NDC 69489-721

Exelderm

Sulconazole Nitrate

Exelderm is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Journey Medical Corporation. The primary component is Sulconazole Nitrate.

Product ID69489-721_369a143e-22bb-4b50-82fe-1862daeed6c9
NDC69489-721
Product TypeHuman Prescription Drug
Proprietary NameExelderm
Generic NameSulconazole Nitrate
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2019-06-07
Marketing CategoryNDA / NDA
Application NumberNDA018738
Labeler NameJourney Medical Corporation
Substance NameSULCONAZOLE NITRATE
Active Ingredient Strength10 mg/mL
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69489-721-30

1 BOTTLE in 1 CARTON (69489-721-30) > 30 mL in 1 BOTTLE
Marketing Start Date2019-06-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69489-721-30 [69489072130]

Exelderm SOLUTION
Marketing CategoryNDA
Application NumberNDA018738
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-07

Drug Details

Active Ingredients

IngredientStrength
SULCONAZOLE NITRATE10 mg/mL

Pharmacological Class

  • Azole Antifungal [EPC]
  • Azoles [CS]

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

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