NDC 69007-835

Metronidazole Topical Gel

Metronidazole

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

Product ID69007-835_960347a4-11bd-4c23-84a8-d4a3d9eafe1d
NDC69007-835
Product TypeHuman Prescription Drug
Proprietary NameMetronidazole Topical Gel
Generic NameMetronidazole
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2014-03-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA019737
Labeler NameOwen Laboratories
Substance NameMETRONIDAZOLE
Active Ingredient Strength8 mg/g
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 69007-835-45

1 TUBE in 1 CARTON (69007-835-45) > 45 g in 1 TUBE
Marketing Start Date2014-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69007-835-45 [69007083545]

Metronidazole Topical Gel GEL
Marketing CategoryNDA authorized generic
Application NumberNDA019737
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2014-03-01
Marketing End Date2017-12-31

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE7.5 mg/g

OpenFDA Data

SPL SET ID:35bbbdc7-a8c5-4207-b671-2b1d2920df93
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311679

    • Pharmacological Class

    • Nitroimidazole Antimicrobial [EPC]
    • Nitroimidazoles [CS]

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

    NDCBrand NameGeneric Name
    69007-835Metronidazole Topical GelMetronidazole Topical Gel
    66993-962Metronidazole Topical GelMetronidazole Topical Gel
    0025-1821FlagylMetronidazole
    0025-1831FlagylMetronidazole
    0025-1942Flagylmetronidazole
    0299-3836MetroCreammetronidazole
    0299-3820METROGELmetronidazole
    0299-3838MetroLotionmetronidazole
    0115-1474MetronidazoleMetronidazole
    0143-9772MetronidazoleMetronidazole
    0168-0275MetronidazoleMetronidazole
    0168-0323MetronidazoleMetronidazole
    0168-0383MetronidazoleMetronidazole
    0179-1482MetronidazoleMetronidazole
    0264-5535METRONIDAZOLEMETRONIDAZOLE
    0338-1055MetronidazoleMetronidazole
    0187-5202Noritatemetronidazole
    0245-0860VandazoleMetronidazole
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