Lacosamide

Product NDC
53746-924
11-digit product format
537460924
Labeler code
53746
Product ID
53746-924_9ae72ba8-4a6b-4d01-b73e-0f1c9ae18711
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA204857
Marketing category
ANDA
Marketing start
2023-05-17
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 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204857-001LACOSAMIDELACOSAMIDE50MGTABLET / ORAL2022-03-17
A204857-002LACOSAMIDELACOSAMIDE100MGTABLET / ORAL2022-03-17
A204857-003LACOSAMIDELACOSAMIDE150MGTABLET / ORAL2022-03-17
A204857-004LACOSAMIDELACOSAMIDE200MGTABLET / ORAL2022-03-17

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-001LACOSAMIDE50MGTABLET / ORALAB2022-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-002LACOSAMIDE100MGTABLET / ORALAB2022-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-003LACOSAMIDE150MGTABLET / ORALAB2022-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-004LACOSAMIDE200MGTABLET / ORALAB2022-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-17d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-004AB15bbf6a4d5a75…
2024-10-29 15:01 UTC2024-10A204857-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204857-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204857-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204857-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204857-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204857-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204857-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204857-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204857-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204857-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204857-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204857-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204857-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204857-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204857-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204857-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204857-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204857-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204857-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204857-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204857-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204857-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204857-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204857-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204857-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204857-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204857-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204857-004AB15d02ea3f76ae…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204857-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204857-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204857-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204857-004AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204857-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A204857-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A204857-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A204857-004AB11c564ffb4f44…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACOSAMIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
563KS2PQY5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
809987Internal RxNorm lookup
809992Internal RxNorm lookup
809996Internal RxNorm lookup
810000Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e21389b-2f51-4975-aa21-fc5c9dd9f6dcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-924-05Lacosamide500 in 1 BOTTLETABLET5003
53746-924-60Lacosamide60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-924LACOSAMIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]3Current NDC, 2 package rows20240612_0e21389b-2f51-4975-aa21-fc5c9dd9f6dc.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LacosamideLACOSAMIDEAmneal Pharmaceuticals of New York LLC0e21389b-2f51-4975-aa21-fc5c9dd9f6dc2024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204857
application number: ANDA204857
ndc (product): 53746-924

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
809992lacosamide 150 MG Oral TabletPSN0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
809996lacosamide 200 MG Oral TabletPSN0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
810000lacosamide 50 MG Oral TabletPSN0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
809987lacosamide 100 MG Oral TabletSCD0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
809992lacosamide 150 MG Oral TabletSCD0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
809996lacosamide 200 MG Oral TabletSCD0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
810000lacosamide 50 MG Oral TabletSCD0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53746-924-0553746092405500 TABLET in 1 BOTTLE (53746-924-05) 500 tablet2023-05-17NoNoCurrent
53746-924-605374609246060 TABLET in 1 BOTTLE (53746-924-60) 60 tablet2023-05-17NoNoCurrent