Otezla

Product NDC: 55513-516
11-digit product format: 555130516
Labeler code: 55513
Product ID: 55513-516_d869faaf-a5ad-4b12-b427-06587d17787e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: apremilast
Dosage form: KIT
Labeler: Amgen, Inc
Application: NDA205437
Marketing category: NDA
Marketing start: 2020-02-26
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Otezla
Listing expiration: 2027-12-31

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UP7QBP99PN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 18 matching rows.

Identifier, FDA.report destination table
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#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f6b1f516-4972-4d82-bced-113e47b41cc5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60f3bca3-f66c-4779-8fd1-16dc6df0a73e	Product name	6	20250818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55513-516-41	Otezla	1 in 1 CARTON	KIT	1		34
55513-516-41	Otezla	1 in 1 BLISTER PACK	KIT	1		34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55513-516-41	EA - Each	55513-516	9aca9c98-2765-4613-82f8-337066bfa241	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.

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 ndc (product): 55513-516

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55513-516-41	55513051641	1 BLISTER PACK in 1 CARTON (55513-516-41) / 1 KIT in 1 BLISTER PACK	1 blister pack	2020-02-26	No	No	Current