NDC 68788-8985

Miconazole Nitrate

Miconazole Nitrate

Miconazole Nitrate is a Vaginal Cream in the Human Otc Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Miconazole Nitrate.

Product ID68788-8985_a7e286a7-d75a-4232-8b2e-c9e7f071b595
NDC68788-8985
Product TypeHuman Otc Drug
Proprietary NameMiconazole Nitrate
Generic NameMiconazole Nitrate
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2016-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA074444
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameMICONAZOLE NITRATE
Active Ingredient Strength20 mg/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68788-8985-4

45 g in 1 TUBE, WITH APPLICATOR (68788-8985-4)
Marketing Start Date2016-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-8985-4 [68788898504]

Miconazole Nitrate CREAM
Marketing CategoryANDA
Application NumberANDA074444
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-01
Marketing End Date2019-10-30

Drug Details

Active Ingredients

IngredientStrength
MICONAZOLE NITRATE20 mg/g

OpenFDA Data

SPL SET ID:f8a4641d-8a22-4900-9a4a-46bee0f72281
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 998540
  • NDC Crossover Matching brand name "Miconazole Nitrate" or generic name "Miconazole Nitrate"

    NDCBrand NameGeneric Name
    0113-0136Miconazole nitrateAntifungal Miconazole Liquid Continuous Spray
    68016-516Miconazole NitrateMiconazole Nitrate
    68016-673Miconazole NitrateMiconazole Nitrate
    68016-648Miconazole NitrateMiconazole Nitrate
    0472-1738Miconazole NitrateMiconazole Nitrate
    68788-0344Miconazole NitrateMiconazole Nitrate
    68788-8985Miconazole NitrateMiconazole Nitrate
    69256-039Miconazole NitrateMiconazole Nitrate
    69256-032Miconazole NitrateMiconazole Nitrate
    69256-033Miconazole NitrateMiconazole Nitrate
    69256-038Miconazole NitrateMiconazole Nitrate
    0536-1134Miconazole NitrateMiconazole Nitrate
    69842-511Miconazole NitrateMiconazole Nitrate
    69842-490Miconazole NitrateMiconazole Nitrate
    69842-502Miconazole NitrateMiconazole Nitrate
    69842-501Miconazole NitrateMiconazole Nitrate
    70000-0323Miconazole NitrateMiconazole Nitrate
    70000-0321Miconazole NitrateMiconazole Nitrate
    70403-924Miconazole NitrateMiconazole Nitrate
    70518-0811Miconazole NitrateMiconazole Nitrate
    72446-007Miconazole NitrateMiconazole Nitrate
    72570-104MICONAZOLE NITRATEMICONAZOLE NITRATE
    76413-318Miconazole NitrateMiconazole Nitrate
    0713-0197Miconazole NitrateMiconazole Nitrate
    0713-0252Miconazole NitrateMiconazole Nitrate
    11822-0122Miconazole NitrateMiconazole Nitrate
    11822-0135Miconazole NitrateMiconazole Nitrate
    15127-091Miconazole NitrateMiconazole Nitrate
    21695-854Miconazole NitrateMiconazole Nitrate
    30142-142Miconazole NitrateMiconazole Nitrate
    30142-135Miconazole NitrateMiconazole Nitrate
    36800-384Miconazole NitrateMiconazole Nitrate
    36800-385Miconazole NitrateMiconazole Nitrate
    36800-026Miconazole NitrateMiconazole Nitrate
    37808-520Miconazole NitrateMiconazole Nitrate
    41250-242Miconazole NitrateMiconazole Nitrate
    41250-196Miconazole NitrateMiconazole Nitrate
    41250-575Miconazole NitrateMiconazole Nitrate
    41250-098Miconazole nitrateMiconazole nitrate
    41520-087Miconazole NitrateMiconazole Nitrate
    41520-565Miconazole NitrateMiconazole Nitrate
    41520-088Miconazole NitrateMiconazole Nitrate
    41520-566Miconazole NitrateMiconazole Nitrate
    42254-319Miconazole NitrateMiconazole Nitrate
    42254-295Miconazole NitrateMiconazole Nitrate
    46122-039Miconazole NitrateMiconazole Nitrate
    46122-444Miconazole NitrateMiconazole Nitrate
    49035-339Miconazole NitrateMiconazole Nitrate
    49035-135Miconazole NitrateMiconazole Nitrate
    50090-0462Miconazole NitrateMiconazole Nitrate

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