Exelderm

Product NDC
69489-711
11-digit product format
694890711
Labeler code
69489
Product ID
69489-711_f03361cb-005c-4d0c-bc27-033484f02624
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Journey Medical Corporation
Application
NDA018737
Marketing category
NDA
Marketing start
2019-06-07
Substance
SULCONAZOLE NITRATE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Exelderm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULCONAZOLE NITRATE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1T89100D5U
Rxcui106366, 208117

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
312a1339-2d03-1da9-f090-a47730c5330aProduct name120140508
a4a028cc-e548-445b-8dc3-ebf42e7603dbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69489-711-60Exelderm60 g in 1 TUBECREAM602
69489-711-60Exelderm1 in 1 CARTONCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69489-711-60GM - Gram69489-711081ee014-79c7-4d9e-b30c-860049d2a17712020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69489-711EXELDERM (SULCONAZOLE NITRATE) CREAM [JOURNEY MEDICAL CORPORATION]2Current NDC, Legacy NDC, 2 package rows20220721_1d822e06-f37e-4984-8365-efd4c4451478.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208117Exelderm 1 % Topical CreamPSN1d822e06-f37e-4984-8365-efd4c44514782
106366sulconazole nitrate 1 % Topical CreamPSN1d822e06-f37e-4984-8365-efd4c44514782
208117sulconazole nitrate 10 MG/ML Topical Cream [Exelderm]SBD1d822e06-f37e-4984-8365-efd4c44514782
106366sulconazole nitrate 10 MG/ML Topical CreamSCD1d822e06-f37e-4984-8365-efd4c44514782
208117Exelderm 1 % Topical CreamSY1d822e06-f37e-4984-8365-efd4c44514782
208117Exelderm 10 MG/ML Topical CreamSY1d822e06-f37e-4984-8365-efd4c44514782
106366sulconazole nitrate 1 % Topical CreamSY1d822e06-f37e-4984-8365-efd4c44514782

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69489-711-60694890711601 TUBE in 1 CARTON (69489-711-60) / 60 g in 1 TUBE1 tube2019-06-070000-00-00NoNoCurrent