Lacosamide

Product NDC: 63850-0056
11-digit product format: 638500056
Labeler code: 63850
Product ID: 63850-0056_f7121f99-b30f-4286-aac0-bc9b59eb0e59
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lacosamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Natco Pharma Limited
Application: ANDA204921
Marketing category: ANDA
Marketing start: 2016-05-28
Marketing end: 0000-00-00
Substance: LACOSAMIDE
Active strength: 200 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule: CV
NDC exclude flag: E
Listing certified through: 2017-12-31
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	63850-0056		D	Discontinued by firm	2026-08-11
excluded package	package	63850-0056	63850-0056-1	D	Discontinued by firm	2026-08-11
excluded package	package	63850-0056	63850-0056-2	D	Discontinued by firm	2026-08-11

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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63850-0056-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63850-0056-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63850-0056-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63850-0056-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63850-0056-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63850-0056-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63850-0056-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63850-0056-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63850-0056-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63850-0056-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63850-0056-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63850-0056-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63850-0056-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63850-0056-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63850-0056-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63850-0056-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63850-0056-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63850-0056-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63850-0056-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63850-0056-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63850-0056-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63850-0056-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63850-0056-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63850-0056-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63850-0056-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63850-0056-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63850-0056-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63850-0056-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63850-0056-2	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63850-0056-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A204921-001	LACOSAMIDE	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17
A204921-002	LACOSAMIDE	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17
A204921-003	LACOSAMIDE	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17
A204921-004	LACOSAMIDE	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204921-001	AB
A204921-002	AB
A204921-003	AB
A204921-004	AB

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 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204921-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204921-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204921-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204921-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204921-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204921-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204921-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204921-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204921-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204921-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204921-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204921-004	AB	1	`d06236e962d9…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63850-0056-1	2022-03-25	These highlights do not include all the information needed to use LACOSAMIDE TABLETS safely and effectively. See full prescribing information for LACOSAMIDE TABLETS. LACOSAMIDE tablets, film coated for oral use, CV Initial U.S. Approval: 2008
63850-0056-2	2022-03-25	These highlights do not include all the information needed to use LACOSAMIDE TABLETS safely and effectively. See full prescribing information for LACOSAMIDE TABLETS. LACOSAMIDE tablets, film coated for oral use, CV Initial U.S. Approval: 2008
63850-0056-1	2020-01-31	These highlights do not include all the information needed to use LACOSAMIDE TABLETS safely and effectively. See full prescribing information for LACOSAMIDE TABLETS. LACOSAMIDE tablets, film coated for oral use, CV Initial U.S. Approval: 2008
63850-0056-2	2020-01-31	These highlights do not include all the information needed to use LACOSAMIDE TABLETS safely and effectively. See full prescribing information for LACOSAMIDE TABLETS. LACOSAMIDE tablets, film coated for oral use, CV Initial U.S. Approval: 2008

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LACOSAMIDE	LACOSAMIDE	Golden State Medical Supply, Inc.	f047077c-2ac7-30d0-e053-2995a90ae429	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204921 application number: ANDA204921
LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	f7ea3ce6-4ca7-4405-a011-48e7d71360a5	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204921 application number: ANDA204921
lacosamide	LACOSAMIDE	MSN LABORATORIES PRIVATE LIMITED	0ae4e2d1-305d-4045-95da-cfe7c2d8b435	2022-04-21		Exact identifier application applno (ANDA): 204921 application number: ANDA204921

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
563KS2PQY5	LACOSAMIDE	175481-36-4	LACOSAMIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lacosamide	Natco Pharma Limited \| Natco Pharma Limited-Pharma Division	2016-05-16	Human Prescription Drug Label	1