Home NDC 59572-631-06 OTEZLA
Product NDC 59572-631
Requested package NDC 59572-631-06
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205437-001 OTEZLA APREMILAST 10MG TABLET / ORAL AB RLD 2014-03-21 N205437-002 OTEZLA APREMILAST 20MG TABLET / ORAL AB RLD 2014-03-21 N205437-003 OTEZLA APREMILAST 30MG TABLET / ORAL AB RLD, RS 2014-03-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 36 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205437-001 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 N205437-001 7427638*PED 2028-08-16 Pediatric extension N205437-001 12576034 2033-11-30 U-1858 Drug product 2026-04-16 N205437-001 12576034 2033-11-30 U-4290 Drug product 2026-04-16 N205437-001 12576034 2033-11-30 U-4291 Drug product 2026-04-16 N205437-001 10092541 2034-05-29 U-2403 2018-10-09 N205437-001 10092541 2034-05-29 U-2659 2018-10-09 N205437-001 9872854 2034-05-29 U-2232 2018-02-21 N205437-001 9872854 2034-05-29 U-2233 2018-02-21 N205437-001 12576034*PED 2034-05-30 Pediatric extension N205437-001 10092541*PED 2034-11-29 Pediatric extension N205437-001 9872854*PED 2034-11-29 Pediatric extension N205437-002 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 N205437-002 7427638*PED 2028-08-16 Pediatric extension N205437-002 12576034 2033-11-30 U-1858 Drug product 2026-04-16 N205437-002 12576034 2033-11-30 U-4290 Drug product 2026-04-16 N205437-002 12576034 2033-11-30 U-4291 Drug product 2026-04-16 N205437-002 10092541 2034-05-29 U-2403 2018-10-09 N205437-002 10092541 2034-05-29 U-2659 2018-10-09 N205437-002 9872854 2034-05-29 U-2232 2018-02-21 N205437-002 9872854 2034-05-29 U-2233 2018-02-21 N205437-002 12576034*PED 2034-05-30 Pediatric extension N205437-002 10092541*PED 2034-11-29 Pediatric extension N205437-002 9872854*PED 2034-11-29 Pediatric extension N205437-003 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 N205437-003 7427638*PED 2028-08-16 Pediatric extension N205437-003 12576034 2033-11-30 U-1858 Drug product 2026-04-16 N205437-003 12576034 2033-11-30 U-4290 Drug product 2026-04-16 N205437-003 12576034 2033-11-30 U-4291 Drug product 2026-04-16 N205437-003 10092541 2034-05-29 U-2403 2018-10-09 N205437-003 10092541 2034-05-29 U-2659 2018-10-09 N205437-003 9872854 2034-05-29 U-2232 2018-02-21 N205437-003 9872854 2034-05-29 U-2233 2018-02-21 N205437-003 12576034*PED 2034-05-30 Pediatric extension N205437-003 10092541*PED 2034-11-29 Pediatric extension N205437-003 9872854*PED 2034-11-29 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 18 matching rows.
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.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 102 observed states.
Observed Orange Book patent history# Patent history page 1 of 61 · 2,436 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N205437-001 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 7427638*PED 2028-08-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 10092541 2034-05-29 U-2403 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 10092541 2034-05-29 U-2659 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 9872854 2034-05-29 U-2232 2018-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 9872854 2034-05-29 U-2233 2018-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 10092541*PED 2034-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 9872854*PED 2034-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 7427638*PED 2028-08-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 10092541 2034-05-29 U-2659 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 10092541 2034-05-29 U-2403 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 9872854 2034-05-29 U-2232 2018-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 9872854 2034-05-29 U-2233 2018-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 10092541*PED 2034-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 9872854*PED 2034-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 7427638*PED 2028-08-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 10092541 2034-05-29 U-2403 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 10092541 2034-05-29 U-2659 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 9872854 2034-05-29 U-2232 2018-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 9872854 2034-05-29 U-2233 2018-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 10092541*PED 2034-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 9872854*PED 2034-11-29 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 7427638*PED 2028-08-16 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 10092541 2034-05-29 U-2403 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 10092541 2034-05-29 U-2659 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 9872854 2034-05-29 U-2232 2018-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 9872854 2034-05-29 U-2233 2018-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 10092541*PED 2034-11-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 9872854*PED 2034-11-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 7427638*PED 2028-08-16 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 10092541 2034-05-29 U-2659 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 10092541 2034-05-29 U-2403 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 9872854 2034-05-29 U-2232 2018-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 9872854 2034-05-29 U-2233 2018-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 10092541*PED 2034-11-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 9872854*PED 2034-11-29 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 14 · 549 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 59572-631-06 2025-03-18 These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA ® (apremilast) tablets, for oral use Initial U.S. approval: 2014 59572-631-28 2025-03-18 These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA ® (apremilast) tablets, for oral use Initial U.S. approval: 2014 59572-631-06 2023-01-30 These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA ® (apremilast) tablets, for oral use Initial U.S. approval: 2014 59572-631-28 2023-01-30 These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA ® (apremilast) tablets, for oral use Initial U.S. approval: 2014 59572-631-06 2021-02-08 These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA ® (apremilast) tablets, for oral use Initial U.S. approval: 2014 59572-631-28 2021-02-08 These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA ® (apremilast) tablets, for oral use Initial U.S. approval: 2014 59572-631-06 2021-01-29 These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA ® (apremilast) tablets, for oral use Initial U.S. approval: 2014 59572-631-28 2021-01-29 These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA ® (apremilast) tablets, for oral use Initial U.S. approval: 2014
DailyMed Socrata Ingredients# 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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Otezla APREMILAST Amgen, Inc f6b1f516-4972-4d82-bced-113e47b41cc5 2025-12-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 205437 application number: NDA205437
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description 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