DAPSONE
- Product NDC
- 62332-551
- Requested package NDC
- 62332-551-90
- 11-digit product format
- 623320551
- Labeler code
- 62332
- Product ID
- 62332-551_d9849120-ccaa-4820-8e8d-3a8c7d809ffb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DAPSONE
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA213414
- Marketing category
- ANDA
- Marketing start
- 2026-07-01
- Substance
- DAPSONE
- Active strength
- 50 mg/g
- Pharmacologic classes
- Sulfone [EPC], Sulfones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213414-001 | DAPSONE | DAPSONE | 5% | GEL / TOPICAL | AB | 2026-06-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213414-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213414-001 | DAPSONE | 5% | GEL / TOPICAL | AB | 2026-06-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A213414-001 | DAPSONE | 5% | GEL / TOPICAL | AB | 2026-06-25 | caaa826d4ba7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213414-001 | DAPSONE | 5% | GEL / TOPICAL | AB | 2026-06-25 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213414-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A213414-001 | AB | 1 | caaa826d4ba7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213414-001 | AB | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DAPSONE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DAPSONE | 50 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8W5C518302 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 607295 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7249f655-1d8e-482a-889a-1e7e1a19500c | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DAPSONE | DAPSONE | Alembic Pharmaceuticals Limited | 0f1301f6-884d-4fc7-a5b2-421b2375b985 | 2026-07-09 | Warnings, Adverse reactions | 213414 ANDA213414 |
| DAPSONE | DAPSONE | Alembic Pharmaceuticals Inc. | 7249f655-1d8e-482a-889a-1e7e1a19500c | 2026-07-09 | Warnings, Adverse reactions | 213414 ANDA213414 62332-551-90 62332-551 62332055190 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 62332-551-90 | 62332055190 | 1 TUBE in 1 CARTON (62332-551-90) / 90 g in 1 TUBE | 1 tube | 2026-07-01 | No | No | Current |