Dapsone
- Product NDC
- 0378-4830
- 11-digit product format
- 003784830
- Labeler code
- 0378
- Product ID
- 0378-4830_9feeeb14-77f7-47c7-816f-515ea0a60463
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapsone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA213847
- Marketing category
- ANDA
- Marketing start
- 2022-05-20
- 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 |
|---|
| 0378-4830-60 | Dapsone | 60 g in 1 BOTTLE, PUMP | GEL | 60 | | 2 |
| 0378-4830-60 | Dapsone | 1 in 1 CARTON | GEL | 1 | | 2 |
| 0378-4830-90 | Dapsone | 90 g in 1 BOTTLE, PUMP | GEL | 90 | | 2 |
| 0378-4830-90 | Dapsone | 1 in 1 CARTON | GEL | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-4830 | DAPSONE GEL [MYLAN PHARMACEUTICALS INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20240731_e04da0a1-d02a-487d-a931-a31034738fdd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-4830-60 | 00378483060 | 1 BOTTLE, PUMP in 1 CARTON (0378-4830-60) / 60 g in 1 BOTTLE, PUMP | 2022-05-20 | 0000-00-00 | No | No | Current |
| 0378-4830-90 | 00378483090 | 1 BOTTLE, PUMP in 1 CARTON (0378-4830-90) / 90 g in 1 BOTTLE, PUMP | 2022-05-20 | 0000-00-00 | No | No | Current |