dapsone
- Product NDC
- 13668-605
- 11-digit product format
- 136680605
- Labeler code
- 13668
- Product ID
- 13668-605_2c733874-9036-42d0-8820-d5a4a35b5adc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dapsone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA214722
- Marketing category
- ANDA
- Marketing start
- 2022-02-10
- 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 |
|---|
| 13668-605-05 | dapsone | 1 in 1 CARTON | GEL | 1 | | 7 |
| 13668-605-05 | dapsone | 60 g in 1 BOTTLE, PUMP | GEL | 60 | | 7 |
| 13668-605-08 | dapsone | 1 in 1 CARTON | GEL | 1 | | 7 |
| 13668-605-08 | dapsone | 90 g in 1 BOTTLE, PUMP | GEL | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-605 | DAPSONE GEL [TORRENT PHARMACEUTICALS LIMITED] | 6 | Current NDC, Legacy NDC, 4 package rows | 20241105_f8cffc24-8310-4f21-ae77-7f6ad6095551.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 |
|---|
| 13668-605-05 | 13668060505 | 1 BOTTLE, PUMP in 1 CARTON (13668-605-05) / 60 g in 1 BOTTLE, PUMP | 2022-02-10 | 0000-00-00 | No | No | Current |
| 13668-605-08 | 13668060508 | 1 BOTTLE, PUMP in 1 CARTON (13668-605-08) / 90 g in 1 BOTTLE, PUMP | 2022-02-10 | 0000-00-00 | No | No | Current |