Xcopri

Product NDC: 71699-100
11-digit product format: 716990100
Labeler code: 71699
Product ID: 71699-100_a4bdf970-9ffa-11f1-b55a-0800200c9a66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cenobamate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: SK Life Science, Inc.
Application: NDA212839
Marketing category: NDA
Marketing start: 2020-03-12
Substance: CENOBAMATE
Active strength: 100 mg/1
Pharmacologic classes: Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], GABA A Receptor Positive Modulators [MoA], Sodium Channel Antagonists [MoA]
DEA schedule: CV
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 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.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CENOBAMATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P85X70RZWS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 24 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2265695	Internal RxNorm lookup
2265701	Internal RxNorm lookup
2283503	Internal RxNorm lookup
2283505	Internal RxNorm lookup
2283507	Internal RxNorm lookup
2283509	Internal RxNorm lookup
2283511	Internal RxNorm lookup
2283513	Internal RxNorm lookup
2283517	Internal RxNorm lookup
2283518	Internal RxNorm lookup
2283520	Internal RxNorm lookup
2283522	Internal RxNorm lookup
2283523	Internal RxNorm lookup
2283525	Internal RxNorm lookup
2283527	Internal RxNorm lookup
2283535	Internal RxNorm lookup
2283536	Internal RxNorm lookup
2283538	Internal RxNorm lookup
2283539	Internal RxNorm lookup
2283540	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
565c2126-57ae-4e29-b443-723bbe7e2072	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bfc06707-697c-4c73-94f1-ce1fe39a2a97	Product name	1	20200506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71699-100-30	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
71699-100-30	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71699-100-30	Xcopri	30 in 1 BOTTLE	TABLET, FILM COATED	30		43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71699-100-30	EA - Each	71699-100	32eab742-e841-45a8-98f6-245d9376b17e	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71699-100	XCOPRI TITRATION PACK (CENOBAMATE) KIT XCOPRI (CENOBAMATE) TABLET, FILM COATED XCOPRI MAINTENANCE PACK (CENOBAMATE) KIT XCOPRI (CENOBAMATE) TABLET [SK LIFE SCIENCE, INC.]	36	Current NDC, Legacy NDC, 1 package rows	20250510_565c2126-57ae-4e29-b443-723bbe7e2072.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
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 ndc (product): 71699-100

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2283536	{14 (cenobamate 100 MG Oral Tablet [Xcopri]) / 14 (cenobamate 50 MG Oral Tablet [Xcopri]) } Pack [Xcopri Titration Pack - 50 MG (14), 100 MG (14) 28 Count]	BPCK	565c2126-57ae-4e29-b443-723bbe7e2072	43
2683674	{14 (cenobamate 12.5 MG Oral Tablet [Xcopri]) } Pack [Xcopri Titration Pack - 12.5 MG 14 Count]	BPCK	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283538	{14 (cenobamate 12.5 MG Oral Tablet [Xcopri]) / 14 (cenobamate 25 MG Oral Tablet [Xcopri]) } Pack [Xcopri Titration Pack - 12.5 MG (14), 25 MG (14) 28 Count]	BPCK	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283540	{14 (cenobamate 150 MG Oral Tablet [Xcopri]) / 14 (cenobamate 200 MG Oral Tablet [Xcopri]) } Pack [Xcopri Titration Pack - 150 MG (14), 200 MG (14) 28 Count]	BPCK	565c2126-57ae-4e29-b443-723bbe7e2072	43
2540432	{28 (cenobamate 100 MG Oral Tablet [Xcopri]) / 28 (cenobamate 150 MG Oral Tablet [Xcopri]) } Pack [Xcopri 250 MG Maintenance Pack - 100 MG (28), 150 MG (28) 56 Count]	BPCK	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283518	{28 (cenobamate 150 MG Oral Tablet [Xcopri]) / 28 (cenobamate 200 MG Oral Tablet) } Pack [Xcopri 350 MG Maintenance Pack]	BPCK	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283535	{14 (cenobamate 100 MG Oral Tablet) / 14 (cenobamate 50 MG Oral Tablet) } Pack	GPCK	565c2126-57ae-4e29-b443-723bbe7e2072	43
2683673	{14 (cenobamate 12.5 MG Oral Tablet) } Pack	GPCK	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283523	{14 (cenobamate 12.5 MG Oral Tablet) / 14 (cenobamate 25 MG Oral Tablet) } Pack	GPCK	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283539	{14 (cenobamate 150 MG Oral Tablet) / 14 (cenobamate 200 MG Oral Tablet) } Pack	GPCK	565c2126-57ae-4e29-b443-723bbe7e2072	43
2540431	{28 (cenobamate 100 MG Oral Tablet) / 28 (cenobamate 150 MG Oral Tablet) } Pack	GPCK	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283517	{28 (cenobamate 150 MG Oral Tablet) / 28 (cenobamate 200 MG Oral Tablet) } Pack	GPCK	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283503	cenobamate 100 MG Oral Tablet	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2540431	cenobamate 100 MG Oral Tablet (28) / cenobamate 150 MG Oral Tablet (28) Maintenance Pack	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283520	cenobamate 12.5 MG Oral Tablet	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283523	cenobamate 12.5 MG Oral Tablet (14) / cenobamate 25 MG Oral Tablet (14) Titration Pack	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283507	cenobamate 150 MG Oral Tablet	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283539	cenobamate 150 MG Oral Tablet (14) / cenobamate 200 MG Oral Tablet (14) Titration Pack	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283517	cenobamate 150 MG Oral Tablet (28) / cenobamate 200 MG Oral Tablet (28) Maintenance Pack	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283511	cenobamate 200 MG Oral Tablet	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283522	cenobamate 25 MG Oral Tablet	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2265695	cenobamate 50 MG Oral Tablet	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283535	cenobamate 50 MG Oral Tablet (14) / cenobamate 100 MG Oral Tablet (14) Titration Pack	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2683673	cenobamate Titration Pack - 12.5 MG 14 Count	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283505	XCOPRI 100 MG Oral Tablet	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283525	XCOPRI 12.5 MG Oral Tablet	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283509	XCOPRI 150 MG Oral Tablet	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283513	XCOPRI 200 MG Oral Tablet	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283527	XCOPRI 25 MG Oral Tablet	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2540432	XCOPRI 250 MG Maintenance Pack - 100 MG (28), 150 MG (28) 56 Count	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283518	XCOPRI 350 MG Maintenance Pack	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2265701	XCOPRI 50 MG Oral Tablet	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283538	XCOPRI Titration Pack - 12.5 MG (14), 25 MG (14) 28 Count	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2683674	XCOPRI Titration Pack - 12.5 MG 14 Count	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283540	XCOPRI Titration Pack - 150 MG (14), 200 MG (14) 28 Count	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283536	XCOPRI Titration Pack - 50 MG (14), 100 MG (14) 28 Count	PSN	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283505	cenobamate 100 MG Oral Tablet [Xcopri]	SBD	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283525	cenobamate 12.5 MG Oral Tablet [Xcopri]	SBD	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283509	cenobamate 150 MG Oral Tablet [Xcopri]	SBD	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283513	cenobamate 200 MG Oral Tablet [Xcopri]	SBD	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283527	cenobamate 25 MG Oral Tablet [Xcopri]	SBD	565c2126-57ae-4e29-b443-723bbe7e2072	43
2265701	cenobamate 50 MG Oral Tablet [Xcopri]	SBD	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283503	cenobamate 100 MG Oral Tablet	SCD	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283520	cenobamate 12.5 MG Oral Tablet	SCD	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283507	cenobamate 150 MG Oral Tablet	SCD	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283511	cenobamate 200 MG Oral Tablet	SCD	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283522	cenobamate 25 MG Oral Tablet	SCD	565c2126-57ae-4e29-b443-723bbe7e2072	43
2265695	cenobamate 50 MG Oral Tablet	SCD	565c2126-57ae-4e29-b443-723bbe7e2072	43
2540431	cenobamate 100 MG Oral Tablet (28) / cenobamate 150 MG Oral Tablet (28) Maintenance Pack	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283523	cenobamate 12.5 MG Oral Tablet (14) / cenobamate 25 MG Oral Tablet (14) Titration Pack	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283539	cenobamate 150 MG Oral Tablet (14) / cenobamate 200 MG Oral Tablet (14) Titration Pack	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283517	cenobamate 150 MG Oral Tablet (28) / cenobamate 200 MG Oral Tablet (28) Maintenance Pack	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283535	cenobamate 50 MG Oral Tablet (14) / cenobamate 100 MG Oral Tablet (14) Titration Pack	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2683673	cenobamate Titration Pack - 12.5 MG 14 Count	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283505	Xcopri 100 MG Oral Tablet	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283525	Xcopri 12.5 MG Oral Tablet	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283509	Xcopri 150 MG Oral Tablet	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283513	Xcopri 200 MG Oral Tablet	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283527	Xcopri 25 MG Oral Tablet	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2540432	Xcopri 250 MG Maintenance Pack - 100 MG (28), 150 MG (28) 56 Count	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283518	Xcopri 350 MG Maintenance Pack	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2265701	Xcopri 50 MG Oral Tablet	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283538	Xcopri Titration Pack - 12.5 MG (14), 25 MG (14) 28 Count	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2683674	Xcopri Titration Pack - 12.5 MG 14 Count	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283540	Xcopri Titration Pack - 150 MG (14), 200 MG (14) 28 Count	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43
2283536	Xcopri Titration Pack - 50 MG (14), 100 MG (14) 28 Count	SY	565c2126-57ae-4e29-b443-723bbe7e2072	43

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71699-100-30	71699010030	30 TABLET, FILM COATED in 1 BOTTLE (71699-100-30)	2020-03-12	0000-00-00	No	No	Current