COPIKTRA

Product NDC: 73116-115
11-digit product format: 731160115
Labeler code: 73116
Product ID: 73116-115_b2586d9d-9395-46d3-a0ff-d64c0ecb8e21
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: duvelisib
Dosage form: CAPSULE
Route: ORAL
Labeler: Secura Bio, Inc.
Application: NDA211155
Marketing category: NDA
Marketing start: 2018-09-25
Marketing end: 0000-00-00
Substance: DUVELISIB
Active strength: 15 mg/1
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	73116-115		D	Discontinued by firm	2026-10-05
excluded package	package	73116-115	73116-115-01	D	Discontinued by firm	2026-10-05
excluded package	package	73116-115	73116-115-02	D	Discontinued by firm	2026-10-05

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73116-115-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73116-115-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73116-115-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73116-115-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73116-115-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73116-115-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73116-115-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73116-115-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73116-115-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73116-115-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73116-115-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73116-115-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73116-115-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73116-115-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73116-115-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73116-115-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73116-115-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73116-115-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73116-115-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73116-115-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73116-115-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73116-115-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73116-115-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73116-115-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N211155-001	COPIKTRA	DUVELISIB	15MG	CAPSULE / ORAL		RLD	2018-09-24
N211155-002	COPIKTRA	DUVELISIB	25MG	CAPSULE / ORAL		RLD	2018-09-24

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211155-001	9216982	2029-01-05	U-2412		2018-10-23
N211155-001	9216982	2029-01-05	U-2413		2018-10-23
N211155-001	11312718	2032-01-10		Drug product	2022-06-03
N211155-001	9840505	2032-01-10	U-2412		2018-10-23
N211155-001	9840505	2032-01-10	U-2413		2018-10-23
N211155-001	RE46621	2032-05-17		Drug substance, Drug product	2018-10-23
N211155-001	8193182	2032-09-24		Drug substance	2018-10-23
N211155-001	12213983	2035-04-26	U-2412		2025-03-05
N211155-002	9216982	2029-01-05	U-2412		2018-10-23
N211155-002	9216982	2029-01-05	U-2413		2018-10-23
N211155-002	11312718	2032-01-10		Drug product	2022-06-03
N211155-002	9840505	2032-01-10	U-2412		2018-10-23
N211155-002	9840505	2032-01-10	U-2413		2018-10-23
N211155-002	RE46621	2032-05-17		Drug substance, Drug product	2018-10-23
N211155-002	8193182	2032-09-24		Drug substance	2018-10-23
N211155-002	12213983	2035-04-26	U-2412		2025-03-05

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD	2018-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD, RS	2018-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD, RS	2018-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211155-001	COPIKTRA	15MG	CAPSULE / ORAL	RLD	2018-09-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N211155-002	COPIKTRA	25MG	CAPSULE / ORAL	RLD, RS	2018-09-24	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 592 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211155-001	9216982	2029-01-05	U-2413		2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-001	9216982	2029-01-05	U-2412		2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-001	11312718	2032-01-10		Drug product	2022-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-001	9840505	2032-01-10	U-2413		2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-001	9840505	2032-01-10	U-2412		2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-001	RE46621	2032-05-17		Drug substance, Drug product	2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-001	8193182	2032-09-24		Drug substance	2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-001	12213983	2035-04-26	U-2412		2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-002	9216982	2029-01-05	U-2413		2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-002	9216982	2029-01-05	U-2412		2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-002	11312718	2032-01-10		Drug product	2022-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-002	9840505	2032-01-10	U-2412		2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-002	9840505	2032-01-10	U-2413		2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-002	RE46621	2032-05-17		Drug substance, Drug product	2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-002	8193182	2032-09-24		Drug substance	2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211155-002	12213983	2035-04-26	U-2412		2025-03-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211155-001	9216982	2029-01-05	U-2413		2018-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-001	9216982	2029-01-05	U-2412		2018-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-001	11312718	2032-01-10		Drug product	2022-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-001	9840505	2032-01-10	U-2413		2018-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-001	9840505	2032-01-10	U-2412		2018-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-001	RE46621	2032-05-17		Drug substance, Drug product	2018-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-001	8193182	2032-09-24		Drug substance	2018-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-001	12213983	2035-04-26	U-2412		2025-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-002	9216982	2029-01-05	U-2413		2018-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-002	9216982	2029-01-05	U-2412		2018-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-002	11312718	2032-01-10		Drug product	2022-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-002	9840505	2032-01-10	U-2412		2018-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-002	9840505	2032-01-10	U-2413		2018-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-002	RE46621	2032-05-17		Drug substance, Drug product	2018-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-002	8193182	2032-09-24		Drug substance	2018-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211155-002	12213983	2035-04-26	U-2412		2025-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211155-001	9216982	2029-01-05	U-2413		2018-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211155-001	9216982	2029-01-05	U-2412		2018-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211155-001	8193182	2030-02-13		Drug substance	2018-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211155-001	11312718	2032-01-10		Drug product	2022-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211155-001	9840505	2032-01-10	U-2413		2018-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211155-001	9840505	2032-01-10	U-2412		2018-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211155-001	RE46621	2032-05-17		Drug substance, Drug product	2018-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211155-001	12213983	2035-04-26	U-2412		2025-03-05	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 154 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211155-001	ODE-208	2025-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211155-002	ODE-208	2025-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211155-001	ODE-208	2025-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211155-002	ODE-208	2025-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211155-001	ODE-208	2025-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211155-002	ODE-208	2025-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211155-001	ODE-208	2025-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211155-002	ODE-208	2025-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211155-001	ODE-208	2025-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211155-002	ODE-208	2025-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211155-001	ODE-208	2025-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211155-002	ODE-208	2025-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211155-001	ODE-208	2025-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211155-002	ODE-208	2025-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211155-001	ODE-208	2025-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211155-002	ODE-208	2025-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211155-001	ODE-208	2025-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211155-002	ODE-208	2025-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211155-001	ODE-208	2025-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211155-002	ODE-208	2025-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211155-001	ODE-208	2025-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211155-002	ODE-208	2025-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211155-001	ODE-208	2025-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211155-002	ODE-208	2025-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211155-001	ODE-208	2025-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211155-002	ODE-208	2025-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211155-001	NCE	2023-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211155-001	ODE-208	2025-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211155-001	ODE-209	2025-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211155-002	NCE	2023-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211155-002	ODE-208	2025-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211155-002	ODE-209	2025-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211155-001	NCE	2023-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211155-001	ODE-208	2025-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211155-001	ODE-209	2025-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211155-002	NCE	2023-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211155-002	ODE-208	2025-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211155-002	ODE-209	2025-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211155-001	NCE	2023-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211155-001	ODE-208	2025-09-24	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
COPIKTRA	DUVELISIB	Secura Bio, Inc	e3c5ac56-e1f6-473a-bc73-687836534780	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211155 application number: NDA211155

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
610V23S0JI	DUVELISIB	1201438-56-3	DUVELISIB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73116-115-01	73116011501	56 CAPSULE in 1 BOTTLE (73116-115-01)	56 capsule	2018-09-25	0000-00-00	No	No	Current
73116-115-02	73116011502	2 PACKAGE in 1 CARTON (73116-115-02) > 28 BLISTER PACK in 1 PACKAGE (73116-115-03) > 1 CAPSULE in 1 BLISTER PACK	2 package	2018-09-25	0000-00-00	No	No	Current