OTEZLA
- Product NDC
- 59572-630
- 11-digit product format
- 595720630
- Labeler code
- 59572
- Product ID
- 59572-630_4b03ba80-afc7-4904-8c87-ef84b8fd25ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- apremilast
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- Celgene Corporation
- Application
- NDA205437
- Marketing category
- NDA
- Marketing start
- 2014-03-25
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59572-630-27 | 2025-03-18 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-630-99 | 2025-03-18 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-630-27 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-630-99 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-630-27 | 2021-02-08 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-630-99 | 2021-02-08 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-630-27 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-630-99 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59572-630-27 | EA - Each | 59572-630 | 9b348a52-bfba-4151-aae9-a8ea6c49de56 | 1 | 2014-04-03 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59572-630-27 | 59572063027 | 1 KIT in 1 BLISTER PACK (59572-630-27) | 1 kit | 2014-03-25 | 0000-00-00 | No | No | Current |
| 59572-630-99 | 59572063099 | 1 KIT in 1 BLISTER PACK (59572-630-99) | 1 kit | 2014-03-25 | 0000-00-00 | No | No | Current |