Home NDC 27808-243 Lacosamide
Product NDC 27808-243
11-digit product format 278080243
Labeler code 27808
Product ID 27808-243_299cd2a3-f5a6-4e6e-8f26-84da23cff30c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lacosamide
Dosage form TABLET
Route ORAL
Labeler Tris Pharma Inc
Application ANDA208308
Marketing category ANDA
Marketing start 2022-03-19
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 42 .
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 A208308-001 LACOSAMIDE LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 A208308-002 LACOSAMIDE LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 A208308-003 LACOSAMIDE LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 A208308-004 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 · 124 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 2026-08-18 06:07:40 2026-07 A208308-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208308-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208308-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208308-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208308-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208308-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208308-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208308-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208308-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208308-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208308-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208308-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208308-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208308-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208308-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208308-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208308-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208308-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208308-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208308-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208308-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208308-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208308-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208308-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208308-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208308-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208308-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208308-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208308-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208308-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208308-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208308-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208308-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208308-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208308-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208308-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208308-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208308-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208308-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208308-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 124 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lacosamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACOSAMIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 563KS2PQY5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 809987 Internal RxNorm lookup 809992 Internal RxNorm lookup 809996 Internal RxNorm lookup 810000 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 27808-243-01 Lacosamide 60 in 1 BOTTLE TABLET 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27808-243 LACOSAMIDE TABLET [TRIS PHARMA INC] 6 Current NDC, Legacy NDC, 1 package rows 20230627_7f37f8b8-07d3-48c4-a0c4-7652b62a1ad9.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 27808-243-01 27808024301 60 TABLET in 1 BOTTLE (27808-243-01) 60 tablet 2022-03-19 0000-00-00 No No Current