NDC 15955-389

Metronidazole

Metronidazole

Metronidazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Alembic Labs Llc. The primary component is Metronidazole.

Product ID15955-389_4bc960cb-872d-43da-81eb-0dbb058cfaad
NDC15955-389
Product TypeHuman Prescription Drug
Proprietary NameMetronidazole
Generic NameMetronidazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-06-26
Marketing CategoryANDA / ANDA
Application NumberANDA208681
Labeler NameAlembic Labs LLC
Substance NameMETRONIDAZOLE
Active Ingredient Strength500 mg/1
Pharm ClassesNitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 15955-389-01

100 TABLET in 1 BOTTLE (15955-389-01)
Marketing Start Date2019-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 15955-389-05 [15955038905]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA208681
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-26

NDC 15955-389-01 [15955038901]

Metronidazole TABLET
Marketing CategoryANDA
Application NumberANDA208681
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-26

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE500 mg/1

OpenFDA Data

SPL SET ID:86415209-5440-41da-abb8-e1a3d5051f91
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311681
  • 314106
    • UPC Code
  • 0315955388012
  • 0315955389019

    • Pharmacological Class

    • Nitroimidazole Antimicrobial [EPC]
    • Nitroimidazoles [CS]
    • Nitroimidazole Antimicrobial [EPC]
    • Nitroimidazoles [CS]

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

    NDCBrand NameGeneric Name
    0115-1474MetronidazoleMetronidazole
    0143-9772MetronidazoleMetronidazole
    0168-0275MetronidazoleMetronidazole
    0168-0323MetronidazoleMetronidazole
    0168-0383MetronidazoleMetronidazole
    0179-1482MetronidazoleMetronidazole
    0264-5535METRONIDAZOLEMETRONIDAZOLE
    0338-1055MetronidazoleMetronidazole
    68001-364MetronidazoleMetronidazole
    68001-229MetronidazoleMetronidazole
    68001-365MetronidazoleMetronidazole
    68001-263MetronidazoleMetronidazole
    68071-1753MetronidazoleMetronidazole
    68071-2196MetronidazoleMetronidazole
    68071-1939MetronidazoleMetronidazole
    68071-1876MetronidazoleMetronidazole
    0409-7811MetronidazoleMetronidazole
    68071-3039MetronidazoleMetronidazole
    68084-966MetronidazoleMetronidazole
    0440-1795MetronidazoleMetronidazole
    68084-216MetronidazoleMetronidazole
    0440-1796MetronidazoleMetronidazole
    68151-2007MetronidazoleMetronidazole
    68382-850metronidazolemetronidazole
    68382-851metronidazolemetronidazole
    68682-455MetronidazoleMetronidazole
    68788-6843MetronidazoleMetronidazole
    68788-6930MetronidazoleMetronidazole
    68788-9082MetronidazoleMetronidazole
    68788-6960MetronidazoleMetronidazole
    68788-9505MetronidazoleMetronidazole
    68788-9372MetronidazoleMetronidazole
    68788-9397MetronidazoleMetronidazole
    68788-8930MetronidazoleMetronidazole
    68788-9083MetronidazoleMetronidazole
    68788-7381MetronidazoleMetronidazole
    69007-836METRONIDAZOLEMETRONIDAZOLE
    69043-004MetronidazoleMetronidazole
    69043-005MetronidazoleMetronidazole
    69292-206metronidazolemetronidazole
    70518-0090MetronidazoleMetronidazole
    70518-0058MetronidazoleMetronidazole
    70518-0013MetronidazoleMetronidazole
    70518-0324MetronidazoleMetronidazole
    70518-0088MetronidazoleMetronidazole
    70518-0539MetronidazoleMetronidazole
    0591-2521MetronidazoleMetronidazole
    70518-0797MetronidazoleMetronidazole
    70518-1536MetronidazoleMetronidazole
    0591-5215MetronidazoleMetronidazole
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