DAPSONE
- Product NDC
- 70954-136
- 11-digit product format
- 709540136
- Labeler code
- 70954
- Product ID
- 70954-136_846ff8b6-d395-4e67-98ea-9dbfd688b97e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapsone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA206505
- Marketing category
- ANDA
- Marketing start
- 2018-01-15
- Substance
- DAPSONE
- Active strength
- 100 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 | 100 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 |
|---|
| 70954-136-10 | DAPSONE | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 70954-136-20 | DAPSONE | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-136 | DAPSONE TABLET [ANI PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250429_57a47368-d1f6-4d61-a2ee-c5f1fe7ff690.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70954-136-10 | 70954013610 | 30 TABLET in 1 BOTTLE (70954-136-10) | 30 tablet | 2018-01-15 | 0000-00-00 | No | No | Current |
| 70954-136-20 | 70954013620 | 100 TABLET in 1 BOTTLE (70954-136-20) | 100 tablet | 2018-01-15 | 0000-00-00 | No | No | Current |