Dapsone
- Product NDC
- 21922-018
- 11-digit product format
- 219220018
- Labeler code
- 21922
- Product ID
- 21922-018_4805ec1d-1a52-438d-8601-2878f5f40e08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapsone Gel, 5%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA212383
- Marketing category
- ANDA
- Marketing start
- 2023-10-16
- 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 |
|---|
| 21922-018 | DAPSONE (DAPSONE GEL, 5%) GEL [ENCUBE ETHICALS PRIVATE LIMITED] | 3 | Current NDC, 4 package rows | 20241206_4205a1a9-c459-47bb-9538-1dd559ca71f1.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 |
|---|
| 21922-018-07 | 21922001807 | 1 TUBE in 1 CARTON (21922-018-07) / 60 g in 1 TUBE | 1 tube | 2023-10-16 | No | No | Current |
| 21922-018-08 | 21922001808 | 1 TUBE in 1 CARTON (21922-018-08) / 90 g in 1 TUBE | 1 tube | 2023-10-16 | No | No | Current |