Aczone
- Product NDC
- 16110-526
- 11-digit product format
- 161100526
- Labeler code
- 16110
- Product ID
- 16110-526_fee319ef-b2af-415e-8e91-32aaccc024da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dapsone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Almirall, LLC
- Application
- NDA207154
- Marketing category
- NDA
- Marketing start
- 2019-09-10
- 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
- Aczone
- 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, 1741907 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16110-526 | ACZONE (DAPSONE) GEL [ALMIRALL, LLC] | 6 | Current NDC, Legacy NDC, 6 package rows | 20240424_22058b7d-a578-4eaa-a476-ac982337f02a.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 |
|---|
| 16110-526-30 | 16110052630 | 1 BOTTLE, PUMP in 1 CARTON (16110-526-30) > 30 g in 1 BOTTLE, PUMP | 2019-09-10 | 0000-00-00 | No | No | Current |
| 16110-526-60 | 16110052660 | 1 BOTTLE, PUMP in 1 CARTON (16110-526-60) / 60 g in 1 BOTTLE, PUMP | 2019-09-10 | 0000-00-00 | No | No | Current |
| 16110-526-90 | 16110052690 | 1 BOTTLE, PUMP in 1 CARTON (16110-526-90) / 90 g in 1 BOTTLE, PUMP | 2019-09-10 | 0000-00-00 | No | No | Current |