NDC 58980-818

Azolen

Miconazole Nitrate

Azolen is a Topical Tincture in the Human Otc Drug category. It is labeled and distributed by Stratus Pharmaceuticals, Inc.. The primary component is Miconazole Nitrate.

Product ID58980-818_fa7abfcb-49d5-412f-88ab-68af39fd0f5d
NDC58980-818
Product TypeHuman Otc Drug
Proprietary NameAzolen
Generic NameMiconazole Nitrate
Dosage FormTincture
Route of AdministrationTOPICAL
Marketing Start Date2017-09-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333C
Labeler NameStratus Pharmaceuticals, Inc.
Substance NameMICONAZOLE NITRATE
Active Ingredient Strength20 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58980-818-10

1 BOTTLE, WITH APPLICATOR in 1 BOX (58980-818-10) > 29.57 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date2017-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58980-818-10 [58980081810]

Azolen TINCTURE
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2017-09-15

Drug Details

Active Ingredients

IngredientStrength
MICONAZOLE NITRATE20 mg/mL

OpenFDA Data

SPL SET ID:9c2574f3-3be4-405a-9c87-943dc6ef8777
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 998525
    • UPC Code
  • 0358980818109

    • NDC Crossover Matching brand name "Azolen" or generic name "Miconazole Nitrate"

    NDCBrand NameGeneric Name
    58980-818AzolenAzolen
    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 [Azolen]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AZOLEN
    AZOLEN
    98513961 not registered Live/Pending
    Stratus Pharmaceuticals, Inc.
    2024-04-23
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