lacosamide

Product NDC: 69539-028
Requested package NDC: 69539-028-05
11-digit product format: 695390028
Labeler code: 69539
Product ID: 69539-028_421cfdea-11a0-4fd7-8b8f-79711f1e5f89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lacosamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA204921
Marketing category: ANDA
Marketing start: 2022-03-19
Substance: LACOSAMIDE
Active strength: 200 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 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
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 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	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
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…`

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	A204921-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204921-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204921-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204921-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204921-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204921-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204921-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204921-004	AB	1	`caaa826d4ba7…`
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…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LACOSAMIDE	200 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
0ae4e2d1-305d-4045-95da-cfe7c2d8b435	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	Strength	SPL version
69539-028-05	lacosamide	500 in 1 BOTTLE	TABLET, FILM COATED	500		2
69539-028-60	lacosamide	60 in 1 BOTTLE	TABLET, FILM COATED	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-028	LACOSAMIDE TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED]	2	Current NDC, Legacy NDC, 2 package rows	20220422_0ae4e2d1-305d-4045-95da-cfe7c2d8b435.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 · 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 ndc (package): 69539-028-05 ndc (product): 69539-028 ndc11 (package): 69539002805

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	0ae4e2d1-305d-4045-95da-cfe7c2d8b435	2
809992	lacosamide 150 MG Oral Tablet	PSN	0ae4e2d1-305d-4045-95da-cfe7c2d8b435	2
809996	lacosamide 200 MG Oral Tablet	PSN	0ae4e2d1-305d-4045-95da-cfe7c2d8b435	2
810000	lacosamide 50 MG Oral Tablet	PSN	0ae4e2d1-305d-4045-95da-cfe7c2d8b435	2
809987	lacosamide 100 MG Oral Tablet	SCD	0ae4e2d1-305d-4045-95da-cfe7c2d8b435	2
809992	lacosamide 150 MG Oral Tablet	SCD	0ae4e2d1-305d-4045-95da-cfe7c2d8b435	2
809996	lacosamide 200 MG Oral Tablet	SCD	0ae4e2d1-305d-4045-95da-cfe7c2d8b435	2
810000	lacosamide 50 MG Oral Tablet	SCD	0ae4e2d1-305d-4045-95da-cfe7c2d8b435	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69539-028-05	69539002805	500 TABLET, FILM COATED in 1 BOTTLE (69539-028-05)	2022-03-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LACOSAMIDE film coated tablet, for oral use, CV	MSN LABORATORIES PRIVATE LIMITED	2022-04-21	Human Prescription Drug Label	2