NDC 0168-0275

Metronidazole

Metronidazole

Metronidazole is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Fougera Pharmaceuticals Inc.. The primary component is Metronidazole.

Product ID0168-0275_b5c8edbe-eed2-40ef-8426-f128363aad58
NDC0168-0275
Product TypeHuman Prescription Drug
Proprietary NameMetronidazole
Generic NameMetronidazole
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2006-06-06
Marketing CategoryANDA / ANDA
Application NumberANDA077018
Labeler NameFougera Pharmaceuticals Inc.
Substance NameMETRONIDAZOLE
Active Ingredient Strength8 mg/g
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0168-0275-45

1 TUBE in 1 CARTON (0168-0275-45) > 45 g in 1 TUBE
Marketing Start Date2006-06-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0275-45 [00168027545]

Metronidazole GEL
Marketing CategoryANDA
Application NumberANDA077018
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2006-06-06

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE7.5 mg/g

OpenFDA Data

SPL SET ID:ab766931-e685-4a81-9939-06da80d9099e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311679
    • UPC Code
  • 0301680275451

    • 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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