NDC 63736-025

Monistat 7 with Reusable Applicator

Miconazole Nitrate

Monistat 7 with Reusable Applicator is a Vaginal Cream in the Human Otc Drug category. It is labeled and distributed by Insight Pharmaceuticals Llc. The primary component is Miconazole Nitrate.

Product ID63736-025_1cac7cc9-d11d-4e79-8174-d4c13b96bca7
NDC63736-025
Product TypeHuman Otc Drug
Proprietary NameMonistat 7 with Reusable Applicator
Generic NameMiconazole Nitrate
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date1993-04-26
Marketing CategoryNDA / NDA
Application NumberNDA017450
Labeler NameInsight Pharmaceuticals LLC
Substance NameMICONAZOLE NITRATE
Active Ingredient Strength20 mg/g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63736-025-15

1 TUBE, WITH APPLICATOR in 1 CARTON (63736-025-15) > 45 g in 1 TUBE, WITH APPLICATOR
Marketing Start Date1993-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63736-025-15 [63736002515]

Monistat 7 with Reusable Applicator CREAM
Marketing CategoryNDA
Application NumberNDA017450
Product TypeHUMAN OTC DRUG
Marketing Start Date1993-04-26
Inactivation Date2020-01-31
Reactivation Date2020-04-08

Drug Details

Active Ingredients

IngredientStrength
MICONAZOLE NITRATE20 mg/g

OpenFDA Data

SPL SET ID:2aad40f2-4eea-441d-8b34-5613f1955405
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 998541
  • 998540

    • NDC Crossover Matching brand name "Monistat 7 with Reusable Applicator" or generic name "Miconazole Nitrate"

    NDCBrand NameGeneric Name
    63736-025Monistat 7 with Reusable ApplicatorMonistat 7 with Reusable Applicator
    0363-0557Athletes FootMiconazole Nitrate
    0113-7199Basic Care miconazole 1Miconazole nitrate
    0113-7070basic care miconazole 3miconazole nitrate
    0113-7825basic care miconazole 7Miconazole nitrate
    0067-0949DesenexMICONAZOLE NITRATE
    0316-0225DesenexMICONAZOLE NITRATE
    0113-0916good sense miconazole 1Miconazole nitrate
    0113-9001good sense miconazole 1Miconazole nitrate
    0113-0081Good Sense Miconazole 3Miconazole nitrate
    0113-0214Good Sense Miconazole 7Miconazole nitrate
    0113-0825good sense miconazole 7Miconazole nitrate
    0179-8017Kaiser PermanenteMiconazole Nitrate
    0363-0199Miconazole 1Miconazole nitrate
    0363-0081Miconazole 3Miconazole nitrate
    0363-0637Miconazole 3Miconazole nitrate
    0363-0730Miconazole 7Miconazole Nitrate
    0067-2091Vagistat-3Miconazole nitrate
    0145-1501Zeasorbmiconazole nitrate
    0145-1506Zeasorbmiconazole nitrate
    0316-0231Zeasorbmiconazole nitrate
    0316-0232Zeasorbmiconazole nitrate
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