Lacosamide

Product NDC
85742-011
11-digit product format
857420011
Labeler code
85742
Product ID
85742-011_9e55b694-312b-480c-a20f-a6ed325906d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kanchan Healthcare Inc
Application
ANDA218014
Marketing category
ANDA
Marketing start
2025-07-01
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218014-001LACOSAMIDELACOSAMIDE50MGTABLET / ORALAB2024-04-02
A218014-002LACOSAMIDELACOSAMIDE100MGTABLET / ORALAB2024-04-02
A218014-003LACOSAMIDELACOSAMIDE150MGTABLET / ORALAB2024-04-02
A218014-004LACOSAMIDELACOSAMIDE200MGTABLET / ORALAB2024-04-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A218014-001AB
A218014-002AB
A218014-003AB
A218014-004AB

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 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218014-001LACOSAMIDE50MGTABLET / ORALAB2024-04-0284e616aacf4f…
2026-09-14 22:38:342026-08A218014-002LACOSAMIDE100MGTABLET / ORALAB2024-04-0284e616aacf4f…
2026-09-14 22:38:342026-08A218014-003LACOSAMIDE150MGTABLET / ORALAB2024-04-0284e616aacf4f…
2026-09-14 22:38:342026-08A218014-004LACOSAMIDE200MGTABLET / ORALAB2024-04-0284e616aacf4f…
2026-08-18 06:07:402026-07A218014-001LACOSAMIDE50MGTABLET / ORALAB2024-04-02caaa826d4ba7…
2026-08-18 06:07:402026-07A218014-002LACOSAMIDE100MGTABLET / ORALAB2024-04-02caaa826d4ba7…
2026-08-18 06:07:402026-07A218014-003LACOSAMIDE150MGTABLET / ORALAB2024-04-02caaa826d4ba7…
2026-08-18 06:07:402026-07A218014-004LACOSAMIDE200MGTABLET / ORALAB2024-04-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218014-001LACOSAMIDE50MGTABLET / ORALAB2024-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218014-002LACOSAMIDE100MGTABLET / ORALAB2024-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218014-003LACOSAMIDE150MGTABLET / ORALAB2024-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218014-004LACOSAMIDE200MGTABLET / ORALAB2024-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218014-001LACOSAMIDE50MGTABLET / ORALAB2024-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218014-002LACOSAMIDE100MGTABLET / ORALAB2024-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218014-003LACOSAMIDE150MGTABLET / ORALAB2024-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218014-004LACOSAMIDE200MGTABLET / ORALAB2024-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A218014-001LACOSAMIDE50MGTABLET / ORALAB2024-04-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218014-002LACOSAMIDE100MGTABLET / ORALAB2024-04-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218014-003LACOSAMIDE150MGTABLET / ORALAB2024-04-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218014-004LACOSAMIDE200MGTABLET / ORALAB2024-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218014-001LACOSAMIDE50MGTABLET / ORALAB2024-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218014-002LACOSAMIDE100MGTABLET / ORALAB2024-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218014-003LACOSAMIDE150MGTABLET / ORALAB2024-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218014-004LACOSAMIDE200MGTABLET / ORALAB2024-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218014-001LACOSAMIDE50MGTABLET / ORALAB2024-04-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218014-002LACOSAMIDE100MGTABLET / ORALAB2024-04-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218014-003LACOSAMIDE150MGTABLET / ORALAB2024-04-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218014-004LACOSAMIDE200MGTABLET / ORALAB2024-04-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218014-001LACOSAMIDE50MGTABLET / ORALAB2024-04-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218014-002LACOSAMIDE100MGTABLET / ORALAB2024-04-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218014-003LACOSAMIDE150MGTABLET / ORALAB2024-04-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218014-004LACOSAMIDE200MGTABLET / ORALAB2024-04-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218014-001LACOSAMIDE50MGTABLET / ORALAB2024-04-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218014-002LACOSAMIDE100MGTABLET / ORALAB2024-04-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218014-003LACOSAMIDE150MGTABLET / ORALAB2024-04-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218014-004LACOSAMIDE200MGTABLET / ORALAB2024-04-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218014-001LACOSAMIDE50MGTABLET / ORALAB2024-04-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218014-002LACOSAMIDE100MGTABLET / ORALAB2024-04-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218014-003LACOSAMIDE150MGTABLET / ORALAB2024-04-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218014-004LACOSAMIDE200MGTABLET / ORALAB2024-04-025bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218014-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A218014-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A218014-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A218014-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A218014-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218014-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218014-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218014-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218014-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218014-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218014-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218014-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218014-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218014-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218014-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218014-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218014-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218014-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218014-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218014-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218014-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218014-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218014-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218014-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218014-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218014-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218014-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218014-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218014-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218014-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218014-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218014-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218014-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218014-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218014-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218014-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218014-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218014-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218014-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218014-004AB15bbf6a4d5a75…

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
IngredientStrength
LACOSAMIDE200 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
5c03b90e-6985-4005-b6c5-44626d0600d7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85742-011-07Lacosamide6 in 1 CARTONTABLET, FILM COATED61
85742-011-07Lacosamide10 in 1 BLISTER PACKTABLET, FILM COATED101
85742-011-08Lacosamide60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LacosamideLACOSAMIDEKanchan Healthcare Inc5c03b90e-6985-4005-b6c5-44626d0600d72025-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218014
application number: ANDA218014
ndc (product): 85742-011
LacosamideLACOSAMIDEMarlex Pharmaceuticals, Inc0a273024-c2d2-4fae-90c3-b2f38a323f242024-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218014
application number: ANDA218014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN5c03b90e-6985-4005-b6c5-44626d0600d71
809992lacosamide 150 MG Oral TabletPSN5c03b90e-6985-4005-b6c5-44626d0600d71
809996lacosamide 200 MG Oral TabletPSN5c03b90e-6985-4005-b6c5-44626d0600d71
810000lacosamide 50 MG Oral TabletPSN5c03b90e-6985-4005-b6c5-44626d0600d71
809987lacosamide 100 MG Oral TabletSCD5c03b90e-6985-4005-b6c5-44626d0600d71
809992lacosamide 150 MG Oral TabletSCD5c03b90e-6985-4005-b6c5-44626d0600d71
809996lacosamide 200 MG Oral TabletSCD5c03b90e-6985-4005-b6c5-44626d0600d71
810000lacosamide 50 MG Oral TabletSCD5c03b90e-6985-4005-b6c5-44626d0600d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85742-011-07857420011076 BLISTER PACK in 1 CARTON (85742-011-07) / 10 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2025-10-23NoNoCurrent
85742-011-088574200110860 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85742-011-08) 2025-10-23NoNoCurrent