Dapsone
- Product NDC
- 51862-123
- 11-digit product format
- 518620123
- Labeler code
- 51862
- Product ID
- 51862-123_45c41a7a-58d6-48fd-bfe3-f9bc9508c335
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapsone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Mayne Pharma
- Application
- ANDA212383
- Marketing category
- ANDA
- Marketing start
- 2024-02-14
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51862-123-60 | Dapsone | 60 g in 1 TUBE | GEL | 60 | | 1 |
| 51862-123-60 | Dapsone | 1 in 1 CARTON | GEL | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51862-123 | DAPSONE GEL [MAYNE PHARMA] | 1 | Current NDC, 2 package rows | 20240214_dc495e54-8917-42de-a9fa-1f961bd99d61.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 |
|---|
| 51862-123-60 | 51862012360 | 1 TUBE in 1 CARTON (51862-123-60) / 60 g in 1 TUBE | 1 tube | 2024-02-14 | No | No | Historical |