NDC 10631-100

Exelderm

Sulconazole Nitrate

Exelderm is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Sulconazole Nitrate.

Product ID10631-100_4df88789-d3b0-4082-bb03-a12f9113d48b
NDC10631-100
Product TypeHuman Prescription Drug
Proprietary NameExelderm
Generic NameSulconazole Nitrate
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2009-04-08
Marketing End Date2020-06-30
Marketing CategoryNDA / NDA
Application NumberNDA018738
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameSULCONAZOLE NITRATE
Active Ingredient Strength10 mg/mL
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN

Packaging

NDC 10631-100-30

30 mL in 1 BOTTLE, PLASTIC (10631-100-30)
Marketing Start Date2009-04-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10631-100-30 [10631010030]

Exelderm SOLUTION
Marketing CategoryNDA
Application NumberNDA018738
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-04-08

NDC 10631-100-04 [10631010004]

Exelderm SOLUTION
Marketing CategoryNDA
Application NumberNDA018738
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-04-08

NDC 10631-100-32 [10631010032]

Exelderm SOLUTION
Marketing CategoryNDA
Application NumberNDA018738
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-04-08
Marketing End Date2012-05-05

Drug Details

Active Ingredients

IngredientStrength
SULCONAZOLE NITRATE10 mg/mL

OpenFDA Data

SPL SET ID:b3aea089-3961-43ea-8335-8128e9bae13b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 208118
  • 313125
  • UPC Code
  • 0310631100308
  • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]
    • Azole Antifungal [EPC]
    • Azoles [CS]

    Medicade Reported Pricing

    10631010030 EXELDERM 1% SOLUTION

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Exelderm" or generic name "Sulconazole Nitrate"

    NDCBrand NameGeneric Name
    10631-100Exeldermsulconazole nitrate
    10631-101Exeldermsulconazole nitrate
    69489-711ExeldermSulconazole Nitrate
    69489-721ExeldermSulconazole Nitrate
    72143-311Sulconazole NitrateSulconazole Nitrate
    72143-321Sulconazole NitrateSulconazole Nitrate

    Trademark Results [Exelderm]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EXELDERM
    EXELDERM
    73304315 1206693 Live/Registered
    Syntex (U.S.A.) Inc.
    1981-04-06

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