Lacosamide

Product NDC: 62332-171
11-digit product format: 623320171
Labeler code: 62332
Product ID: 62332-171_50c42e50-ab11-460a-a8f6-0edcd1b91613
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lacosamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA204974
Marketing category: ANDA
Marketing start: 2022-03-18
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: 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
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 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	A204974-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204974-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204974-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204974-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
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…`

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	A204974-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204974-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204974-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204974-004	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LACOSAMIDE	50 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
07b7b3f2-16a0-4deb-883b-10522676d966	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
c8c500b5-16db-e0e3-fdf1-c683d7be70e3	Product name	3	20161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62332-171-10	Lacosamide	100 in 1 CARTON	TABLET, FILM COATED	100	14
62332-171-10	Lacosamide	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	14
62332-171-30	Lacosamide	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
62332-171-60	Lacosamide	60 in 1 BOTTLE	TABLET, FILM COATED	60	14
62332-171-91	Lacosamide	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62332-171-60	EA - Each	62332-171	3329697c-5274-45e0-bab0-853c5f9eebca	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62332-171	LACOSAMIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]	14	Current NDC, Legacy NDC, 5 package rows	20231202_07b7b3f2-16a0-4deb-883b-10522676d966.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 · 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
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 ndc (product): 62332-171
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	07b7b3f2-16a0-4deb-883b-10522676d966	14
809992	lacosamide 150 MG Oral Tablet	PSN	07b7b3f2-16a0-4deb-883b-10522676d966	14
809996	lacosamide 200 MG Oral Tablet	PSN	07b7b3f2-16a0-4deb-883b-10522676d966	14
810000	lacosamide 50 MG Oral Tablet	PSN	07b7b3f2-16a0-4deb-883b-10522676d966	14
809987	lacosamide 100 MG Oral Tablet	SCD	07b7b3f2-16a0-4deb-883b-10522676d966	14
809992	lacosamide 150 MG Oral Tablet	SCD	07b7b3f2-16a0-4deb-883b-10522676d966	14
809996	lacosamide 200 MG Oral Tablet	SCD	07b7b3f2-16a0-4deb-883b-10522676d966	14
810000	lacosamide 50 MG Oral Tablet	SCD	07b7b3f2-16a0-4deb-883b-10522676d966	14
810000	lacosamide 50 MG Oral Tablet	PSN	e3658b3c-f193-41a2-acc7-0bb912e27173	1
810000	lacosamide 50 MG Oral Tablet	SCD	e3658b3c-f193-41a2-acc7-0bb912e27173	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62332-171-10	62332017110	100 BLISTER PACK in 1 CARTON (62332-171-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	100 blister pack	2022-03-18	0000-00-00	No	No	Current
62332-171-30	62332017130	30 TABLET, FILM COATED in 1 BOTTLE (62332-171-30)		2022-03-18	0000-00-00	No	No	Current
62332-171-60	62332017160	60 TABLET, FILM COATED in 1 BOTTLE (62332-171-60)		2022-03-18	0000-00-00	No	No	Current
62332-171-91	62332017191	1000 TABLET, FILM COATED in 1 BOTTLE (62332-171-91)		2022-03-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lacosamide	REMEDYREPACK INC.	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	1
Lacosamide	Alembic Pharmaceuticals Inc. \| Alembic Pharmaceuticals Limited	2023-11-09	Human Prescription Drug Label	14