NDC 61715-050

MICONAZOLE

Miconazole

MICONAZOLE is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Kinray, Inc.. The primary component is Miconazole Nitrate.

Product ID61715-050_560c02ad-d329-4458-a761-c50d8b737d69
NDC61715-050
Product TypeHuman Otc Drug
Proprietary NameMICONAZOLE
Generic NameMiconazole
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-03-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333C
Labeler NameKinray, Inc.
Substance NameMICONAZOLE NITRATE
Active Ingredient Strength20 mg/g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 61715-050-01

28.4 g in 1 TUBE (61715-050-01)
Marketing Start Date2013-03-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61715-050-01 [61715005001]

MICONAZOLE CREAM
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-03-22
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MICONAZOLE NITRATE20 mg/g

OpenFDA Data

SPL SET ID:a44c3b24-dae2-4993-a49f-71e4eb63b231
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 998483
  • NDC Crossover Matching brand name "MICONAZOLE" or generic name "Miconazole"

    NDCBrand NameGeneric Name
    37808-928Miconazolemiconazole nitrate
    50382-050MICONAZOLEantifungal
    61715-050MICONAZOLEMICONAZOLE
    68016-291MiconazoleMiconazole Nitrate
    67777-316Dynarex Antifungal PowderMiconazole
    69020-208MakeSenseMiconazole
    42669-073Miconazole Foot PowderMiconazole
    61825-303OravigMiconazole
    89141-250ORAVIGmiconazole
    15071-804Rash Relief AntifungalMiconazole

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