Lacosamide

Product NDC
10135-799
11-digit product format
101350799
Labeler code
10135
Product ID
10135-799_67afbd17-4406-4e18-a302-c0a5829ec903
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc
Application
ANDA218014
Marketing category
ANDA
Marketing start
2025-05-23
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-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 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218014-001LACOSAMIDE50MGTABLET / 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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218014-001LACOSAMIDE50MGTABLET / ORALAB2024-04-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218014-002LACOSAMIDE100MGTABLET / ORALAB2024-04-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218014-003LACOSAMIDE150MGTABLET / ORALAB2024-04-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218014-004LACOSAMIDE200MGTABLET / ORALAB2024-04-02d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218014-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218014-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218014-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218014-004AB1d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACOSAMIDE50 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
0a273024-c2d2-4fae-90c3-b2f38a323f24Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
10135-799-60Lacosamide60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
10135-799-86Lacosamide6 in 1 CARTONTABLET, FILM COATED62
10135-799-86Lacosamide10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-799-60EA - Each10135-7993335ac08-7dc7-4cdb-ba5b-a42fff92dffb12025-12-16

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
LacosamideLACOSAMIDEMarlex Pharmaceuticals, Inc0a273024-c2d2-4fae-90c3-b2f38a323f242024-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218014
application number: ANDA218014
ndc (product): 10135-799

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN0a273024-c2d2-4fae-90c3-b2f38a323f242
809992lacosamide 150 MG Oral TabletPSN0a273024-c2d2-4fae-90c3-b2f38a323f242
809996lacosamide 200 MG Oral TabletPSN0a273024-c2d2-4fae-90c3-b2f38a323f242
810000lacosamide 50 MG Oral TabletPSN0a273024-c2d2-4fae-90c3-b2f38a323f242
809987lacosamide 100 MG Oral TabletSCD0a273024-c2d2-4fae-90c3-b2f38a323f242
809992lacosamide 150 MG Oral TabletSCD0a273024-c2d2-4fae-90c3-b2f38a323f242
809996lacosamide 200 MG Oral TabletSCD0a273024-c2d2-4fae-90c3-b2f38a323f242
810000lacosamide 50 MG Oral TabletSCD0a273024-c2d2-4fae-90c3-b2f38a323f242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10135-799-601013507996060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-799-60) 2025-07-01NoNoCurrent
10135-799-86101350799866 BLISTER PACK in 1 CARTON (10135-799-86) / 10 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2025-07-01NoNoCurrent