Exelderm
- Product NDC
- 69489-721
- 11-digit product format
- 694890721
- Labeler code
- 69489
- Product ID
- 69489-721_af026933-9a3d-4027-90f6-57fe4349d11e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulconazole Nitrate
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Journey Medical Corporation
- Application
- NDA018738
- Marketing category
- NDA
- Marketing start
- 2019-06-07
- Marketing end
- 2027-10-31
- Substance
- SULCONAZOLE NITRATE
- Active strength
- 10 mg/mL
- 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
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SULCONAZOLE NITRATE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1T89100D5U |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69489-721-05 | Exelderm | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 3 |
| 69489-721-30 | Exelderm | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 69489-721-30 | Exelderm | 30 mL in 1 BOTTLE | SOLUTION | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69489-721 | EXELDERM (SULCONAZOLE NITRATE) SOLUTION [JOURNEY MEDICAL CORPORATION] | 3 | Current NDC, Legacy NDC, 3 package rows | 20221110_5b73e83e-8d3c-4d96-b4f6-9f854430add8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69489-721-05 | 69489072105 | 5 mL in 1 BOTTLE (69489-721-05) | 5 ml | 2021-03-15 | 0000-00-00 | Yes | No | Current |
| 69489-721-30 | 69489072130 | 1 BOTTLE in 1 CARTON (69489-721-30) / 30 mL in 1 BOTTLE | 1 bottle | 2019-06-07 | 0000-00-00 | No | No | Current |