NDC 0187-5202

Noritate

Metronidazole

Noritate is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Metronidazole.

Product ID0187-5202_5a06234a-522d-4794-abff-b6484e89bb12
NDC0187-5202
Product TypeHuman Prescription Drug
Proprietary NameNoritate
Generic NameMetronidazole
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-08-09
Marketing CategoryNDA / NDA
Application NumberNDA020743
Labeler NameBausch Health US, LLC
Substance NameMETRONIDAZOLE
Active Ingredient Strength10 mg/60g
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0187-5202-60

60 g in 1 TUBE (0187-5202-60)
Marketing Start Date2013-08-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-5202-60 [00187520260]

Noritate CREAM
Marketing CategoryNDA
Application NumberNDA020743
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2013-08-09

NDC 0187-5202-35 [00187520235]

Noritate CREAM
Marketing CategoryNDA
Application NumberNDA020743
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-08-09

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE10 mg/60g

OpenFDA Data

SPL SET ID:706b09da-6cf9-421d-8e91-f3999474d322
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311680
  • 213120

    • Pharmacological Class

    • Nitroimidazole Antimicrobial [EPC]
    • Nitroimidazoles [CS]

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

    NDCBrand NameGeneric Name
    0187-5202Noritatemetronidazole
    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
    0245-0860VandazoleMetronidazole

    Trademark Results [Noritate]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NORITATE
    NORITATE
    75182296 2213312 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    1996-10-16
    NORITATE
    NORITATE
    72385453 0935930 Dead/Expired
    DERMIK LABORATORIES, INC.
    1971-03-04
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