Dapsone
- Product NDC
- 70771-1538
- 11-digit product format
- 707711538
- Labeler code
- 70771
- Product ID
- 70771-1538_ae448df2-611f-4d56-911f-11d01983726f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapsone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA214019
- Marketing category
- ANDA
- Marketing start
- 2024-05-10
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1538 | DAPSONE GEL [ZYDUS LIFESCIENCES LIMITED] | 1 | Current NDC, 6 package rows | 20240511_8b63b653-0507-4f95-9bfa-70fd071e15a6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1538-2 | 70771153802 | 1 BOTTLE, PUMP in 1 CARTON (70771-1538-2) / 30 g in 1 BOTTLE, PUMP | 2024-05-10 | No | No | Current |
| 70771-1538-3 | 70771153803 | 1 BOTTLE, PUMP in 1 CARTON (70771-1538-3) / 60 g in 1 BOTTLE, PUMP | 2024-05-10 | No | No | Current |
| 70771-1538-8 | 70771153808 | 1 BOTTLE, PUMP in 1 CARTON (70771-1538-8) / 90 g in 1 BOTTLE, PUMP | 2024-05-10 | No | No | Current |