Dapsone
- Product NDC
- 65162-339
- 11-digit product format
- 651620339
- Labeler code
- 65162
- Product ID
- 65162-339_e09d2bfe-ca6f-4f12-ba61-993371b94478
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapsone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA209890
- Marketing category
- ANDA
- Marketing start
- 2023-10-24
- 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 |
|---|
| 65162-339 | DAPSONE GEL [AMNEAL PHARMACEUTICALS LLC] | 7 | Current NDC, 6 package rows | 20241027_f3e33970-ac11-4bb6-9f39-6f58d86fdefb.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 |
|---|
| 65162-339-63 | 65162033963 | 1 TUBE in 1 CARTON (65162-339-63) / 30 g in 1 TUBE | 1 tube | 2023-10-24 | No | No | Current |
| 65162-339-85 | 65162033985 | 1 TUBE in 1 CARTON (65162-339-85) / 60 g in 1 TUBE | 1 tube | 2023-10-24 | No | No | Current |
| 65162-339-91 | 65162033991 | 1 TUBE in 1 CARTON (65162-339-91) / 90 g in 1 TUBE | 1 tube | 2023-10-24 | No | No | Current |