Aptiom

Product NDC: 63402-248
11-digit product format: 634020248
Labeler code: 63402
Product ID: 63402-248_3af99c5d-50e2-4336-8a5e-e93b6cf3618a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESLICARBAZEPINE ACETATE
Dosage form: KIT
Route: ORAL
Labeler: Sumitomo Pharma America, Inc.
Application: NDA022416
Marketing category: NDA
Marketing start: 2014-04-07
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022416-001	APTIOM	ESLICARBAZEPINE ACETATE	200MG	TABLET / ORAL	AB	RLD	2013-11-08
N022416-002	APTIOM	ESLICARBAZEPINE ACETATE	400MG	TABLET / ORAL	AB	RLD	2013-11-08
N022416-003	APTIOM	ESLICARBAZEPINE ACETATE	600MG	TABLET / ORAL	AB	RLD	2013-11-08
N022416-004	APTIOM	ESLICARBAZEPINE ACETATE	800MG	TABLET / ORAL	AB	RLD, RS	2013-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022416-001	AB
N022416-002	AB
N022416-003	AB
N022416-004	AB

Orange Book patents#

Current patent rows page 1 of 1 · 32 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022416-001	9206135	2026-04-21		Drug substance	2016-05-20
N022416-001	9643929	2026-04-21		Drug product	2017-06-08
N022416-001	9763954	2028-09-13	U-2123		2017-10-10
N022416-001	10912781	2028-10-23		Drug product	2021-02-10
N022416-001	9566244	2028-10-23		Drug product	2017-03-08
N022416-001	8372431	2030-04-17		Drug product
N022416-001	9750747	2032-08-24	U-2041		2017-09-28
N022416-001	9750747	2032-08-24	U-2121		2017-09-28
N022416-002	9206135	2026-04-21		Drug substance	2016-05-20
N022416-002	9643929	2026-04-21		Drug product	2017-06-08
N022416-002	9763954	2028-09-13	U-2123		2017-10-10
N022416-002	10912781	2028-10-23		Drug product	2021-02-10
N022416-002	9566244	2028-10-23		Drug product	2017-03-08
N022416-002	8372431	2030-04-17		Drug product
N022416-002	9750747	2032-08-24	U-2041		2017-09-28
N022416-002	9750747	2032-08-24	U-2121		2017-09-28
N022416-003	9206135	2026-04-21		Drug substance	2016-05-20
N022416-003	9643929	2026-04-21		Drug product	2017-06-08
N022416-003	9763954	2028-09-13	U-2123		2017-10-10
N022416-003	10912781	2028-10-23		Drug product	2021-02-10
N022416-003	9566244	2028-10-23		Drug product	2017-03-08
N022416-003	8372431	2030-04-17		Drug product
N022416-003	9750747	2032-08-24	U-2041		2017-09-28
N022416-003	9750747	2032-08-24	U-2121		2017-09-28
N022416-004	9206135	2026-04-21		Drug substance	2016-05-20
N022416-004	9643929	2026-04-21		Drug product	2017-06-08
N022416-004	9763954	2028-09-13	U-2123		2017-10-10
N022416-004	10912781	2028-10-23		Drug product	2021-02-10
N022416-004	9566244	2028-10-23		Drug product	2017-03-08
N022416-004	8372431	2030-04-17		Drug product
N022416-004	9750747	2032-08-24	U-2041		2017-09-28
N022416-004	9750747	2032-08-24	U-2121		2017-09-28

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022416-001	APTIOM	200MG	TABLET / ORAL	AB	RLD	2013-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-002	APTIOM	400MG	TABLET / ORAL	AB	RLD	2013-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-003	APTIOM	600MG	TABLET / ORAL	AB	RLD	2013-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-004	APTIOM	800MG	TABLET / ORAL	AB	RLD, RS	2013-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022416-001	APTIOM	200MG	TABLET / ORAL	AB	RLD	2013-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-002	APTIOM	400MG	TABLET / ORAL	AB	RLD	2013-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-003	APTIOM	600MG	TABLET / ORAL	AB	RLD	2013-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-004	APTIOM	800MG	TABLET / ORAL	AB	RLD, RS	2013-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022416-001	APTIOM	200MG	TABLET / ORAL	AB	RLD	2013-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022416-002	APTIOM	400MG	TABLET / ORAL	AB	RLD	2013-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022416-003	APTIOM	600MG	TABLET / ORAL	AB	RLD	2013-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022416-004	APTIOM	800MG	TABLET / ORAL	AB	RLD, RS	2013-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022416-001	APTIOM	200MG	TABLET / ORAL	AB	RLD	2013-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022416-002	APTIOM	400MG	TABLET / ORAL	AB	RLD	2013-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022416-003	APTIOM	600MG	TABLET / ORAL	AB	RLD	2013-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022416-004	APTIOM	800MG	TABLET / ORAL	AB	RLD, RS	2013-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022416-001	APTIOM	200MG	TABLET / ORAL	AB	RLD	2013-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022416-002	APTIOM	400MG	TABLET / ORAL	AB	RLD	2013-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022416-003	APTIOM	600MG	TABLET / ORAL	AB	RLD	2013-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022416-004	APTIOM	800MG	TABLET / ORAL	AB	RLD, RS	2013-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022416-001	APTIOM	200MG	TABLET / ORAL	AB	RLD	2013-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022416-002	APTIOM	400MG	TABLET / ORAL	AB	RLD	2013-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022416-003	APTIOM	600MG	TABLET / ORAL	AB	RLD	2013-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022416-004	APTIOM	800MG	TABLET / ORAL	AB	RLD, RS	2013-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022416-001	APTIOM	200MG	TABLET / ORAL	AB	RLD	2013-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022416-002	APTIOM	400MG	TABLET / ORAL	AB	RLD	2013-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022416-003	APTIOM	600MG	TABLET / ORAL	AB	RLD	2013-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022416-004	APTIOM	800MG	TABLET / ORAL	AB	RLD, RS	2013-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022416-001	APTIOM	200MG	TABLET / ORAL	AB	RLD	2013-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022416-002	APTIOM	400MG	TABLET / ORAL	AB	RLD	2013-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022416-003	APTIOM	600MG	TABLET / ORAL	AB	RLD	2013-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022416-004	APTIOM	800MG	TABLET / ORAL	AB	RLD, RS	2013-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022416-001	APTIOM	200MG	TABLET / ORAL	AB	RLD	2013-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022416-002	APTIOM	400MG	TABLET / ORAL	AB	RLD	2013-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022416-003	APTIOM	600MG	TABLET / ORAL	AB	RLD	2013-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022416-004	APTIOM	800MG	TABLET / ORAL	AB	RLD, RS	2013-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022416-001	APTIOM	200MG	TABLET / ORAL	AB	RLD	2013-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022416-002	APTIOM	400MG	TABLET / ORAL	AB	RLD	2013-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022416-003	APTIOM	600MG	TABLET / ORAL	AB	RLD	2013-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022416-004	APTIOM	800MG	TABLET / ORAL	AB	RLD, RS	2013-11-08	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022416-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022416-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022416-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022416-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022416-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022416-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022416-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022416-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022416-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022416-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022416-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022416-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022416-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022416-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022416-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022416-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022416-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022416-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022416-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022416-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022416-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022416-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022416-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022416-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022416-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022416-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022416-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022416-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022416-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022416-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022416-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022416-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022416-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022416-004	AB	1	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 57 · 2,264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022416-001	9206135	2026-04-21		Drug substance	2016-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-001	9643929	2026-04-21		Drug product	2017-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-001	9763954	2028-09-13	U-2123		2017-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-001	10912781	2028-10-23		Drug product	2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-001	9566244	2028-10-23		Drug product	2017-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-001	8372431	2030-04-17		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-001	9750747	2032-08-24	U-2041		2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-001	9750747	2032-08-24	U-2121		2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-002	9206135	2026-04-21		Drug substance	2016-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-002	9643929	2026-04-21		Drug product	2017-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-002	9763954	2028-09-13	U-2123		2017-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-002	10912781	2028-10-23		Drug product	2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-002	9566244	2028-10-23		Drug product	2017-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-002	8372431	2030-04-17		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-002	9750747	2032-08-24	U-2121		2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-002	9750747	2032-08-24	U-2041		2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-003	9206135	2026-04-21		Drug substance	2016-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-003	9643929	2026-04-21		Drug product	2017-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-003	9763954	2028-09-13	U-2123		2017-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-003	10912781	2028-10-23		Drug product	2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-003	9566244	2028-10-23		Drug product	2017-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-003	8372431	2030-04-17		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-003	9750747	2032-08-24	U-2121		2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-003	9750747	2032-08-24	U-2041		2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-004	9206135	2026-04-21		Drug substance	2016-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-004	9643929	2026-04-21		Drug product	2017-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-004	9763954	2028-09-13	U-2123		2017-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-004	10912781	2028-10-23		Drug product	2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-004	9566244	2028-10-23		Drug product	2017-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-004	8372431	2030-04-17		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-004	9750747	2032-08-24	U-2041		2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022416-004	9750747	2032-08-24	U-2121		2017-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022416-001	9206135	2026-04-21		Drug substance	2016-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-001	9643929	2026-04-21		Drug product	2017-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-001	9763954	2028-09-13	U-2123		2017-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-001	10912781	2028-10-23		Drug product	2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-001	9566244	2028-10-23		Drug product	2017-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-001	8372431	2030-04-17		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-001	9750747	2032-08-24	U-2041		2017-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022416-001	9750747	2032-08-24	U-2121		2017-09-28	`011fe1cb6892…`

Additional Listing Data#

Finished product: Yes
Brand name base: Aptiom
Listing expiration: 2026-12-31

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BEA68ZVB2K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1482507	Internal RxNorm lookup
1482513	Internal RxNorm lookup
1482515	Internal RxNorm lookup
1482517	Internal RxNorm lookup
1482521	Internal RxNorm lookup
1482523	Internal RxNorm lookup
1482525	Internal RxNorm lookup
1482527	Internal RxNorm lookup
1491642	Internal RxNorm lookup
1491643	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
3d0c9554-eaeb-4694-8089-00133fcadce3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1d24d1d2-3014-4f74-bf96-88297667a253	Product name	3	20240906

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63402-204-17	Aptiom	7 in 1 BLISTER PACK	TABLET	7	400 mg	16
63402-208-17	Aptiom	7 in 1 BLISTER PACK	TABLET	7	800 mg	16
63402-248-14	Aptiom	1 in 1 BLISTER PACK	KIT	1		16
63402-248-56	Aptiom	4 in 1 CARTON	KIT	4		16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESLICARBAZEPINE ACETATE	ACTIVE INGREDIENT	BEA68ZVB2K	APTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUNOVION PHARMACEUTICALS INC.]	6
ESLICARBAZEPINE	ACTIVE MOIETY	S5VXA428R4	APTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUNOVION PHARMACEUTICALS INC.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	APTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUNOVION PHARMACEUTICALS INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	APTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUNOVION PHARMACEUTICALS INC.]	6
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	APTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUNOVION PHARMACEUTICALS INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63402-248	APTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUMITOMO PHARMA AMERICA, INC.]	16	Current NDC, Legacy NDC, 4 package rows	20231205_3d0c9554-eaeb-4694-8089-00133fcadce3.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
Aptiom	ESLICARBAZEPINE ACETATE	Sumitomo Pharma America, Inc.	3d0c9554-eaeb-4694-8089-00133fcadce3	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022416 application number: NDA022416 ndc (product): 63402-248

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BEA68ZVB2K	ESLICARBAZEPINE ACETATE	236395-14-5	ESLICARBAZEPINE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1491643	{7 (eslicarbazepine acetate 400 MG Oral Tablet [Aptiom]) / 7 (eslicarbazepine acetate 800 MG Oral Tablet [Aptiom]) } Pack [Aptiom Titration Sample Pack]	BPCK	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1491642	{7 (eslicarbazepine acetate 400 MG Oral Tablet) / 7 (eslicarbazepine acetate 800 MG Oral Tablet) } Pack	GPCK	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482513	Aptiom 200 MG Oral Tablet, Once Daily	PSN	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482517	Aptiom 400 MG Oral Tablet, Once Daily	PSN	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482523	Aptiom 600 MG Oral Tablet, Once Daily	PSN	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482527	Aptiom 800 MG Oral Tablet, Once Daily	PSN	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1491643	Aptiom Titration Sample Pack	PSN	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482507	eslicarbazepine acetate 200 MG Oral Tablet	PSN	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1491642	eslicarbazepine acetate 400 MG (7) / eslicarbazepine acetate 800 MG (7) Pack	PSN	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482515	eslicarbazepine acetate 400 MG Oral Tablet	PSN	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482521	eslicarbazepine acetate 600 MG Oral Tablet	PSN	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482525	eslicarbazepine acetate 800 MG Oral Tablet	PSN	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482513	eslicarbazepine acetate 200 MG Oral Tablet [Aptiom]	SBD	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482517	eslicarbazepine acetate 400 MG Oral Tablet [Aptiom]	SBD	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482523	eslicarbazepine acetate 600 MG Oral Tablet [Aptiom]	SBD	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482527	eslicarbazepine acetate 800 MG Oral Tablet [Aptiom]	SBD	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482507	eslicarbazepine acetate 200 MG Oral Tablet	SCD	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482515	eslicarbazepine acetate 400 MG Oral Tablet	SCD	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482521	eslicarbazepine acetate 600 MG Oral Tablet	SCD	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482525	eslicarbazepine acetate 800 MG Oral Tablet	SCD	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482513	Aptiom 200 MG Oral Tablet	SY	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482517	Aptiom 400 MG Oral Tablet	SY	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482523	Aptiom 600 MG Oral Tablet	SY	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1482527	Aptiom 800 MG Oral Tablet	SY	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1491643	Aptiom Titration Sample Pack	SY	3d0c9554-eaeb-4694-8089-00133fcadce3	16
1491642	Titration Sample Pack (7 eslicarbazepine acetate 400 MG Oral Tablet / 7 eslicarbazepine acetate 800 MG Oral Tablet)	SY	3d0c9554-eaeb-4694-8089-00133fcadce3	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63402-204-17	63402020417	7 in 1 BLISTER PACK						Historical
63402-208-17	63402020817	7 in 1 BLISTER PACK						Historical
63402-248-14	63402024814	1 in 1 BLISTER PACK						Historical
63402-248-56	63402024856	4 BLISTER PACK in 1 CARTON (63402-248-56) / 1 KIT in 1 BLISTER PACK (63402-248-14) * 7 TABLET in 1 BLISTER PACK (63402-204-17) * 7 TABLET in 1 BLISTER PACK (63402-208-17)	4 blister pack	2014-04-07	0000-00-00	No	No	Current