DAPSONE
- Product NDC
- 0713-0886
- 11-digit product format
- 007130886
- Labeler code
- 0713
- Product ID
- 0713-0886_fb368415-d58a-0601-e053-6394a90a92af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dapsone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA210178
- Marketing category
- ANDA
- Marketing start
- 2023-05-08
- Substance
- DAPSONE
- Active strength
- 50 mg/g
- Pharmacologic classes
- Sulfone [EPC], Sulfones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DAPSONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DAPSONE | 50 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8W5C518302 |
| Rxcui | 607295 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0886 | DAPSONE GEL [COSETTE PHARMACEUTICALS, INC.] | 1 | Current NDC, 4 package rows | 20230510_bc035edf-50d0-47ba-9b60-fe394ab3c32f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0713-0886-18 | 00713088618 | 1 TUBE in 1 CARTON (0713-0886-18) / 90 g in 1 TUBE | 1 tube | 2023-05-08 | No | No | Current |
| 0713-0886-60 | 00713088660 | 1 TUBE in 1 CARTON (0713-0886-60) / 60 g in 1 TUBE | 1 tube | 2023-05-08 | No | No | Current |