Dapsone
- Product NDC
- 69367-378
- 11-digit product format
- 693670378
- Labeler code
- 69367
- Product ID
- 69367-378_133a7b8c-5bf0-41f7-84e1-7dac278986d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapsone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA086841
- Marketing category
- ANDA
- Marketing start
- 2024-01-16
- Substance
- DAPSONE
- Active strength
- 25 mg/1
- 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8W5C518302 |
| Rxcui | 197557, 197558 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-378-01 | Dapsone | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 69367-378-30 | Dapsone | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-378 | DAPSONE TABLET [WESTMINSTER PHARMACEUTICALS, LLC] | 2 | Current NDC, 2 package rows | 20240202_d3fc4934-d48b-4a29-9022-0c82bbdad399.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 |
|---|
| 69367-378-01 | 69367037801 | 100 TABLET in 1 BOTTLE (69367-378-01) | 100 tablet | 2024-01-16 | No | No | Current |
| 69367-378-30 | 69367037830 | 30 TABLET in 1 BOTTLE (69367-378-30) | 30 tablet | 2024-01-16 | No | No | Current |