LACOSAMIDE

Product NDC
51407-721
11-digit product format
514070721
Labeler code
51407
Product ID
51407-721_2cb56870-d40d-b6d2-e063-6394a90aa4c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACOSAMIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA204921
Marketing category
ANDA
Marketing start
2022-03-17
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 1.

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
A204921-001LACOSAMIDELACOSAMIDE50MGTABLET / ORALAB2022-03-17
A204921-002LACOSAMIDELACOSAMIDE100MGTABLET / ORALAB2022-03-17
A204921-003LACOSAMIDELACOSAMIDE150MGTABLET / ORALAB2022-03-17
A204921-004LACOSAMIDELACOSAMIDE200MGTABLET / ORALAB2022-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204921-001AB
A204921-002AB
A204921-003AB
A204921-004AB

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 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204921-001LACOSAMIDE50MGTABLET / ORALAB2022-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204921-002LACOSAMIDE100MGTABLET / ORALAB2022-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204921-003LACOSAMIDE150MGTABLET / ORALAB2022-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204921-004LACOSAMIDE200MGTABLET / ORALAB2022-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204921-001LACOSAMIDE50MGTABLET / ORALAB2022-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204921-002LACOSAMIDE100MGTABLET / ORALAB2022-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204921-003LACOSAMIDE150MGTABLET / ORALAB2022-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204921-004LACOSAMIDE200MGTABLET / ORALAB2022-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204921-001LACOSAMIDE50MGTABLET / ORALAB2022-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204921-002LACOSAMIDE100MGTABLET / ORALAB2022-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204921-003LACOSAMIDE150MGTABLET / ORALAB2022-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204921-004LACOSAMIDE200MGTABLET / ORALAB2022-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204921-001LACOSAMIDE50MGTABLET / ORALAB2022-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204921-002LACOSAMIDE100MGTABLET / ORALAB2022-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204921-003LACOSAMIDE150MGTABLET / ORALAB2022-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204921-004LACOSAMIDE200MGTABLET / ORALAB2022-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204921-001LACOSAMIDE50MGTABLET / ORALAB2022-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204921-002LACOSAMIDE100MGTABLET / ORALAB2022-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204921-003LACOSAMIDE150MGTABLET / ORALAB2022-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204921-004LACOSAMIDE200MGTABLET / ORALAB2022-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204921-001LACOSAMIDE50MGTABLET / ORALAB2022-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204921-002LACOSAMIDE100MGTABLET / ORALAB2022-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204921-003LACOSAMIDE150MGTABLET / ORALAB2022-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204921-004LACOSAMIDE200MGTABLET / ORALAB2022-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204921-001LACOSAMIDE50MGTABLET / ORALAB2022-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204921-002LACOSAMIDE100MGTABLET / ORALAB2022-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204921-003LACOSAMIDE150MGTABLET / ORALAB2022-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204921-004LACOSAMIDE200MGTABLET / ORALAB2022-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204921-001LACOSAMIDE50MGTABLET / ORALAB2022-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204921-002LACOSAMIDE100MGTABLET / ORALAB2022-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204921-003LACOSAMIDE150MGTABLET / ORALAB2022-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204921-004LACOSAMIDE200MGTABLET / ORALAB2022-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204921-001LACOSAMIDE50MGTABLET / ORALAB2022-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204921-002LACOSAMIDE100MGTABLET / ORALAB2022-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204921-003LACOSAMIDE150MGTABLET / ORALAB2022-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204921-004LACOSAMIDE200MGTABLET / ORALAB2022-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204921-001LACOSAMIDE50MGTABLET / ORALAB2022-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A204921-002LACOSAMIDE100MGTABLET / ORALAB2022-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A204921-003LACOSAMIDE150MGTABLET / ORALAB2022-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A204921-004LACOSAMIDE200MGTABLET / ORALAB2022-03-17d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204921-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204921-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204921-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204921-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204921-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204921-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204921-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204921-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204921-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204921-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204921-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204921-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204921-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204921-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204921-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204921-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204921-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204921-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204921-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204921-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204921-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204921-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204921-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204921-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204921-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204921-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204921-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204921-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204921-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204921-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204921-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204921-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204921-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204921-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204921-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204921-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204921-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204921-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204921-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204921-004AB1d06236e962d9…

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
f047077c-2ac7-30d0-e053-2995a90ae429Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-721-60LACOSAMIDE60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-721-60EA - Each51407-72109adc900-76e7-4f96-ae80-0b9c14fbbc5312023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-721LACOSAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]5Current NDC, Legacy NDC, 1 package rows20250130_f047077c-2ac7-30d0-e053-2995a90ae429.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LACOSAMIDELACOSAMIDEGolden State Medical Supply, Inc.f047077c-2ac7-30d0-e053-2995a90ae4292025-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204921
application number: ANDA204921
ndc (product): 51407-721
LACOSAMIDELACOSAMIDEBreckenridge Pharmaceutical, Inc.f7ea3ce6-4ca7-4405-a011-48e7d71360a52024-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204921
application number: ANDA204921
lacosamideLACOSAMIDEMSN LABORATORIES PRIVATE LIMITED0ae4e2d1-305d-4045-95da-cfe7c2d8b4352022-04-21Exact identifier
application applno (ANDA): 204921
application number: ANDA204921

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSNf047077c-2ac7-30d0-e053-2995a90ae4295
809992lacosamide 150 MG Oral TabletPSNf047077c-2ac7-30d0-e053-2995a90ae4295
809996lacosamide 200 MG Oral TabletPSNf047077c-2ac7-30d0-e053-2995a90ae4295
810000lacosamide 50 MG Oral TabletPSNf047077c-2ac7-30d0-e053-2995a90ae4295
809987lacosamide 100 MG Oral TabletSCDf047077c-2ac7-30d0-e053-2995a90ae4295
809992lacosamide 150 MG Oral TabletSCDf047077c-2ac7-30d0-e053-2995a90ae4295
809996lacosamide 200 MG Oral TabletSCDf047077c-2ac7-30d0-e053-2995a90ae4295
810000lacosamide 50 MG Oral TabletSCDf047077c-2ac7-30d0-e053-2995a90ae4295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-721-605140707216060 TABLET, FILM COATED in 1 BOTTLE (51407-721-60) 2022-12-190000-00-00NoNoCurrent