ACZONE
- Product NDC
- 16110-367
- 11-digit product format
- 161100367
- Labeler code
- 16110
- Product ID
- 16110-367_4b6c672f-a7c3-4123-8f64-c08b3d7ae906
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dapsone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- ALMIRALL, LLC
- Application
- NDA021794
- Marketing category
- NDA
- Marketing start
- 2022-02-12
- Marketing end
- 0000-00-00
- Substance
- DAPSONE
- Active strength
- 50 mg/g
- Pharmacologic classes
- Sulfone [EPC], Sulfones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 16110-367-60 | 2022-03-29 | C162847 | 48780-1 | d6a99b3a-00a4-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use ACZONE ® Gel, 5% safely and effectively. See full prescribing information for ACZONE ® Gel, 5% . ACZONE ® (dapsone) Gel, 5%, for topical use Initial U.S. Approval: 1955 |
| 16110-367-90 | 2022-03-29 | C162847 | 48780-1 | d6a99b3a-00a4-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use ACZONE ® Gel, 5% safely and effectively. See full prescribing information for ACZONE ® Gel, 5% . ACZONE ® (dapsone) Gel, 5%, for topical use Initial U.S. Approval: 1955 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16110-367 | ACZONE (DAPSONE) GEL [ALMIRALL, LLC] | 7 | Legacy NDC | 20240906_fc4ac90b-8962-4b9b-8c69-b1ea59d00009.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16110-367-60 | 16110036760 | 1 TUBE in 1 CARTON (16110-367-60) > 60 g in 1 TUBE | 1 tube | 2022-02-12 | 0000-00-00 | No | No | Current |
| 16110-367-90 | 16110036790 | 1 TUBE in 1 CARTON (16110-367-90) > 90 g in 1 TUBE | 1 tube | 2022-02-12 | 0000-00-00 | No | No | Current |