Home DailyMed 0ae4e2d1-305d-4045-95da-cfe7c2d8b435 LACOSAMIDE film coated tablet, for oral use, CV Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer MSN LABORATORIES PRIVATE LIMITED
Effective date 2022-04-21
Label type Human Prescription Drug Label
Version 2
Source full-release
Hydrated at 2026-05-31 20:41:09 Label at a glance# Product lacosamide
Active ingredient LACOSAMIDE
Label structure 1 sections
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 809987 lacosamide 100 MG Oral Tablet PSN 2 809992 lacosamide 150 MG Oral Tablet PSN 2 809996 lacosamide 200 MG Oral Tablet PSN 2 810000 lacosamide 50 MG Oral Tablet PSN 2 809987 lacosamide 100 MG Oral Tablet SCD 2 809992 lacosamide 150 MG Oral Tablet SCD 2 809996 lacosamide 200 MG Oral Tablet SCD 2 810000 lacosamide 50 MG Oral Tablet SCD 2
DailyMed Pharmacologic Classes# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69539-025-05 lacosamide 500 in 1 BOTTLE TABLET, FILM COATED 500 2 69539-025-60 lacosamide 60 in 1 BOTTLE TABLET, FILM COATED 60 2 69539-026-05 lacosamide 500 in 1 BOTTLE TABLET, FILM COATED 500 2 69539-026-60 lacosamide 60 in 1 BOTTLE TABLET, FILM COATED 60 2 69539-027-05 lacosamide 500 in 1 BOTTLE TABLET, FILM COATED 500 2 69539-027-60 lacosamide 60 in 1 BOTTLE TABLET, FILM COATED 60 2 69539-028-05 lacosamide 500 in 1 BOTTLE TABLET, FILM COATED 500 2 69539-028-60 lacosamide 60 in 1 BOTTLE TABLET, FILM COATED 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69539-025 LACOSAMIDE TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED] 2 Current NDC, Legacy NDC, 2 package rows 20220422_0ae4e2d1-305d-4045-95da-cfe7c2d8b435.zip 69539-026 LACOSAMIDE TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED] 2 Current NDC, Legacy NDC, 2 package rows 20220422_0ae4e2d1-305d-4045-95da-cfe7c2d8b435.zip 69539-027 LACOSAMIDE TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED] 2 Current NDC, Legacy NDC, 2 package rows 20220422_0ae4e2d1-305d-4045-95da-cfe7c2d8b435.zip 69539-028 LACOSAMIDE TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED] 2 Current NDC, Legacy NDC, 2 package rows 20220422_0ae4e2d1-305d-4045-95da-cfe7c2d8b435.zip
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 16 matching rows.
lacosamide CROSPOVIDONE (120 .MU.M) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE FD&C BLUE NO. 2 FERRIC OXIDE RED FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) LECITHIN, SOYBEAN MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 2 · 56 matching rows.
Name, UNII, Kind table Name UNII Kind LACOSAMIDE 563KS2PQY5 ACTIB CROSPOVIDONE (120 .MU.M) 68401960MK IACT LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED 2165RE0K14 IACT MICROCRYSTALLINE CELLULOSE OP1R32D61U IACT FD&C BLUE NO. 2 L06K8R7DQK IACT FERRIC OXIDE RED 1K09F3G675 IACT FERROSOFERRIC OXIDE XM0M87F357 IACT HYDROXYPROPYL CELLULOSE (1600000 WAMW) RFW2ET671P IACT LECITHIN, SOYBEAN 1DI56QDM62 IACT MAGNESIUM STEARATE 70097M6I30 IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT POLYVINYL ALCOHOL, UNSPECIFIED 532B59J990 IACT SILICON DIOXIDE ETJ7Z6XBU4 IACT TALC 7SEV7J4R1U IACT TITANIUM DIOXIDE 15FIX9V2JP IACT LACOSAMIDE 563KS2PQY5 ACTIB CROSPOVIDONE (120 .MU.M) 68401960MK IACT LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED 2165RE0K14 IACT MICROCRYSTALLINE CELLULOSE OP1R32D61U IACT FERRIC OXIDE YELLOW EX438O2MRT IACT HYDROXYPROPYL CELLULOSE (1600000 WAMW) RFW2ET671P IACT LECITHIN, SOYBEAN 1DI56QDM62 IACT MAGNESIUM STEARATE 70097M6I30 IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT POLYVINYL ALCOHOL, UNSPECIFIED 532B59J990 IACT SILICON DIOXIDE ETJ7Z6XBU4 IACT TALC 7SEV7J4R1U IACT TITANIUM DIOXIDE 15FIX9V2JP IACT LACOSAMIDE 563KS2PQY5 ACTIB CROSPOVIDONE (120 .MU.M) 68401960MK IACT LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED 2165RE0K14 IACT MICROCRYSTALLINE CELLULOSE OP1R32D61U IACT FERRIC OXIDE YELLOW EX438O2MRT IACT FERRIC OXIDE RED 1K09F3G675 IACT FERROSOFERRIC OXIDE XM0M87F357 IACT HYDROXYPROPYL CELLULOSE (1600000 WAMW) RFW2ET671P IACT LECITHIN, SOYBEAN 1DI56QDM62 IACT MAGNESIUM STEARATE 70097M6I30 IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT POLYVINYL ALCOHOL, UNSPECIFIED 532B59J990 IACT
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204921-001 LACOSAMIDE LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 A204921-002 LACOSAMIDE LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 A204921-003 LACOSAMIDE LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 A204921-004 LACOSAMIDE LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A204921-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204921-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204921-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204921-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204921-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204921-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204921-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204921-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204921-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204921-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204921-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204921-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204921-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204921-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204921-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204921-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204921-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204921-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204921-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204921-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204921-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204921-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204921-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204921-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204921-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204921-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204921-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204921-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204921-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204921-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204921-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204921-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204921-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204921-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204921-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204921-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204921-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204921-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204921-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204921-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 128 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
