Lacosamide

Product NDC
80425-0510
11-digit product format
804250510
Labeler code
80425
Product ID
80425-0510_325df1f8-167c-c07c-e063-6294a90a96fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA214695
Marketing category
ANDA
Marketing start
2025-04-09
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 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
A214695-001LACOSAMIDELACOSAMIDE50MGTABLET / ORALAB2022-03-31
A214695-002LACOSAMIDELACOSAMIDE100MGTABLET / ORALAB2022-03-31
A214695-003LACOSAMIDELACOSAMIDE150MGTABLET / ORALAB2022-03-31
A214695-004LACOSAMIDELACOSAMIDE200MGTABLET / ORALAB2022-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214695-001AB
A214695-002AB
A214695-003AB
A214695-004AB

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 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214695-001LACOSAMIDE50MGTABLET / ORALAB2022-03-3184e616aacf4f…
2026-09-14 22:38:342026-08A214695-002LACOSAMIDE100MGTABLET / ORALAB2022-03-3184e616aacf4f…
2026-09-14 22:38:342026-08A214695-003LACOSAMIDE150MGTABLET / ORALAB2022-03-3184e616aacf4f…
2026-09-14 22:38:342026-08A214695-004LACOSAMIDE200MGTABLET / ORALAB2022-03-3184e616aacf4f…
2026-08-18 06:07:402026-07A214695-001LACOSAMIDE50MGTABLET / ORALAB2022-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07A214695-002LACOSAMIDE100MGTABLET / ORALAB2022-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07A214695-003LACOSAMIDE150MGTABLET / ORALAB2022-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07A214695-004LACOSAMIDE200MGTABLET / ORALAB2022-03-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214695-001LACOSAMIDE50MGTABLET / ORALAB2022-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214695-002LACOSAMIDE100MGTABLET / ORALAB2022-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214695-003LACOSAMIDE150MGTABLET / ORALAB2022-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214695-004LACOSAMIDE200MGTABLET / ORALAB2022-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214695-001LACOSAMIDE50MGTABLET / ORALAB2022-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214695-002LACOSAMIDE100MGTABLET / ORALAB2022-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214695-003LACOSAMIDE150MGTABLET / ORALAB2022-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214695-004LACOSAMIDE200MGTABLET / ORALAB2022-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214695-001LACOSAMIDE50MGTABLET / ORALAB2022-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214695-002LACOSAMIDE100MGTABLET / ORALAB2022-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214695-003LACOSAMIDE150MGTABLET / ORALAB2022-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214695-004LACOSAMIDE200MGTABLET / ORALAB2022-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214695-001LACOSAMIDE50MGTABLET / ORALAB2022-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214695-002LACOSAMIDE100MGTABLET / ORALAB2022-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214695-003LACOSAMIDE150MGTABLET / ORALAB2022-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214695-004LACOSAMIDE200MGTABLET / ORALAB2022-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214695-001LACOSAMIDE50MGTABLET / ORALAB2022-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214695-002LACOSAMIDE100MGTABLET / ORALAB2022-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214695-003LACOSAMIDE150MGTABLET / ORALAB2022-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214695-004LACOSAMIDE200MGTABLET / ORALAB2022-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214695-001LACOSAMIDE50MGTABLET / ORALAB2022-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214695-002LACOSAMIDE100MGTABLET / ORALAB2022-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214695-003LACOSAMIDE150MGTABLET / ORALAB2022-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214695-004LACOSAMIDE200MGTABLET / ORALAB2022-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214695-001LACOSAMIDE50MGTABLET / ORALAB2022-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214695-002LACOSAMIDE100MGTABLET / ORALAB2022-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214695-003LACOSAMIDE150MGTABLET / ORALAB2022-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214695-004LACOSAMIDE200MGTABLET / ORALAB2022-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214695-001LACOSAMIDE50MGTABLET / ORALAB2022-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214695-002LACOSAMIDE100MGTABLET / ORALAB2022-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214695-003LACOSAMIDE150MGTABLET / ORALAB2022-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214695-004LACOSAMIDE200MGTABLET / ORALAB2022-03-315bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214695-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A214695-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A214695-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A214695-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A214695-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214695-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214695-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214695-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214695-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214695-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214695-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214695-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214695-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214695-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214695-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214695-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214695-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214695-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214695-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214695-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214695-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214695-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214695-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214695-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214695-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214695-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214695-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214695-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214695-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214695-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214695-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214695-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214695-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214695-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214695-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214695-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214695-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214695-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214695-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214695-004AB15bbf6a4d5a75…

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
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
325df1b7-4908-0c03-e063-6294a90ad844Available 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
80425-0510-1Lacosamide30 in 1 BOTTLETABLET, FILM COATED301
80425-0510-2Lacosamide60 in 1 BOTTLETABLET, FILM COATED601
80425-0510-3Lacosamide90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0510-1EA - Each80425-0510bca5104d-ff27-4102-9964-56578acbed1812025-05-14
80425-0510-2EA - Each80425-051091206874-fd7c-4a0a-b1f5-1ad2d20c4c9212025-05-14
80425-0510-3EA - Each80425-051010fbc861-e367-4650-8d8e-0c9f7da5f4d912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0510LACOSAMIDE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20250410_325df1b7-4908-0c03-e063-6294a90ad844.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LacosamideLACOSAMIDEMajor Pharmaceuticalsc83d2156-4dde-4316-98f1-b3dc751f3eac2026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214695
application number: ANDA214695
LacosamideLACOSAMIDEAmerican Health Packaging19060029-c158-4a37-9261-cfe3b2b5b1e32026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214695
application number: ANDA214695
LacosamideLACOSAMIDEAscend Laboratories, LLC9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de2025-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214695
application number: ANDA214695
LacosamideLACOSAMIDEAdvanced Rx of Tennessee, LLC325df1b7-4908-0c03-e063-6294a90ad8442025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214695
application number: ANDA214695
ndc (product): 80425-0510

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810000lacosamide 50 MG Oral TabletPSN325df1b7-4908-0c03-e063-6294a90ad8441
810000lacosamide 50 MG Oral TabletSCD325df1b7-4908-0c03-e063-6294a90ad8441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0510-18042505100130 TABLET, FILM COATED in 1 BOTTLE (80425-0510-1) 2025-04-09NoNoCurrent
80425-0510-28042505100260 TABLET, FILM COATED in 1 BOTTLE (80425-0510-2) 2025-04-09NoNoCurrent
80425-0510-38042505100390 TABLET, FILM COATED in 1 BOTTLE (80425-0510-3) 2025-04-09NoNoCurrent