NDC 63347-503

TINEACIDE ANTIFUNGAL MAXIMUM STRENGTH

Miconazole Nitrate

TINEACIDE ANTIFUNGAL MAXIMUM STRENGTH is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Blaine Labs Inc.. The primary component is Miconazole Nitrate.

Product ID63347-503_14b7b389-6598-4246-875e-9c225d181282
NDC63347-503
Product TypeHuman Otc Drug
Proprietary NameTINEACIDE ANTIFUNGAL MAXIMUM STRENGTH
Generic NameMiconazole Nitrate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2019-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333C
Labeler NameBlaine Labs Inc.
Substance NameMICONAZOLE NITRATE
Active Ingredient Strength1 g/35g
Pharm ClassesAzole Antifungal [EPC], Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63347-503-01

1 BOTTLE in 1 BOX (63347-503-01) > 35 g in 1 BOTTLE
Marketing Start Date2019-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63347-503-01 [63347050301]

TINEACIDE ANTIFUNGAL MAXIMUM STRENGTH CREAM
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-03-01

Drug Details

Active Ingredients

IngredientStrength
MICONAZOLE NITRATE.7 g/35g

OpenFDA Data

SPL SET ID:b328a052-7456-4e34-b9ed-4c4219ff0451
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 998483

    • NDC Crossover Matching brand name "TINEACIDE ANTIFUNGAL MAXIMUM STRENGTH" or generic name "Miconazole Nitrate"

    NDCBrand NameGeneric Name
    63347-503TINEACIDE ANTIFUNGAL MAXIMUM STRENGTHTINEACIDE ANTIFUNGAL MAXIMUM STRENGTH
    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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