LACOSAMIDE

Product NDC: 50228-193
Requested package NDC: 50228-193-30
11-digit product format: 502280193
Labeler code: 50228
Product ID: 50228-193_6cb2853d-e436-45ae-b28e-4310e1ed4be4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LACOSAMIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ScieGen Pharmaceuticals Inc
Application: ANDA205237
Marketing category: ANDA
Marketing start: 2022-03-18
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: 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
A205237-001	LACOSAMIDE	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17
A205237-002	LACOSAMIDE	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17
A205237-003	LACOSAMIDE	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17
A205237-004	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
A205237-001	AB
A205237-002	AB
A205237-003	AB
A205237-004	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	A205237-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205237-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205237-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205237-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205237-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205237-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205237-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205237-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205237-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205237-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205237-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205237-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205237-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205237-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205237-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205237-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205237-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205237-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205237-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205237-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205237-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205237-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205237-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205237-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205237-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205237-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205237-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205237-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205237-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205237-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205237-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205237-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205237-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205237-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205237-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205237-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205237-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205237-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205237-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205237-004	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	A205237-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205237-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205237-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205237-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205237-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205237-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205237-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205237-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205237-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205237-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205237-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205237-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205237-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205237-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205237-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205237-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205237-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205237-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205237-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205237-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205237-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205237-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205237-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205237-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205237-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205237-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205237-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205237-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205237-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205237-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205237-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205237-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205237-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205237-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205237-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205237-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205237-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205237-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205237-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205237-004	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	100 mg/1

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	SPL version
50228-193-10	LACOSAMIDE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	5
50228-193-30	LACOSAMIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
50228-193-60	LACOSAMIDE	60 in 1 BOTTLE	TABLET, FILM COATED	60	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50228-193-60	EA - Each	50228-193	6a5025e6-c555-4a4b-af2b-676c7fc533a5	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50228-193	LACOSAMIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC]	4	Current NDC, Legacy NDC, 3 package rows	20240616_f4ffa3ad-1278-4772-9ef8-ed6fdaa47605.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	Westminster Pharmaceuticals, LLC	ecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb86	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205237 application number: ANDA205237
LACOSAMIDE	LACOSAMIDE	ScieGen Pharmaceuticals Inc	f4ffa3ad-1278-4772-9ef8-ed6fdaa47605	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205237 application number: ANDA205237 ndc (package): 50228-193-30 ndc (product): 50228-193 ndc11 (package): 50228019330
Lacosamide	LACOSAMIDE	Proficient Rx LP	47ae2f1f-d135-4f4e-acc2-500c1afa7b8b	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205237 application number: ANDA205237

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	f4ffa3ad-1278-4772-9ef8-ed6fdaa47605	5
809992	lacosamide 150 MG Oral Tablet	PSN	f4ffa3ad-1278-4772-9ef8-ed6fdaa47605	5
809996	lacosamide 200 MG Oral Tablet	PSN	f4ffa3ad-1278-4772-9ef8-ed6fdaa47605	5
810000	lacosamide 50 MG Oral Tablet	PSN	f4ffa3ad-1278-4772-9ef8-ed6fdaa47605	5
809987	lacosamide 100 MG Oral Tablet	SCD	f4ffa3ad-1278-4772-9ef8-ed6fdaa47605	5
809992	lacosamide 150 MG Oral Tablet	SCD	f4ffa3ad-1278-4772-9ef8-ed6fdaa47605	5
809996	lacosamide 200 MG Oral Tablet	SCD	f4ffa3ad-1278-4772-9ef8-ed6fdaa47605	5
810000	lacosamide 50 MG Oral Tablet	SCD	f4ffa3ad-1278-4772-9ef8-ed6fdaa47605	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50228-193-30	50228019330	30 TABLET, FILM COATED in 1 BOTTLE (50228-193-30)	2022-03-18	0000-00-00	No	No	Current