Lacosamide

Product NDC: 70518-4505
Requested package NDC: 70518-4505-0
11-digit product format: 705184505
Labeler code: 70518
Product ID: 70518-4505_4120061a-dbb2-8918-e063-6394a90afbf2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lacosamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA204974
Marketing category: ANDA
Marketing start: 2025-10-14
Substance: LACOSAMIDE
Active strength: 100 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 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
A204974-001	LACOSAMIDE	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17
A204974-002	LACOSAMIDE	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17
A204974-003	LACOSAMIDE	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17
A204974-004	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
A204974-001	AB
A204974-002	AB
A204974-003	AB
A204974-004	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	A204974-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204974-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204974-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204974-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204974-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204974-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204974-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204974-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204974-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204974-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204974-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204974-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204974-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204974-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204974-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204974-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204974-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204974-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204974-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204974-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204974-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204974-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204974-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204974-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204974-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204974-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204974-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204974-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204974-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204974-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204974-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204974-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204974-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204974-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204974-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204974-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204974-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204974-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204974-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204974-004	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	A204974-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204974-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204974-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204974-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204974-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204974-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204974-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204974-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204974-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204974-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204974-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204974-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204974-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204974-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204974-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204974-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204974-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204974-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204974-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204974-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204974-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204974-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204974-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204974-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204974-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204974-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204974-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204974-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204974-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204974-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204974-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204974-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204974-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204974-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204974-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204974-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204974-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204974-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204974-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204974-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LACOSAMIDE	100 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
809987	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
ae9f4f1b-574d-4c9a-80cb-189ccb232723	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fac83aa9-21ef-4152-b501-369c0bc4765b	Product name	1	20231010
c8c500b5-16db-e0e3-fdf1-c683d7be70e3	Product name	3	20161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4505-0	Lacosamide	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lacosamide	LACOSAMIDE	REMEDYREPACK INC.	edd20b60-6265-4c4e-a95a-aaf8103cd852	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204974 application number: ANDA204974
Lacosamide	LACOSAMIDE	REMEDYREPACK INC.	e3658b3c-f193-41a2-acc7-0bb912e27173	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204974 application number: ANDA204974
Lacosamide	LACOSAMIDE	REMEDYREPACK INC.	ae9f4f1b-574d-4c9a-80cb-189ccb232723	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204974 application number: ANDA204974 ndc (package): 70518-4505-0 ndc (product): 70518-4505 ndc11 (package): 70518450500
Lacosamide	LACOSAMIDE	Alembic Pharmaceuticals Inc.	07b7b3f2-16a0-4deb-883b-10522676d966	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204974 application number: ANDA204974
Lacosamide	LACOSAMIDE	Alembic Pharmaceuticals Limited	46b98d5e-fdb6-483a-b022-8b1f0aa832c5	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204974 application number: ANDA204974

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	ae9f4f1b-574d-4c9a-80cb-189ccb232723	1
809987	lacosamide 100 MG Oral Tablet	SCD	ae9f4f1b-574d-4c9a-80cb-189ccb232723	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4505-0	70518450500	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4505-0)	2025-10-14	No	No	Current