Lacosamide

Product NDC: 50268-491
11-digit product format: 502680491
Labeler code: 50268
Product ID: 50268-491_5ca5b051-08b7-2b4d-e063-6294a90a144b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lacosamide
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA208308
Marketing category: ANDA
Marketing start: 2026-09-29
Substance: LACOSAMIDE
Active strength: 50 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208308-001	LACOSAMIDE	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17
A208308-002	LACOSAMIDE	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17
A208308-003	LACOSAMIDE	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17
A208308-004	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
A208308-001	AB
A208308-002	AB
A208308-003	AB
A208308-004	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 4 · 128 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
2026-09-14 22:38:34	2026-08	A208308-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208308-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208308-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208308-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208308-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208308-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208308-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208308-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208308-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208308-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208308-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208308-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208308-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208308-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208308-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208308-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208308-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208308-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208308-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208308-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208308-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208308-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208308-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208308-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208308-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208308-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208308-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208308-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208308-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208308-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208308-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208308-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208308-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208308-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208308-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208308-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208308-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208308-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208308-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208308-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208308-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208308-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208308-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208308-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208308-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208308-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208308-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208308-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208308-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208308-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208308-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208308-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208308-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208308-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208308-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208308-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208308-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208308-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208308-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208308-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208308-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208308-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208308-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208308-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208308-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208308-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208308-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208308-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208308-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208308-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208308-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208308-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208308-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208308-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208308-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208308-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208308-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208308-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208308-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208308-004	AB	1	`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: Lacosamide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LACOSAMIDE	50 mg/1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lacosamide	LACOSAMIDE	NorthStar RxLLC	9dffda6c-9e44-478f-9e02-9da3ab4c50e1	2025-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208308 application number: ANDA208308
Lacosamide	LACOSAMIDE	Florida Pharmaceutical Products, LLC	3680c0ff-7f5c-4572-b1eb-4fea96b7fbe2	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208308 application number: ANDA208308
Lacosamide	LACOSAMIDE	Tris Pharma Inc	7f37f8b8-07d3-48c4-a0c4-7652b62a1ad9	2023-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208308 application number: ANDA208308
Lacosamide	LACOSAMIDE	Indoco Remedies Limited	145b4fae-ce6d-43e8-a474-fcb9dff92a53	2022-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208308 application number: ANDA208308

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50268-491-10	50268049110	100 BLISTER PACK in 1 BOX (50268-491-10) / 1 TABLET in 1 BLISTER PACK (50268-491-11)	100 blister pack	2026-09-29	No	No	Current