Xcopri

Product NDC: 71699-102
Requested package NDC: 71699-102-56
11-digit product format: 716990102
Labeler code: 71699
Product ID: 71699-102_b8c112f3-da21-419e-8ea1-c5d231f15d3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cenobamate
Dosage form: KIT
Route: ORAL
Labeler: SK Life Science, Inc.
Application: NDA212839
Marketing category: NDA
Marketing start: 2020-03-12
Marketing end: 2022-10-31
Active strength: 0
NDC exclude flag: No
Listing certified through: 0000-00-00
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	71699-102	71699-102-56	D	Discontinued by firm		2026-10-12

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 · 12 matching rows.

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

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

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N212839-001	XCOPRI	CENOBAMATE	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10
N212839-002	XCOPRI	CENOBAMATE	25MG	TABLET / ORAL	RLD	2020-03-10
N212839-003	XCOPRI	CENOBAMATE	50MG	TABLET / ORAL	RLD	2020-03-10
N212839-004	XCOPRI	CENOBAMATE	100MG	TABLET / ORAL	RLD	2020-03-10
N212839-005	XCOPRI	CENOBAMATE	150MG	TABLET / ORAL	RLD	2020-03-10
N212839-006	XCOPRI	CENOBAMATE	200MG	TABLET / ORAL	RLD	2020-03-10

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212839-001	7598279	2032-10-30		Drug substance	2020-03-12
N212839-001	11654133	2039-06-16	U-3610		2023-05-31
N212839-002	7598279	2032-10-30		Drug substance	2020-03-12
N212839-002	11654133	2039-06-16	U-3610		2023-05-31
N212839-003	7598279	2032-10-30		Drug substance	2020-03-12
N212839-003	11654133	2039-06-16	U-3610		2023-05-31
N212839-004	7598279	2032-10-30		Drug substance	2020-03-12
N212839-004	11654133	2039-06-16	U-3610		2023-05-31
N212839-005	7598279	2032-10-30		Drug substance	2020-03-12
N212839-005	11654133	2039-06-16	U-3610		2023-05-31
N212839-006	7598279	2032-10-30		Drug substance	2020-03-12
N212839-006	11654133	2039-06-16	U-3610		2023-05-31

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 6 · 234 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	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-005	XCOPRI	150MG	TABLET / ORAL	RLD	2020-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-006	XCOPRI	200MG	TABLET / ORAL	RLD	2020-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-005	XCOPRI	150MG	TABLET / ORAL	RLD	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-006	XCOPRI	200MG	TABLET / ORAL	RLD	2020-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-005	XCOPRI	150MG	TABLET / ORAL	RLD	2020-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-006	XCOPRI	200MG	TABLET / ORAL	RLD	2020-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-005	XCOPRI	150MG	TABLET / ORAL	RLD	2020-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-006	XCOPRI	200MG	TABLET / ORAL	RLD	2020-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-005	XCOPRI	150MG	TABLET / ORAL	RLD	2020-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-006	XCOPRI	200MG	TABLET / ORAL	RLD	2020-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-005	XCOPRI	150MG	TABLET / ORAL	RLD	2020-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-006	XCOPRI	200MG	TABLET / ORAL	RLD	2020-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 378 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	N212839-001	7598279	2032-10-30		Drug substance	2020-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-001	11654133	2039-06-16	U-3610		2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-002	7598279	2032-10-30		Drug substance	2020-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-002	11654133	2039-06-16	U-3610		2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-003	7598279	2032-10-30		Drug substance	2020-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-003	11654133	2039-06-16	U-3610		2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-004	7598279	2032-10-30		Drug substance	2020-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-004	11654133	2039-06-16	U-3610		2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-005	7598279	2032-10-30		Drug substance	2020-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-005	11654133	2039-06-16	U-3610		2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-006	7598279	2032-10-30		Drug substance	2020-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-006	11654133	2039-06-16	U-3610		2023-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212839-001	7598279	2032-10-30		Drug substance	2020-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-001	11654133	2039-06-16	U-3610		2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-002	7598279	2032-10-30		Drug substance	2020-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-002	11654133	2039-06-16	U-3610		2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-003	7598279	2032-10-30		Drug substance	2020-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-003	11654133	2039-06-16	U-3610		2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-004	7598279	2032-10-30		Drug substance	2020-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-004	11654133	2039-06-16	U-3610		2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-005	7598279	2032-10-30		Drug substance	2020-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-005	11654133	2039-06-16	U-3610		2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-006	7598279	2032-10-30		Drug substance	2020-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-006	11654133	2039-06-16	U-3610		2023-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212839-001	7598279	2032-10-30		Drug substance	2020-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-001	11654133	2039-06-16	U-3610		2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-002	7598279	2032-10-30		Drug substance	2020-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-002	11654133	2039-06-16	U-3610		2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-003	7598279	2032-10-30		Drug substance	2020-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-003	11654133	2039-06-16	U-3610		2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-004	7598279	2032-10-30		Drug substance	2020-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-004	11654133	2039-06-16	U-3610		2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-005	7598279	2032-10-30		Drug substance	2020-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-005	11654133	2039-06-16	U-3610		2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-006	7598279	2032-10-30		Drug substance	2020-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-006	11654133	2039-06-16	U-3610		2023-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-001	7598279	2032-10-30		Drug substance	2020-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-001	11654133	2039-06-16	U-3610		2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-002	7598279	2032-10-30		Drug substance	2020-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-002	11654133	2039-06-16	U-3610		2023-05-31	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 210 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	N212839-001	NCE	2025-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-002	NCE	2025-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-003	NCE	2025-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-004	NCE	2025-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-005	NCE	2025-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-006	NCE	2025-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212839-001	NCE	2025-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-002	NCE	2025-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-003	NCE	2025-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-004	NCE	2025-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-005	NCE	2025-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-006	NCE	2025-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-001	NCE	2025-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-002	NCE	2025-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-003	NCE	2025-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-004	NCE	2025-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-005	NCE	2025-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-006	NCE	2025-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-001	NCE	2025-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-002	NCE	2025-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-003	NCE	2025-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-004	NCE	2025-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-005	NCE	2025-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-006	NCE	2025-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212839-001	NCE	2025-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212839-002	NCE	2025-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212839-003	NCE	2025-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212839-004	NCE	2025-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212839-005	NCE	2025-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212839-006	NCE	2025-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212839-001	NCE	2025-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212839-002	NCE	2025-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212839-003	NCE	2025-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212839-004	NCE	2025-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212839-005	NCE	2025-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212839-006	NCE	2025-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212839-001	NCE	2025-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212839-002	NCE	2025-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212839-003	NCE	2025-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212839-004	NCE	2025-03-10	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71699-102-56	2020-07-22	C162847	48780-1	ab0e2407-2777-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use XCOPRI safely and effectively. See full prescribing information for XCOPRI. XCOPRI ® (cenobamate tablets), for oral use, CV Initial U.S. Approval: 2020
71699-102-56	2020-07-22	C162847	48780-1	ab0e2407-2777-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use XCOPRI safely and effectively. See full prescribing information for XCOPRI. XCOPRI ® (cenobamate tablets), for oral use, CV Initial U.S. Approval: 2020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71699-102-56	EA - Each	71699-102	1ae273f9-72bf-4dfe-b912-ac7875d44ac0	1	2020-04-20

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
Xcopri	CENOBAMATE	SK Life Science, Inc.	565c2126-57ae-4e29-b443-723bbe7e2072	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212839 application number: NDA212839

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P85X70RZWS	CENOBAMATE	913088-80-9	cenobamate

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71699-102-56	71699010256	1 KIT in 1 CARTON (71699-102-56) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK	1 kit	2020-03-12	2022-10-31	No	No	Current