Dapsone
- Product NDC
- 46708-663
- 11-digit product format
- 467080663
- Labeler code
- 46708
- Product ID
- 46708-663_f201a2ad-d969-428f-bb66-13401c124c0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapsone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA215718
- Marketing category
- ANDA
- Marketing start
- 2023-10-30
- Substance
- DAPSONE
- Active strength
- 75 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 | 75 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8W5C518302 |
| Rxcui | 1741905 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-663-30 | 46708066330 | 1 BOTTLE, PUMP in 1 CARTON (46708-663-30) / 30 g in 1 BOTTLE, PUMP | 2023-10-30 | No | No | Current |
| 46708-663-60 | 46708066360 | 1 BOTTLE, PUMP in 1 CARTON (46708-663-60) / 60 g in 1 BOTTLE, PUMP | 2023-10-30 | No | No | Current |
| 46708-663-90 | 46708066390 | 1 BOTTLE, PUMP in 1 CARTON (46708-663-90) / 90 g in 1 BOTTLE, PUMP | 2023-10-30 | No | No | Current |