NDC 63736-015

Monistat 3 3-Day Pre-filled Applicators

Miconazole Nitrate

Monistat 3 3-Day Pre-filled Applicators 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 ID63736-015_0da2b4b5-c6e5-4b78-bbc5-dd78005e3d4a
NDC63736-015
Product TypeHuman Otc Drug
Proprietary NameMonistat 3 3-Day Pre-filled Applicators
Generic NameMiconazole Nitrate
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date1998-03-30
Marketing CategoryNDA / NDA
Application NumberNDA020827
Labeler NameInsight Pharmaceuticals LLC
Substance NameMICONAZOLE NITRATE
Active Ingredient Strength40 mg/g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63736-015-18

3 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-18) > 5 g in 1 TUBE, WITH APPLICATOR
Marketing Start Date1998-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63736-015-18 [63736001518]

Monistat 3 3-Day Pre-filled Applicators CREAM
Marketing CategoryNDA
Application NumberNDA020827
Product TypeHUMAN OTC DRUG
Marketing Start Date1998-03-30
Inactivation Date2020-01-31
Reactivation Date2020-02-20

Drug Details

Active Ingredients

IngredientStrength
MICONAZOLE NITRATE40 mg/g

OpenFDA Data

SPL SET ID:f38c7e1d-2439-4b3b-8be8-60b2d8e61ce5
Manufacturer
UNII
UPC Code
  • 0363736442019

    • NDC Crossover Matching brand name "Monistat 3 3-Day Pre-filled Applicators" or generic name "Miconazole Nitrate"

    NDCBrand NameGeneric Name
    63736-015Monistat 3 3-Day Pre-filled ApplicatorsMonistat 3 3-Day Pre-filled Applicators
    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

    Trademark Results [Monistat 3]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MONISTAT 3
    MONISTAT 3
    75555891 2378593 Live/Registered
    Johnson & Johnson
    1998-09-21
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