Dapsone
- Product NDC
- 52817-831
- 11-digit product format
- 528170831
- Labeler code
- 52817
- Product ID
- 52817-831_3e0f42a7-3013-cad1-e063-6394a90a7dfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapsone Gel, 5%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Trupharma, LLC
- Application
- ANDA213907
- Marketing category
- ANDA
- Marketing start
- 2024-03-01
- 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 |
|---|
| 52817-831 | DAPSONE (DAPSONE GEL, 5%) GEL [TRUPHARMA, LLC] | 2 | Current NDC, 4 package rows | 20241123_699b6157-3245-43b6-91ee-c86ea262bc83.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 |
|---|
| 52817-831-60 | 52817083160 | 1 TUBE in 1 CARTON (52817-831-60) / 60 g in 1 TUBE | 1 tube | 2024-03-01 | No | No | Current |
| 52817-831-90 | 52817083190 | 1 TUBE in 1 CARTON (52817-831-90) / 90 g in 1 TUBE | 1 tube | 2024-03-01 | No | No | Current |