OTEZLA

Product NDC: 59572-632
Requested package NDC: 59572-632-55
11-digit product format: 595720632
Labeler code: 59572
Product ID: 59572-632_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: 2015-02-01
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59572-632	59572-632-55	D	Discontinued by firm		2026-08-11

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.

Application-product, TE code table
Application-product	TE code
N205437-001	AB
N205437-002	AB
N205437-003	AB

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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205437-001	ODE-248	2026-07-19
N205437-001	M-299	2026-07-20
N205437-001	PED	2027-01-19
N205437-001	PED	2027-01-20
N205437-001	NPP	2027-04-25
N205437-001	PED	2027-10-25
N205437-002	ODE-248	2026-07-19
N205437-002	M-299	2026-07-20
N205437-002	PED	2027-01-19
N205437-002	PED	2027-01-20
N205437-002	NPP	2027-04-25
N205437-002	PED	2027-10-25
N205437-003	ODE-248	2026-07-19
N205437-003	M-299	2026-07-20
N205437-003	PED	2027-01-19
N205437-003	PED	2027-01-20
N205437-003	NPP	2027-04-25
N205437-003	PED	2027-10-25

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205437-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205437-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205437-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205437-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205437-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205437-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205437-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205437-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205437-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205437-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205437-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205437-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205437-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205437-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205437-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205437-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205437-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205437-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205437-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205437-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205437-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205437-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205437-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205437-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205437-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205437-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205437-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205437-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205437-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205437-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205437-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205437-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205437-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205437-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205437-001	AB	1	`8072bd15b7f6…`

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205437-001	ODE-248	2026-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-001	M-299	2026-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-001	PED	2027-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-001	PED	2027-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-001	NPP	2027-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-001	PED	2027-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-002	ODE-248	2026-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-002	M-299	2026-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-002	PED	2027-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-002	PED	2027-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-002	NPP	2027-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-002	PED	2027-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-003	ODE-248	2026-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-003	M-299	2026-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-003	PED	2027-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-003	PED	2027-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-003	NPP	2027-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-003	PED	2027-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-001	ODE-248	2026-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-001	M-299	2026-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-001	PED	2027-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-001	PED	2027-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-001	NPP	2027-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-001	PED	2027-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-002	ODE-248	2026-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-002	M-299	2026-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-002	PED	2027-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-002	PED	2027-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-002	NPP	2027-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-002	PED	2027-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-003	ODE-248	2026-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-003	M-299	2026-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-003	PED	2027-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-003	PED	2027-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-003	NPP	2027-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-003	PED	2027-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205437-001	ODE-248	2026-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205437-001	M-299	2026-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205437-001	PED	2027-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205437-001	PED	2027-01-20	`6a471c1ec25d…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
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
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
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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59572-632-55	EA - Each	59572-632	0579f763-2381-4c78-b96d-d17285eb0b3e	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
APREMILAST	ACTIVE INGREDIENT	UP7QBP99PN	OTEZLA (APREMILAST) KIT OTEZLA (APREMILAST) TABLET, FILM COATED [CELGENE CORPORATION]	10
APREMILAST	ACTIVE MOIETY	UP7QBP99PN	OTEZLA (APREMILAST) KIT OTEZLA (APREMILAST) TABLET, FILM COATED [CELGENE CORPORATION]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OTEZLA (APREMILAST) KIT OTEZLA (APREMILAST) TABLET, FILM COATED [CELGENE CORPORATION]	10
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	OTEZLA (APREMILAST) KIT OTEZLA (APREMILAST) TABLET, FILM COATED [CELGENE CORPORATION]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OTEZLA (APREMILAST) KIT OTEZLA (APREMILAST) TABLET, FILM COATED [CELGENE CORPORATION]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OTEZLA (APREMILAST) KIT OTEZLA (APREMILAST) TABLET, FILM COATED [CELGENE CORPORATION]	10

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UP7QBP99PN	APREMILAST	608141-41-9	apremilast

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59572-632-55	59572063255	1 KIT in 1 BLISTER PACK (59572-632-55)	1 kit	2015-08-05	0000-00-00	No	No	Current