NDC 70518-0058

Metronidazole

Metronidazole

Metronidazole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Metronidazole.

Product ID70518-0058_80129493-1088-3246-e053-2991aa0adb0e
NDC70518-0058
Product TypeHuman Prescription Drug
Proprietary NameMetronidazole
Generic NameMetronidazole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-12-13
Marketing CategoryANDA / ANDA
Application NumberANDA203458
Labeler NameREMEDYREPACK INC.
Substance NameMETRONIDAZOLE
Active Ingredient Strength500 mg/1
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0058-0

14 TABLET, FILM COATED in 1 BOTTLE (70518-0058-0)
Marketing Start Date2016-12-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0058-0 [70518005800]

Metronidazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203458
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-13

NDC 70518-0058-4 [70518005804]

Metronidazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203458
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-25
Marketing End Date2020-04-15

NDC 70518-0058-1 [70518005801]

Metronidazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203458
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-10

NDC 70518-0058-3 [70518005803]

Metronidazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203458
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-12

NDC 70518-0058-2 [70518005802]

Metronidazole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203458
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-13

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE500 mg/1

OpenFDA Data

SPL SET ID:49bed450-7fa8-401c-8c8c-afc1c61d473a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311681

    • Pharmacological Class

    • 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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