Copiktra

Product NDC: 71779-115
11-digit product format: 717790115
Labeler code: 71779
Product ID: 71779-115_d839b833-df53-337e-e053-2995a90a9f8b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: duvelisib
Dosage form: CAPSULE
Route: ORAL
Labeler: Verastem, 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: 2023-12-31
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	71779-115		I	Inactivated by FDA	2026-10-05
excluded package	package	71779-115	71779-115-01	I	Inactivated by FDA	2026-10-05
excluded package	package	71779-115	71779-115-02	I	Inactivated by FDA	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 · 45 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	71779-115-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71779-115-01	`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	71779-115-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71779-115-01	`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	71779-115-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71779-115-01	`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	71779-115-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71779-115-01	`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	71779-115-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71779-115-01	`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	71779-115-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71779-115-01	`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	71779-115-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71779-115-01	`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	71779-115-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71779-115-01	`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	71779-115-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71779-115-01	`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	71779-115-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71779-115-01	`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	71779-115-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71779-115-01	`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	71779-115-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71779-115-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71779-115-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71779-115-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71779-115-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71779-115-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71779-115-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71779-115-01	`1332a3947898…`	`d4bfe170f9cd…`

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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f6d81ea0-c2f8-4387-a55d-e6815cb97837	Product name	1	20181231

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71779-115-01	2024-01-30	These highlights do not include all the information needed to use COPIKTRA safely and effectively. See full prescribing information for COPIKTRA. COPIKTRA (duvelisib), capsules for oral use Initial U.S. Approval: 2018
71779-115-02	2024-01-30	These highlights do not include all the information needed to use COPIKTRA safely and effectively. See full prescribing information for COPIKTRA. COPIKTRA (duvelisib), capsules for oral use Initial U.S. Approval: 2018
71779-115-01	2022-02-17	These highlights do not include all the information needed to use COPIKTRA safely and effectively. See full prescribing information for COPIKTRA. COPIKTRA (duvelisib), capsules for oral use Initial U.S. Approval: 2018
71779-115-02	2022-02-17	These highlights do not include all the information needed to use COPIKTRA safely and effectively. See full prescribing information for COPIKTRA. COPIKTRA (duvelisib), capsules for oral use Initial U.S. Approval: 2018
71779-115-01	2022-01-28	These highlights do not include all the information needed to use COPIKTRA safely and effectively. See full prescribing information for COPIKTRA. COPIKTRA (duvelisib), capsules for oral use Initial U.S. Approval: 2018
71779-115-02	2022-01-28	These highlights do not include all the information needed to use COPIKTRA safely and effectively. See full prescribing information for COPIKTRA. COPIKTRA (duvelisib), capsules for oral use Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71779-115-01	Copiktra	56 in 1 BOTTLE	CAPSULE	56	5
71779-115-02	Copiktra	2 in 1 CARTON	CAPSULE	2	5
71779-115-03	Copiktra	1 in 1 BLISTER PACK	CAPSULE	1	5
71779-115-03	Copiktra	28 in 1 PACKAGE	CAPSULE	28	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71779-115-02	EA - Each	71779-115	1e0a21e5-1df0-4213-82e4-d530cb1b3e8f	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71779-115	COPIKTRA (DUVELISIB) CAPSULE [VERASTEM, INC.]	5	Legacy NDC, 4 package rows	20220218_47547f93-489c-4298-aeea-d6a37ca6cb1d.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2058520	Copiktra 15 MG Oral Capsule	PSN	47547f93-489c-4298-aeea-d6a37ca6cb1d	5
2058525	Copiktra 25 MG Oral Capsule	PSN	47547f93-489c-4298-aeea-d6a37ca6cb1d	5
2058514	duvelisib 15 MG Oral Capsule	PSN	47547f93-489c-4298-aeea-d6a37ca6cb1d	5
2058523	duvelisib 25 MG Oral Capsule	PSN	47547f93-489c-4298-aeea-d6a37ca6cb1d	5
2058520	duvelisib 15 MG Oral Capsule [Copiktra]	SBD	47547f93-489c-4298-aeea-d6a37ca6cb1d	5
2058525	duvelisib 25 MG Oral Capsule [Copiktra]	SBD	47547f93-489c-4298-aeea-d6a37ca6cb1d	5
2058514	duvelisib 15 MG Oral Capsule	SCD	47547f93-489c-4298-aeea-d6a37ca6cb1d	5
2058523	duvelisib 25 MG Oral Capsule	SCD	47547f93-489c-4298-aeea-d6a37ca6cb1d	5
2058520	Copiktra 15 MG Oral Capsule	SY	47547f93-489c-4298-aeea-d6a37ca6cb1d	5
2058525	Copiktra 25 MG Oral Capsule	SY	47547f93-489c-4298-aeea-d6a37ca6cb1d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71779-115-01	71779011501	56 CAPSULE in 1 BOTTLE (71779-115-01)	56 capsule	2018-09-25	0000-00-00	No	No	Current
71779-115-02	71779011502	2 PACKAGE in 1 CARTON (71779-115-02) > 28 BLISTER PACK in 1 PACKAGE (71779-115-03) > 1 CAPSULE in 1 BLISTER PACK	2 package	2018-09-25	0000-00-00	No	No	Current
71779-115-03	71779011503	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Copiktra	Verastem, Inc. \| Packaging Coordinators, Inc. \| AMRI Rensselaer, Inc. \| Catalent CTS, LLC	2022-02-11	HUMAN PRESCRIPTION DRUG LABEL	5