NDC 0168-0323

Metronidazole

Metronidazole

Metronidazole is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by E.fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Metronidazole.

Product ID0168-0323_5def698c-05fa-4681-8b56-59d6f587ca16
NDC0168-0323
Product TypeHuman Prescription Drug
Proprietary NameMetronidazole
Generic NameMetronidazole
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2004-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA076408
Labeler NameE.FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.
Substance NameMETRONIDAZOLE
Active Ingredient Strength8 mg/g
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0168-0323-46

45 g in 1 TUBE (0168-0323-46)
Marketing Start Date2004-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0323-46 [00168032346]

Metronidazole CREAM
Marketing CategoryANDA
Application NumberANDA076408
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2004-05-28

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE7.5 mg/g

OpenFDA Data

SPL SET ID:43ed872b-63ac-4a22-9c9e-cc0e05bcc41e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311678
    • UPC Code
  • 0301680323466

    • 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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