NDC 55315-737

Freds Miconazole 3

Miconazole Nitrate

Freds Miconazole 3 is a Vaginal Cream in the Human Otc Drug category. It is labeled and distributed by Fred's, Inc.. The primary component is Miconazole Nitrate.

Product ID55315-737_4c5dc483-ffb4-4a86-bdd1-dbfef0d41a26
NDC55315-737
Product TypeHuman Otc Drug
Proprietary NameFreds Miconazole 3
Generic NameMiconazole Nitrate
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2005-03-02
Marketing CategoryANDA / ANDA
Application NumberANDA076773
Labeler NameFRED'S, INC.
Substance NameMICONAZOLE NITRATE
Active Ingredient Strength40 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55315-737-43

1 TUBE, WITH APPLICATOR in 1 CARTON (55315-737-43) > 25 g in 1 TUBE, WITH APPLICATOR
Marketing Start Date2018-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55315-737-43 [55315073743]

Freds Miconazole 3 CREAM
Marketing CategoryANDA
Application NumberANDA076773
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-20

Drug Details

Active Ingredients

IngredientStrength
MICONAZOLE NITRATE40 mg/g

OpenFDA Data

SPL SET ID:35bd36ef-1bf5-480c-9a5b-7faf4c935476
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 998544

    • NDC Crossover Matching brand name "Freds Miconazole 3" or generic name "Miconazole Nitrate"

    NDCBrand NameGeneric Name
    55315-737Freds Miconazole 3Freds Miconazole 3
    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 [Freds]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FREDS
    FREDS
    88796457 not registered Live/Pending
    ABG-Barneys, LLC
    2020-02-13
    FREDS
    FREDS
    88158176 5928252 Live/Registered
    Shipyard Brewing Company, LLC
    2018-10-17
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.