exelderm

Generic: sulconazole nitrate

Labeler: journey medical corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name exelderm
Generic Name sulconazole nitrate
Labeler journey medical corporation
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

sulconazole nitrate 10 mg/mL

Manufacturer
Journey Medical Corporation

Identifiers & Regulatory

Product NDC 69489-721
Product ID 69489-721_af026933-9a3d-4027-90f6-57fe4349d11e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018738
Listing Expiration 2026-12-31
Marketing Start 2019-06-07

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69489721
Hyphenated Format 69489-721

Supplemental Identifiers

RxCUI
208118 313125
UNII
1T89100D5U

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name exelderm (source: ndc)
Generic Name sulconazole nitrate (source: ndc)
Application Number NDA018738 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE (69489-721-05)
  • 1 BOTTLE in 1 CARTON (69489-721-30) / 30 mL in 1 BOTTLE
source: ndc

Packages (2)

69489-721-05 5 mL in 1 BOTTLE (69489-721-05) 69489-721-30 1 BOTTLE in 1 CARTON (69489-721-30) / 30 mL in 1 BOTTLE

Ingredients (1)

sulconazole nitrate (10 mg/mL)

Linked Drug Pages (1)

Exelderm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "af026933-9a3d-4027-90f6-57fe4349d11e", "openfda": {"unii": ["1T89100D5U"], "rxcui": ["208118", "313125"], "spl_set_id": ["5b73e83e-8d3c-4d96-b4f6-9f854430add8"], "manufacturer_name": ["Journey Medical Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "5 mL in 1 BOTTLE (69489-721-05)", "package_ndc": "69489-721-05", "marketing_start_date": "20210315"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69489-721-30)  / 30 mL in 1 BOTTLE", "package_ndc": "69489-721-30", "marketing_start_date": "20190607"}], "brand_name": "Exelderm", "product_id": "69489-721_af026933-9a3d-4027-90f6-57fe4349d11e", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "69489-721", "generic_name": "Sulconazole Nitrate", "labeler_name": "Journey Medical Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Exelderm", "active_ingredients": [{"name": "SULCONAZOLE NITRATE", "strength": "10 mg/mL"}], "application_number": "NDA018738", "marketing_category": "NDA", "marketing_start_date": "20190607", "listing_expiration_date": "20261231"}