Lacosamide

Product NDC: 0904-7246
11-digit product format: 009047246
Labeler code: 0904
Product ID: 0904-7246_2ced4e9b-b558-4534-bb96-99da562710a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lacosamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA214695
Marketing category: ANDA
Marketing start: 2022-04-01
Substance: LACOSAMIDE
Active strength: 150 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule: CV
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	Approval date
A214695-001	LACOSAMIDE	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31
A214695-002	LACOSAMIDE	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31
A214695-003	LACOSAMIDE	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31
A214695-004	LACOSAMIDE	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214695-001	AB
A214695-002	AB
A214695-003	AB
A214695-004	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 · 124 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
2026-08-18 06:07:40	2026-07	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 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	A214695-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214695-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214695-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214695-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214695-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214695-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214695-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214695-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214695-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214695-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214695-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214695-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LACOSAMIDE	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
563KS2PQY5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
809987	Internal RxNorm lookup
809992	Internal RxNorm lookup
809996	Internal RxNorm lookup
810000	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
c83d2156-4dde-4316-98f1-b3dc751f3eac	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
fac83aa9-21ef-4152-b501-369c0bc4765b	Product name	1	20231010
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
c8c500b5-16db-e0e3-fdf1-c683d7be70e3	Product name	3	20161117
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-7246-68	Lacosamide	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		4
0904-7246-68	Lacosamide	60 in 1 CARTON	TABLET, FILM COATED	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7246-68	EA - Each	0904-7246	19afaa60-60a7-4e61-b156-1f311479c16f	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7246	LACOSAMIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3	Current NDC, Legacy NDC, 2 package rows	20241012_c83d2156-4dde-4316-98f1-b3dc751f3eac.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lacosamide	LACOSAMIDE	REMEDYREPACK INC.	d823fbfa-8ff5-4ef8-84ce-fbe916d4e430	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214695 application number: ANDA214695
Lacosamide	LACOSAMIDE	Major Pharmaceuticals	c83d2156-4dde-4316-98f1-b3dc751f3eac	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214695 application number: ANDA214695 ndc (product): 0904-7246
Lacosamide	LACOSAMIDE	American Health Packaging	19060029-c158-4a37-9261-cfe3b2b5b1e3	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214695 application number: ANDA214695
Lacosamide	LACOSAMIDE	REMEDYREPACK INC.	8d2906e3-d059-425d-b971-29423963c2af	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214695 application number: ANDA214695
Lacosamide	LACOSAMIDE	Ascend Laboratories, LLC	9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214695 application number: ANDA214695
Lacosamide	LACOSAMIDE	Advanced Rx of Tennessee, LLC	325df1b7-4908-0c03-e063-6294a90ad844	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214695 application number: ANDA214695

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
809987	lacosamide 100 MG Oral Tablet	PSN	c83d2156-4dde-4316-98f1-b3dc751f3eac	4
809992	lacosamide 150 MG Oral Tablet	PSN	c83d2156-4dde-4316-98f1-b3dc751f3eac	4
809996	lacosamide 200 MG Oral Tablet	PSN	c83d2156-4dde-4316-98f1-b3dc751f3eac	4
810000	lacosamide 50 MG Oral Tablet	PSN	c83d2156-4dde-4316-98f1-b3dc751f3eac	4
809987	lacosamide 100 MG Oral Tablet	SCD	c83d2156-4dde-4316-98f1-b3dc751f3eac	4
809992	lacosamide 150 MG Oral Tablet	SCD	c83d2156-4dde-4316-98f1-b3dc751f3eac	4
809996	lacosamide 200 MG Oral Tablet	SCD	c83d2156-4dde-4316-98f1-b3dc751f3eac	4
810000	lacosamide 50 MG Oral Tablet	SCD	c83d2156-4dde-4316-98f1-b3dc751f3eac	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7246-68	00904724668	60 BLISTER PACK in 1 CARTON (0904-7246-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK	60 blister pack	2022-04-01	0000-00-00	No	No	Current