Marketing Start Date2018-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-553-05 [61919055305]

MOXIFLOXACIN SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA090080
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-07-30

Drug Details

Active Ingredients

IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE5 mg/mL

OpenFDA Data

SPL SET ID:723771a2-3e9a-e6f3-e053-2a91aa0a4d21
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403818
  • Pharmacological Class

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