Otezla
- Product NDC
- 55513-508
- 11-digit product format
- 555130508
- Labeler code
- 55513
- Product ID
- 55513-508_d869faaf-a5ad-4b12-b427-06587d17787e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- apremilast
- Dosage form
- KIT
- Labeler
- Amgen, Inc
- Application
- NDA205437
- Marketing category
- NDA
- Marketing start
- 2024-04-25
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| UP7QBP99PN | APREMILAST | 608141-41-9 | apremilast |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55513-508-55 | 55513050855 | 1 KIT in 1 BLISTER PACK (55513-508-55) * 51 TABLET, FILM COATED in 1 BLISTER PACK (55513-497-51) * 4 TABLET, FILM COATED in 1 BLISTER PACK (55513-518-04) | 1 kit | 2024-04-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Otezla | Amgen, Inc | Celgene International Sarl | 2025-12-23 | HUMAN PRESCRIPTION DRUG LABEL | 34 |