Lacosamide

Product NDC
65862-748
11-digit product format
658620748
Labeler code
65862
Product ID
65862-748_96c862f5-632a-4407-acbc-28d956779eeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204994
Marketing category
ANDA
Marketing start
2023-01-05
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 44.

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
A204994-001LACOSAMIDELACOSAMIDE50MGTABLET / ORALAB2023-01-05
A204994-002LACOSAMIDELACOSAMIDE100MGTABLET / ORALAB2023-01-05
A204994-003LACOSAMIDELACOSAMIDE150MGTABLET / ORALAB2023-01-05
A204994-004LACOSAMIDELACOSAMIDE200MGTABLET / ORALAB2023-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204994-001AB
A204994-002AB
A204994-003AB
A204994-004AB

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 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A204994-001LACOSAMIDE50MGTABLET / ORALAB2023-01-05c2088c7a36db…
2026-10-15 13:18:302026-09A204994-002LACOSAMIDE100MGTABLET / ORALAB2023-01-05c2088c7a36db…
2026-10-15 13:18:302026-09A204994-003LACOSAMIDE150MGTABLET / ORALAB2023-01-05c2088c7a36db…
2026-10-15 13:18:302026-09A204994-004LACOSAMIDE200MGTABLET / ORALAB2023-01-05c2088c7a36db…
2026-09-14 22:38:342026-08A204994-001LACOSAMIDE50MGTABLET / ORALAB2023-01-0584e616aacf4f…
2026-09-14 22:38:342026-08A204994-002LACOSAMIDE100MGTABLET / ORALAB2023-01-0584e616aacf4f…
2026-09-14 22:38:342026-08A204994-003LACOSAMIDE150MGTABLET / ORALAB2023-01-0584e616aacf4f…
2026-09-14 22:38:342026-08A204994-004LACOSAMIDE200MGTABLET / ORALAB2023-01-0584e616aacf4f…
2026-08-18 06:07:402026-07A204994-001LACOSAMIDE50MGTABLET / ORALAB2023-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A204994-002LACOSAMIDE100MGTABLET / ORALAB2023-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A204994-003LACOSAMIDE150MGTABLET / ORALAB2023-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A204994-004LACOSAMIDE200MGTABLET / ORALAB2023-01-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204994-001LACOSAMIDE50MGTABLET / ORALAB2023-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204994-002LACOSAMIDE100MGTABLET / ORALAB2023-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204994-003LACOSAMIDE150MGTABLET / ORALAB2023-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204994-004LACOSAMIDE200MGTABLET / ORALAB2023-01-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204994-001LACOSAMIDE50MGTABLET / ORALAB2023-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204994-002LACOSAMIDE100MGTABLET / ORALAB2023-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204994-003LACOSAMIDE150MGTABLET / ORALAB2023-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204994-004LACOSAMIDE200MGTABLET / ORALAB2023-01-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204994-001LACOSAMIDE50MGTABLET / ORALAB2023-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204994-002LACOSAMIDE100MGTABLET / ORALAB2023-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204994-003LACOSAMIDE150MGTABLET / ORALAB2023-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204994-004LACOSAMIDE200MGTABLET / ORALAB2023-01-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204994-001LACOSAMIDE50MGTABLET / ORALAB2023-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204994-002LACOSAMIDE100MGTABLET / ORALAB2023-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204994-003LACOSAMIDE150MGTABLET / ORALAB2023-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204994-004LACOSAMIDE200MGTABLET / ORALAB2023-01-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204994-001LACOSAMIDE50MGTABLET / ORALAB2023-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204994-002LACOSAMIDE100MGTABLET / ORALAB2023-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204994-003LACOSAMIDE150MGTABLET / ORALAB2023-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204994-004LACOSAMIDE200MGTABLET / ORALAB2023-01-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204994-001LACOSAMIDE50MGTABLET / ORALAB2023-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204994-002LACOSAMIDE100MGTABLET / ORALAB2023-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204994-003LACOSAMIDE150MGTABLET / ORALAB2023-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204994-004LACOSAMIDE200MGTABLET / ORALAB2023-01-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204994-001LACOSAMIDE50MGTABLET / ORALAB2023-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204994-002LACOSAMIDE100MGTABLET / ORALAB2023-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204994-003LACOSAMIDE150MGTABLET / ORALAB2023-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204994-004LACOSAMIDE200MGTABLET / ORALAB2023-01-052680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A204994-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A204994-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A204994-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A204994-004AB1c2088c7a36db…
2026-09-14 22:38:342026-08A204994-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A204994-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A204994-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A204994-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A204994-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204994-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204994-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204994-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204994-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204994-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204994-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204994-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204994-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204994-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204994-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204994-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204994-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204994-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204994-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204994-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204994-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204994-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204994-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204994-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204994-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204994-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204994-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204994-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204994-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204994-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204994-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204994-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204994-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204994-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204994-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204994-004AB12680178bc6a6…

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
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
6140b3f1-ff60-427c-91d7-15af99fd78f1Available 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
65862-748-03Lacosamide3 in 1 CARTONTABLET, FILM COATED36
65862-748-10Lacosamide10 in 1 BLISTER PACKTABLET, FILM COATED106
65862-748-60Lacosamide60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-748-60EA - Each65862-748cf8ca4e5-4716-4928-ab7b-858e69f50c1012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-748LACOSAMIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5Current NDC, 3 package rows20241019_6140b3f1-ff60-427c-91d7-15af99fd78f1.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
LacosamideLACOSAMIDEAurobindo Pharma Limited6140b3f1-ff60-427c-91d7-15af99fd78f12026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204994
application number: ANDA204994
ndc (product): 65862-748

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN6140b3f1-ff60-427c-91d7-15af99fd78f16
809992lacosamide 150 MG Oral TabletPSN6140b3f1-ff60-427c-91d7-15af99fd78f16
809996lacosamide 200 MG Oral TabletPSN6140b3f1-ff60-427c-91d7-15af99fd78f16
810000lacosamide 50 MG Oral TabletPSN6140b3f1-ff60-427c-91d7-15af99fd78f16
809987lacosamide 100 MG Oral TabletSCD6140b3f1-ff60-427c-91d7-15af99fd78f16
809992lacosamide 150 MG Oral TabletSCD6140b3f1-ff60-427c-91d7-15af99fd78f16
809996lacosamide 200 MG Oral TabletSCD6140b3f1-ff60-427c-91d7-15af99fd78f16
810000lacosamide 50 MG Oral TabletSCD6140b3f1-ff60-427c-91d7-15af99fd78f16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65862-748-03658620748033 BLISTER PACK in 1 CARTON (65862-748-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-748-10) 3 blister pack2023-01-05NoNoCurrent
65862-748-106586207481010 in 1 BLISTER PACKHistorical
65862-748-606586207486060 TABLET, FILM COATED in 1 BOTTLE (65862-748-60) 2023-01-05NoNoCurrent