OTEZLA
- Product NDC
- 59572-631
- 11-digit product format
- 595720631
- Labeler code
- 59572
- Product ID
- 59572-631_4b03ba80-afc7-4904-8c87-ef84b8fd25ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- apremilast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Celgene Corporation
- Application
- NDA205437
- Marketing category
- NDA
- Marketing start
- 2014-04-03
- Marketing end
- 0000-00-00
- Substance
- APREMILAST
- Active strength
- 30 mg/1
- Pharmacologic classes
- Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]
- 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 |
|---|---|---|---|---|---|
| 59572-631-06 | 2025-03-18 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-631-28 | 2025-03-18 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-631-06 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-631-28 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-631-06 | 2021-02-08 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-631-28 | 2021-02-08 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-631-06 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1329-a910-e053-dadaa90a0b85 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
| 59572-631-28 | 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 |
|---|---|---|---|---|---|
| 59572-631-06 | EA - Each | 59572-631 | 93a0539b-e565-4f9f-8938-fbec979abbfd | 1 | 2014-05-02 |
| 59572-631-28 | EA - Each | 59572-631 | 4bdd5f00-f90a-4977-b264-4c3b9ea92ae9 | 1 | 2014-11-05 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59572-631-06 | 59572063106 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59572-631-06) | 2015-09-18 | 0000-00-00 | No | No | Current | |
| 59572-631-28 | 59572063128 | 28 BLISTER PACK in 1 CARTON (59572-631-28) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 28 blister pack | 2015-08-05 | 0000-00-00 | No | No | Current |