Dapsone
- Product NDC
- 64980-567
- 11-digit product format
- 649800567
- Labeler code
- 64980
- Product ID
- 64980-567_e1aaf1ed-de8a-4c31-85de-68d728c95e86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dapsone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA207165
- Marketing category
- ANDA
- Marketing start
- 2023-07-20
- Substance
- DAPSONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Sulfone [EPC], Sulfones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dapsone
- Listing expiration
- 2027-12-31
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 |
|---|
| 64980-567-01 | Dapsone | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 64980-567-03 | Dapsone | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-567 | DAPSONE TABLET [RISING PHARMA HOLDINGS, INC.] | 5 | Current NDC, 2 package rows | 20230831_e369b26d-219a-4e23-b8d4-f94048d36acd.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 |
|---|
| 64980-567-01 | 64980056701 | 100 TABLET in 1 BOTTLE (64980-567-01) | 100 tablet | 2023-07-20 | No | No | Current |
| 64980-567-03 | 64980056703 | 30 TABLET in 1 BOTTLE (64980-567-03) | 30 tablet | 2023-08-29 | No | No | Current |