Home NDC 65162-923-50 Lacosamide
Product NDC 65162-923
Requested package NDC 65162-923-50
11-digit product format 651620923
Labeler code 65162
Product ID 65162-923_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 50 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 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 A204857-001 LACOSAMIDE LACOSAMIDE 50MG TABLET / ORAL 2022-03-17 A204857-002 LACOSAMIDE LACOSAMIDE 100MG TABLET / ORAL 2022-03-17 A204857-003 LACOSAMIDE LACOSAMIDE 150MG TABLET / ORAL 2022-03-17 A204857-004 LACOSAMIDE LACOSAMIDE 200MG TABLET / ORAL 2022-03-17
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 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 A204857-001 LACOSAMIDE 50MG TABLET / ORAL 2022-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204857-002 LACOSAMIDE 100MG TABLET / ORAL 2022-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204857-003 LACOSAMIDE 150MG TABLET / ORAL 2022-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204857-004 LACOSAMIDE 200MG TABLET / ORAL 2022-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204857-001 LACOSAMIDE 50MG TABLET / ORAL 2022-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204857-002 LACOSAMIDE 100MG TABLET / ORAL 2022-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204857-003 LACOSAMIDE 150MG TABLET / ORAL 2022-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204857-004 LACOSAMIDE 200MG TABLET / ORAL 2022-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204857-001 LACOSAMIDE 50MG TABLET / ORAL 2022-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204857-002 LACOSAMIDE 100MG TABLET / ORAL 2022-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204857-003 LACOSAMIDE 150MG TABLET / ORAL 2022-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204857-004 LACOSAMIDE 200MG TABLET / ORAL 2022-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204857-001 LACOSAMIDE 50MG TABLET / ORAL 2022-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204857-002 LACOSAMIDE 100MG TABLET / ORAL 2022-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204857-003 LACOSAMIDE 150MG TABLET / ORAL 2022-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204857-004 LACOSAMIDE 200MG TABLET / ORAL 2022-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204857-001 LACOSAMIDE 50MG TABLET / ORAL 2022-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204857-002 LACOSAMIDE 100MG TABLET / ORAL 2022-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204857-003 LACOSAMIDE 150MG TABLET / ORAL 2022-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204857-004 LACOSAMIDE 200MG TABLET / ORAL 2022-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204857-001 LACOSAMIDE 50MG TABLET / ORAL 2022-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204857-002 LACOSAMIDE 100MG TABLET / ORAL 2022-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204857-003 LACOSAMIDE 150MG TABLET / ORAL 2022-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204857-004 LACOSAMIDE 200MG TABLET / ORAL 2022-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204857-001 LACOSAMIDE 50MG TABLET / ORAL 2022-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204857-002 LACOSAMIDE 100MG TABLET / ORAL 2022-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204857-003 LACOSAMIDE 150MG TABLET / ORAL 2022-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204857-004 LACOSAMIDE 200MG TABLET / ORAL 2022-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204857-001 LACOSAMIDE 50MG TABLET / ORAL 2022-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204857-002 LACOSAMIDE 100MG TABLET / ORAL 2022-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204857-003 LACOSAMIDE 150MG TABLET / ORAL 2022-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204857-004 LACOSAMIDE 200MG TABLET / ORAL 2022-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204857-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204857-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204857-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204857-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204857-001 LACOSAMIDE 50MG TABLET / ORAL 2022-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204857-002 LACOSAMIDE 100MG TABLET / ORAL 2022-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204857-003 LACOSAMIDE 150MG TABLET / ORAL 2022-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204857-004 LACOSAMIDE 200MG TABLET / ORAL 2022-03-17 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-923 LACOSAMIDE TABLET [AMNEAL PHARMACEUTICALS LLC] 32 Legacy NDC 20240215_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lacosamide LACOSAMIDE Amneal Pharmaceuticals of New York LLC 0e21389b-2f51-4975-aa21-fc5c9dd9f6dc 2024-05-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 204857 application number: ANDA204857
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65162-923-50 65162092350 500 TABLET in 1 BOTTLE (65162-923-50) 500 tablet 2022-03-21 0000-00-00 No No Current