Dapsone
- Product NDC
- 51672-5307
- 11-digit product format
- 516725307
- Labeler code
- 51672
- Product ID
- 51672-5307_2ba804da-6201-4803-b508-2397da080f32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapsone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Taro Pharmaceuticals U.S.A., Inc.
- Application
- NDA207154
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-01-01
- Marketing end
- 0000-00-00
- Substance
- DAPSONE
- Active strength
- 75 mg/g
- Pharmacologic classes
- Sulfone [EPC],Sulfones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 51672-5307-3 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-af4b-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use Dapsone Gel, 7.5% safely and effectively. See full prescribing information for Dapsone Gel, 7.5%. Dapsone Gel, 7.5%, for topical use Initial U.S. Approval: 1955 |
| 51672-5307-8 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-af4b-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use Dapsone Gel, 7.5% safely and effectively. See full prescribing information for Dapsone Gel, 7.5%. Dapsone Gel, 7.5%, for topical use Initial U.S. Approval: 1955 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-5307-3 | Dapsone | 60 g in 1 BOTTLE, PUMP | GEL | 60 | | 3 |
| 51672-5307-3 | Dapsone | 1 in 1 CARTON | GEL | 1 | | 3 |
| 51672-5307-8 | Dapsone | 90 g in 1 BOTTLE, PUMP | GEL | 90 | | 3 |
| 51672-5307-8 | Dapsone | 1 in 1 CARTON | GEL | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-5307 | DAPSONE GEL [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | Legacy NDC, 4 package rows | 20210511_ec99b115-d163-4145-8c76-cb1a008305a4.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 |
|---|
| 51672-5307-3 | 51672530703 | 1 BOTTLE, PUMP in 1 CARTON (51672-5307-3) > 60 g in 1 BOTTLE, PUMP | 2020-01-01 | 0000-00-00 | No | No | Current |
| 51672-5307-8 | 51672530708 | 1 BOTTLE, PUMP in 1 CARTON (51672-5307-8) > 90 g in 1 BOTTLE, PUMP | 2020-01-01 | 0000-00-00 | No | No | Current |