NDC 43538-181

Rosadan

Metronidazole

Rosadan is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Medimetriks Pharmaceuticals, Inc.. The primary component is Metronidazole.

Product ID43538-181_4d930f1c-545f-4d1a-8917-6fa77b2db4a3
NDC43538-181
Product TypeHuman Prescription Drug
Proprietary NameRosadan
Generic NameMetronidazole
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2011-08-30
Marketing CategoryANDA / ANDA
Application NumberANDA077549
Labeler NameMedimetriks 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 43538-181-45

1 TUBE in 1 KIT (43538-181-45) > 45 g in 1 TUBE
Marketing Start Date2011-08-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43538-181-45 [43538018145]

Rosadan CREAM
Marketing CategoryANDA
Application NumberANDA077549
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-08-30

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE7.5 mg/g

OpenFDA Data

SPL SET ID:85a9ba62-eeb8-419e-a21f-e3db1eda7fc4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1148398
  • 311678

    • Pharmacological Class

    • Nitroimidazole Antimicrobial [EPC]
    • Nitroimidazoles [CS]

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

    NDCBrand NameGeneric Name
    43538-182RosadanRosadan
    43538-180RosadanRosadan
    43538-181RosadanRosadan
    43538-183RosadanRosadan
    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

    Trademark Results [Rosadan]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ROSADAN
    ROSADAN
    85178731 4084934 Live/Registered
    Medimetriks Pharmaceuticals, Inc.
    2010-11-17
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