Otezla
- Product NDC
- 55513-519
- 11-digit product format
- 555130519
- Labeler code
- 55513
- Product ID
- 55513-519_8d1d49ca-6dc1-4580-b2d5-f69ccb4f1c8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- apremilast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amgen, Inc
- Application
- NDA210745
- Marketing category
- NDA
- Marketing start
- 2025-08-29
- Substance
- APREMILAST
- Active strength
- 75 mg/1
- Pharmacologic classes
- Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
- 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 |
|---|---|---|---|---|---|---|---|
| N210745-001 | OTEZLA XR | APREMILAST | 75MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-08-29 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N210745-001 | 7427638 | 2028-02-16 | Drug substance, Drug product | 2025-09-24 | |
| N210745-001 | 10092541 | 2034-05-29 | U-2659 | 2025-09-24 | |
| N210745-001 | 11752129 | 2042-05-27 | U-4264 | Drug product | 2025-09-24 |
| N210745-001 | 11752129 | 2042-05-27 | U-4265 | Drug product | 2025-09-24 |
| N210745-001 | 11752129 | 2042-05-27 | U-4266 | Drug product | 2025-09-24 |
| N210745-001 | 11969409 | 2042-05-27 | Drug product | 2025-09-24 | |
| N210745-001 | 12427136 | 2042-05-27 | U-1858 | 2025-10-28 | |
| N210745-001 | 12427136 | 2042-05-27 | U-4290 | 2025-10-28 | |
| N210745-001 | 12427136 | 2042-05-27 | U-4291 | 2025-10-28 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N210745-001 | ODE* | 2026-07-19 |
| N210745-001 | M-299 | 2026-07-20 |
| N210745-001 | PED | 2027-01-19 |
| N210745-001 | PED | 2027-01-20 |
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 | N210745-001 | OTEZLA XR | 75MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-08-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | OTEZLA XR | 75MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-08-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | OTEZLA XR | 75MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-08-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | OTEZLA XR | 75MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-08-29 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210745-001 | OTEZLA XR | 75MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-08-29 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | 7427638 | 2028-02-16 | Drug substance, Drug product | 2025-09-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | 10092541 | 2034-05-29 | U-2659 | 2025-09-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | 11752129 | 2042-05-27 | U-4264 | Drug product | 2025-09-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | 11752129 | 2042-05-27 | U-4265 | Drug product | 2025-09-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | 11752129 | 2042-05-27 | U-4266 | Drug product | 2025-09-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | 11969409 | 2042-05-27 | Drug product | 2025-09-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | 12427136 | 2042-05-27 | U-1858 | 2025-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | 12427136 | 2042-05-27 | U-4290 | 2025-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | 12427136 | 2042-05-27 | U-4291 | 2025-10-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | 7427638 | 2028-02-16 | Drug substance, Drug product | 2025-09-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | 10092541 | 2034-05-29 | U-2659 | 2025-09-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | 11752129 | 2042-05-27 | U-4264 | Drug product | 2025-09-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | 11752129 | 2042-05-27 | U-4265 | Drug product | 2025-09-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | 11752129 | 2042-05-27 | U-4266 | Drug product | 2025-09-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | 11969409 | 2042-05-27 | Drug product | 2025-09-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | 12427136 | 2042-05-27 | U-1858 | 2025-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | 12427136 | 2042-05-27 | U-4290 | 2025-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | 12427136 | 2042-05-27 | U-4291 | 2025-10-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | 7427638 | 2028-02-16 | Drug substance, Drug product | 2025-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | 10092541 | 2034-05-29 | U-2659 | 2025-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | 11752129 | 2042-05-27 | U-4264 | Drug product | 2025-09-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | 11752129 | 2042-05-27 | U-4265 | Drug product | 2025-09-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | 11752129 | 2042-05-27 | U-4266 | Drug product | 2025-09-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | 11969409 | 2042-05-27 | Drug product | 2025-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | 12427136 | 2042-05-27 | U-1858 | 2025-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | 12427136 | 2042-05-27 | U-4290 | 2025-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | 12427136 | 2042-05-27 | U-4291 | 2025-10-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | 7427638 | 2028-02-16 | Drug substance, Drug product | 2025-09-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | 10092541 | 2034-05-29 | U-2659 | 2025-09-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | 11752129 | 2042-05-27 | U-4264 | Drug product | 2025-09-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | 11752129 | 2042-05-27 | U-4265 | Drug product | 2025-09-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | 11752129 | 2042-05-27 | U-4266 | Drug product | 2025-09-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | 11969409 | 2042-05-27 | Drug product | 2025-09-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | 12427136 | 2042-05-27 | U-1858 | 2025-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | 12427136 | 2042-05-27 | U-4290 | 2025-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | 12427136 | 2042-05-27 | U-4291 | 2025-10-28 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210745-001 | 7427638 | 2028-02-16 | Drug substance, Drug product | 2025-09-24 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210745-001 | 10092541 | 2034-05-29 | U-2659 | 2025-09-24 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210745-001 | 11752129 | 2042-05-27 | U-4264 | Drug product | 2025-09-24 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210745-001 | 11752129 | 2042-05-27 | U-4265 | Drug product | 2025-09-24 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | ODE* | 2026-07-19 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | M-299 | 2026-07-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | PED | 2027-01-19 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210745-001 | PED | 2027-01-20 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | ODE* | 2026-07-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | M-299 | 2026-07-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | PED | 2027-01-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N210745-001 | PED | 2027-01-20 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | ODE* | 2026-07-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | M-299 | 2026-07-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | PED | 2027-01-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N210745-001 | PED | 2027-01-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | ODE* | 2026-07-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | M-299 | 2026-07-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | PED | 2027-01-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210745-001 | PED | 2027-01-20 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210745-001 | ODE* | 2026-07-19 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210745-001 | M-299 | 2026-07-20 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210745-001 | PED | 2027-01-19 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210745-001 | PED | 2027-01-20 | 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
- Otezla
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| APREMILAST | 75 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| UP7QBP99PN | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1492732 | Internal RxNorm lookup |
| 1492738 | Internal RxNorm lookup |
| 1492740 | Internal RxNorm lookup |
| 1492742 | Internal RxNorm lookup |
| 1492744 | Internal RxNorm lookup |
| 1492746 | Internal RxNorm lookup |
| 1492747 | Internal RxNorm lookup |
| 1492748 | Internal RxNorm lookup |
| 1605454 | Internal RxNorm lookup |
| 1605455 | Internal RxNorm lookup |
| 2682429 | Internal RxNorm lookup |
| 2682430 | Internal RxNorm lookup |
| 2682431 | Internal RxNorm lookup |
| 2682432 | Internal RxNorm lookup |
| 2723448 | Internal RxNorm lookup |
| 2723452 | Internal RxNorm lookup |
| 2724366 | Internal RxNorm lookup |
| 2724367 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f6b1f516-4972-4d82-bced-113e47b41cc5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 60f3bca3-f66c-4779-8fd1-16dc6df0a73e | Product name | 6 | 20250818 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55513-519-30 | Otezla | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 34 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55513-519-30 | EA - Each | 55513-519 | d2e91a96-9f51-445b-b9e8-e86dc070e43e | 1 | 2025-10-14 |
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 |
|---|---|---|---|---|---|---|
| Otezla | APREMILAST | Amgen, Inc | f6b1f516-4972-4d82-bced-113e47b41cc5 | 2026-09-02 | Warnings, Adverse reactions | 210745 NDA210745 55513-519 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2724367 | {14 (24 HR apremilast 75 MG Extended Release Oral Tablet [Otezla]) / 4 (apremilast 10 MG Oral Tablet [Otezla]) / 4 (apremilast 20 MG Oral Tablet [Otezla]) / 19 (apremilast 30 MG Oral Tablet [Otezla]) } Pack [Otezla 28-Day 10/20/30/75 Starter Pack] | BPCK | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2682432 | {4 (apremilast 10 MG Oral Tablet [Otezla]) / 23 (apremilast 20 MG Oral Tablet [Otezla]) } Pack [Otezla 14-Day 10/20 Starter Pack] | BPCK | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492748 | {4 (apremilast 10 MG Oral Tablet [Otezla]) / 4 (apremilast 20 MG Oral Tablet [Otezla]) / 19 (apremilast 30 MG Oral Tablet [Otezla]) } Pack [Otezla 14-Day 10/20/30 Starter Pack] | BPCK | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1605455 | {4 (apremilast 10 MG Oral Tablet [Otezla]) / 4 (apremilast 20 MG Oral Tablet [Otezla]) / 47 (apremilast 30 MG Oral Tablet [Otezla]) } Pack [Otezla 28-Day 10/20/30 Starter Pack] | BPCK | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2682430 | {4 (apremilast 10 MG Oral Tablet [Otezla]) / 51 (apremilast 20 MG Oral Tablet [Otezla]) } Pack [Otezla 28-Day 10/20 Starter Pack] | BPCK | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2724366 | {14 (24 HR apremilast 75 MG Extended Release Oral Tablet) / 4 (apremilast 10 MG Oral Tablet) / 4 (apremilast 20 MG Oral Tablet) / 19 (apremilast 30 MG Oral Tablet) } Pack | GPCK | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2682431 | {4 (apremilast 10 MG Oral Tablet) / 23 (apremilast 20 MG Oral Tablet) } Pack | GPCK | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492747 | {4 (apremilast 10 MG Oral Tablet) / 4 (apremilast 20 MG Oral Tablet) / 19 (apremilast 30 MG Oral Tablet) } Pack | GPCK | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1605454 | {4 (apremilast 10 MG Oral Tablet) / 4 (apremilast 20 MG Oral Tablet) / 47 (apremilast 30 MG Oral Tablet) } Pack | GPCK | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2682429 | {4 (apremilast 10 MG Oral Tablet) / 51 (apremilast 20 MG Oral Tablet) } Pack | GPCK | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492732 | apremilast 10 MG Oral Tablet | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492740 | apremilast 20 MG Oral Tablet | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492744 | apremilast 30 MG Oral Tablet | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2723448 | apremilast 75 MG 24HR Extended Release Oral Tablet | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2682431 | apremilast starter pack 10 MG (4), 20 MG (23) Oral Tablet 14-Day Pack | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492747 | apremilast starter pack 10 MG (4), 20 MG (4), 30 MG (19) Oral Tablet 14-Day Pack | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2724366 | apremilast starter pack 10 MG (4), 20 MG (4), 30 MG (19), 75 MG XR (14) Oral Tablet 28-Day Pack | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1605454 | apremilast starter pack 10 MG (4), 20 MG (4), 30 MG (47) Oral Tablet 28-Day Pack | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2682429 | apremilast starter pack 10 MG (4), 20 MG (51) Oral Tablet 28-Day Pack | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492738 | Otezla 10 MG Oral Tablet | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2682432 | Otezla 14-Day 10/20 Starter Pack | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492748 | Otezla 14-Day 10/20/30 Starter Pack | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492742 | Otezla 20 MG Oral Tablet | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2682430 | Otezla 28-Day 10/20 Starter Pack | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1605455 | Otezla 28-Day 10/20/30 Starter Pack | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2724367 | Otezla 28-Day 10/20/30/75 Starter Pack | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492746 | Otezla 30 MG Oral Tablet | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2723452 | Otezla XR 75 MG 24HR Extended Release Oral Tablet | PSN | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2723452 | 24 HR apremilast 75 MG Extended Release Oral Tablet [Otezla] | SBD | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492738 | apremilast 10 MG Oral Tablet [Otezla] | SBD | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492742 | apremilast 20 MG Oral Tablet [Otezla] | SBD | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492746 | apremilast 30 MG Oral Tablet [Otezla] | SBD | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2723448 | 24 HR apremilast 75 MG Extended Release Oral Tablet | SCD | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492732 | apremilast 10 MG Oral Tablet | SCD | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492740 | apremilast 20 MG Oral Tablet | SCD | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492744 | apremilast 30 MG Oral Tablet | SCD | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2682431 | apremilast 14-day 10/20 starter pack | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492747 | apremilast 14-day 10/20/30 starter pack | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2682429 | apremilast 28-day 10/20 starter pack | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1605454 | apremilast 28-day 10/20/30 starter pack | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2723448 | apremilast 75 MG 24HR Extended Release Oral Tablet | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2724366 | apremilast starter pack 10 MG (4), 20 MG (4), 30 MG (19), 75 MG XR (14) Oral Tablet 28-Day Pack | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492738 | Otezla 10 MG Oral Tablet | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2682432 | Otezla 14-Day 10/20 Starter Pack | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492748 | Otezla 14-Day 10/20/30 Starter Pack | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492742 | Otezla 20 MG Oral Tablet | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2682430 | Otezla 28-Day 10/20 Starter Pack | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1605455 | Otezla 28-Day 10/20/30 Starter Pack | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2724367 | Otezla 28-Day 10/20/30/75 Starter Pack | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 1492746 | Otezla 30 MG Oral Tablet | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
| 2723452 | Otezla XR 75 MG 24HR Extended Release Oral Tablet | SY | f6b1f516-4972-4d82-bced-113e47b41cc5 | 34 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 55513-519-30 | 55513051930 | 30 TABLET, FILM COATED in 1 BOTTLE (55513-519-30) | 2025-08-31 | No | No | Current |