Dapsone
- Product NDC
- 69238-1627
- 11-digit product format
- 692381627
- Labeler code
- 69238
- Product ID
- 69238-1627_0622cdcc-1196-4a2f-8c85-6f34f0f97f9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Daspone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA212701
- Marketing category
- ANDA
- Marketing start
- 2023-06-02
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1627-6 | Dapsone | 60 g in 1 BOTTLE, PUMP | GEL | 60 | | 7 |
| 69238-1627-6 | Dapsone | 1 in 1 CARTON | GEL | 1 | | 7 |
| 69238-1627-9 | Dapsone | 90 g in 1 BOTTLE, PUMP | GEL | 90 | | 7 |
| 69238-1627-9 | Dapsone | 1 in 1 CARTON | GEL | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1627 | DAPSONE (DASPONE) GEL [AMNEAL PHARMACEUTICALS NY LLC] | 7 | Current NDC, 4 package rows | 20230602_fba0b181-077a-4667-bde1-cf9592f120c2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69238-1627-6 | 69238162706 | 1 BOTTLE, PUMP in 1 CARTON (69238-1627-6) / 60 g in 1 BOTTLE, PUMP | 2023-06-02 | No | No | Historical |
| 69238-1627-9 | 69238162709 | 1 BOTTLE, PUMP in 1 CARTON (69238-1627-9) / 90 g in 1 BOTTLE, PUMP | 2023-06-02 | No | No | Historical |