Dapsone
- Product NDC
- 51672-1388
- 11-digit product format
- 516721388
- Labeler code
- 51672
- Product ID
- 51672-1388_38efc7a1-c4c6-61ad-e063-6294a90af18b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapsone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA210191
- Marketing category
- ANDA
- Marketing start
- 2019-06-26
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-1388 | DAPSONE GEL [TARO PHARMACEUTICALS U.S.A., INC.] | 8 | Current NDC, Legacy NDC, 6 package rows | 20250112_32fcb7e0-5a6d-4d95-b81c-148012a54112.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 |
|---|
| 51672-1388-2 | 51672138802 | 1 BOTTLE, PUMP in 1 CARTON (51672-1388-2) / 30 g in 1 BOTTLE, PUMP | 2019-06-26 | 0000-00-00 | No | No | Current |
| 51672-1388-3 | 51672138803 | 1 BOTTLE, PUMP in 1 CARTON (51672-1388-3) / 60 g in 1 BOTTLE, PUMP | 2019-06-26 | 0000-00-00 | No | No | Current |
| 51672-1388-8 | 51672138808 | 1 BOTTLE, PUMP in 1 CARTON (51672-1388-8) / 90 g in 1 BOTTLE, PUMP | 2019-06-26 | 0000-00-00 | No | No | Current |