Lacosamide

Product NDC
65162-924
11-digit product format
651620924
Labeler code
65162
Product ID
65162-924_4f62fcbd-17ca-4664-9215-da51ba027b22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204857
Marketing category
ANDA
Marketing start
2022-03-21
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65162-924DDiscontinued by firm2026-08-17
excluded packagepackage65162-92465162-924-06DDiscontinued by firm2026-08-17
excluded packagepackage65162-92465162-924-50DDiscontinued by firm2026-08-17

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
A204857-001LACOSAMIDELACOSAMIDE50MGTABLET / ORAL2022-03-17
A204857-002LACOSAMIDELACOSAMIDE100MGTABLET / ORAL2022-03-17
A204857-003LACOSAMIDELACOSAMIDE150MGTABLET / ORAL2022-03-17
A204857-004LACOSAMIDELACOSAMIDE200MGTABLET / ORAL2022-03-17

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 · 124 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-001LACOSAMIDE50MGTABLET / ORALAB2022-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-002LACOSAMIDE100MGTABLET / ORALAB2022-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-003LACOSAMIDE150MGTABLET / ORALAB2022-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-004LACOSAMIDE200MGTABLET / ORALAB2022-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204857-001LACOSAMIDE50MGTABLET / ORAL2022-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204857-002LACOSAMIDE100MGTABLET / ORAL2022-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204857-003LACOSAMIDE150MGTABLET / ORAL2022-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204857-004LACOSAMIDE200MGTABLET / ORAL2022-03-17d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204857-004AB15bbf6a4d5a75…
2024-10-29 15:01 UTC2024-10A204857-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204857-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204857-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204857-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204857-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204857-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204857-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204857-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204857-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204857-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204857-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204857-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204857-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204857-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204857-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204857-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204857-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204857-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204857-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204857-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204857-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204857-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204857-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204857-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204857-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204857-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204857-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204857-004AB15d02ea3f76ae…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204857-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204857-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204857-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204857-004AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204857-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A204857-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A204857-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A204857-004AB11c564ffb4f44…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-924-06EA - Each65162-924993dac21-3f41-4c33-8617-15515eb37f6412022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-924LACOSAMIDE TABLET [AMNEAL PHARMACEUTICALS LLC]32Legacy NDC20240215_70782d6e-9dd1-400c-bd3e-511cdb26e24a.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
LacosamideLACOSAMIDEAmneal Pharmaceuticals of New York LLC0e21389b-2f51-4975-aa21-fc5c9dd9f6dc2024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204857
application number: ANDA204857

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-924-066516209240660 TABLET in 1 BOTTLE (65162-924-06) 60 tablet2022-03-210000-00-00NoNoCurrent
65162-924-5065162092450500 TABLET in 1 BOTTLE (65162-924-50) 500 tablet2022-03-210000-00-00NoNoCurrent