NDC 55379-406

CortiSil MDX

Hydrocortisone Acetate

CortiSil MDX is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Biozone Laboratories,inc.. The primary component is Hydrocortisone Acetate.

Product ID55379-406_008a5dc6-136b-4809-bec6-0a7ecf1f3981
NDC55379-406
Product TypeHuman Otc Drug
Proprietary NameCortiSil MDX
Generic NameHydrocortisone Acetate
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2013-03-25
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart348
Labeler NameBioZone Laboratories,Inc.
Substance NameHYDROCORTISONE ACETATE
Active Ingredient Strength1 g/100g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 55379-406-01

1 BOTTLE, PUMP in 1 CARTON (55379-406-01) > 30 g in 1 BOTTLE, PUMP
Marketing Start Date2013-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55379-406-01 [55379040601]

CortiSil MDX GEL
Marketing CategoryOTC monograph final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-03-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE1 g/100g

OpenFDA Data

SPL SET ID:008a5dc6-136b-4809-bec6-0a7ecf1f3981
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1235742
  • 1373239
  • NDC Crossover Matching brand name "CortiSil MDX" or generic name "Hydrocortisone Acetate"

    NDCBrand NameGeneric Name
    55379-406CortiSil MDXCortiSil MDX
    0316-0140Ala ScalpHydrocortisone Acetate
    0713-0503ANUCORT-HCHydrocortisone Acetate
    43474-000bioCorneum HC Advanced Scar Supervision Anti-ItchHYDROCORTISONE ACETATE
    49825-126BioelementsHydrocortisone Acetate
    0037-6830Cortifoamhydrocortisone acetate
    16477-201Hemmorex-HChydrocortisone acetate
    16477-202Hemmorex-HChydrocortisone acetate
    0363-0972HydrocortisoneHydrocortisone Acetate
    11822-2069HydrocortisoneHydrocortisone Acetate
    0574-7090Hydrocortisone AcetateHYDROCORTISONE ACETATE
    0574-7093Hydrocortisone AcetateHYDROCORTISONE ACETATE
    0713-0493Hydrocortisone AcetateHYDROCORTISONE ACETATE
    10135-751Hydrocortisone AcetateHydrocortisone Acetate
    16571-676Hydrocortisone AcetateHydrocortisone Acetate
    24689-102Hydrocortisone AcetateHydrocortisone Acetate
    24689-103Hydrocortisone AcetateHydrocortisone Acetate
    39328-029Hydrocortisone AcetateHydrocortisone Acetate
    39328-129Hydrocortisone AcetateHydrocortisone Acetate
    42494-301Hydrocortisone AcetateHYDROCORTISONE ACETATE
    42494-302Hydrocortisone AcetateHYDROCORTISONE ACETATE
    42494-341Hydrocortisone AcetateHydrocortisone Acetate
    42494-342Hydrocortisone AcetateHydrocortisone Acetate
    47832-205Hydrocortisone AcetateHydrocortisone Acetate
    0179-8710KAISER PERMANENTEHydrocortisone acetate
    47682-923Medi-First 1% HydrocortisoneHydrocortisone acetate
    47682-207Medi-First Hydrocortisone 1%Hydrocortisone acetate
    15014-185NuCortHydrocortisone Acetate
    11509-5101Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin FormulaHydrocortisone Acetate

    Trademark Results [CortiSil MDX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CORTISIL MDX
    CORTISIL MDX
    85686544 not registered Dead/Abandoned
    Crescendo Therapeutics LLC
    2012-07-25

    © 2022 FDA.report
    This site is not affiliated with or endorsed by the FDA.