NDC 50382-004

Antifungal

Antifungal

Antifungal is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Galentic Pharma (india) Priva Te Limited. The primary component is Clotrimazole.

Product ID50382-004_64c54ba8-05dd-48a2-b8c3-c26d7f869233
NDC50382-004
Product TypeHuman Otc Drug
Proprietary NameAntifungal
Generic NameAntifungal
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-08-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333C
Labeler NameGalentic Pharma (India) Priva Te Limited
Substance NameCLOTRIMAZOLE
Active Ingredient Strength1 g/100g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 50382-004-02

113 g in 1 TUBE (50382-004-02)
Marketing Start Date2013-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50382-004-02 [50382000402]

Antifungal CREAM
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-08-07
Inactivation Date2019-11-27

NDC 50382-004-01 [50382000401]

Antifungal CREAM
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-08-07
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
CLOTRIMAZOLE1 g/100g

OpenFDA Data

SPL SET ID:7c48c331-adb8-4e9e-b6b9-e633b5188189
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309367
  • NDC Crossover Matching brand name "Antifungal" or generic name "Antifungal"

    NDCBrand NameGeneric Name
    0472-0735AntifungalMiconazole Nitrate
    11822-0154antifungaltolnaftate
    11822-0351AntifungalClotrimazole
    11822-0539antifungalTolnaftate
    11822-3078AntifungalClotrimazole
    41250-080AntifungalTerbinafine Hydrochloride
    50090-1351AntifungalMiconazole Nitrate
    50090-2231AntifungalMiconazole Nitrate
    50090-2718AntifungalMiconazole Nitrate
    50382-004AntifungalAntifungal
    55670-602Antifungaltolnaftate
    63187-885Antifungalmiconazole nitrate
    63347-200AntifungalUNDECYLENIC ACID
    63868-685AntifungalTolnaftate 1%
    68345-817AntifungalMiconazole Nitrate
    68599-1470AntifungalMiconazole Nitrate
    68788-7374AntifungalAntifungal
    70000-0040AntifungalAntifungal
    68001-475Antifungal Creamantifungal
    68001-478Antifungal Creamantifungal
    68001-481Antifungal Creamantifungal
    61767-231Blossom Pharmaceuticals Antifungalantifungal
    67777-231Dynarex Antifungalantifungal
    50382-050MICONAZOLEantifungal
    55681-165Miconazole nitrateAntifungal

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.