Home NDC 70518-0257-0 Vimpat
Product NDC 70518-0257
Requested package NDC 70518-0257-0
11-digit product format 705180257
Labeler code 70518
Product ID 70518-0257_a3de63ee-3c38-1347-e053-2a95a90afe7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lacosamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA022253
Marketing category NDA
Marketing start 2017-02-23
Marketing end 0000-00-00
Substance LACOSAMIDE
Active strength 100 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule CV
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N022253-001 VIMPAT LACOSAMIDE 50MG TABLET / ORAL AB RLD 2008-10-28 N022253-002 VIMPAT LACOSAMIDE 100MG TABLET / ORAL AB RLD 2008-10-28 N022253-003 VIMPAT LACOSAMIDE 150MG TABLET / ORAL AB RLD 2008-10-28 N022253-004 VIMPAT LACOSAMIDE 200MG TABLET / ORAL AB RLD, RS 2008-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book exclusivity# Current exclusivity 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 5 · 172 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 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 128 observed states.
Observed Orange Book patent history# Patent history page 1 of 8 · 296 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-001 RE38551 2022-03-17 U-2140 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-001 RE38551 2022-03-17 U-1567 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-001 RE38551 2022-03-17 U-2999 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-001 RE38551 2022-03-17 U-2990 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-001 RE38551 2022-03-17 U-2989 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-002 RE38551 2022-03-17 U-1567 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-002 RE38551 2022-03-17 U-2999 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-002 RE38551 2022-03-17 U-2990 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-002 RE38551 2022-03-17 U-2989 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-002 RE38551 2022-03-17 U-2140 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-003 RE38551 2022-03-17 U-2140 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-003 RE38551 2022-03-17 U-2999 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-003 RE38551 2022-03-17 U-2989 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-003 RE38551 2022-03-17 U-2990 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-003 RE38551 2022-03-17 U-1567 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-004 RE38551 2022-03-17 U-2140 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-004 RE38551 2022-03-17 U-1567 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-004 RE38551 2022-03-17 U-2999 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-004 RE38551 2022-03-17 U-2989 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022253-004 RE38551 2022-03-17 U-2990 Drug substance, Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022253-001 RE38551 2022-03-17 U-2140 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-001 RE38551 2022-03-17 U-1567 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-001 RE38551 2022-03-17 U-2999 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-001 RE38551 2022-03-17 U-2990 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-001 RE38551 2022-03-17 U-2989 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-002 RE38551 2022-03-17 U-1567 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-002 RE38551 2022-03-17 U-2999 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-002 RE38551 2022-03-17 U-2990 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-002 RE38551 2022-03-17 U-2989 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-002 RE38551 2022-03-17 U-2140 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-003 RE38551 2022-03-17 U-2140 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-003 RE38551 2022-03-17 U-2999 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-003 RE38551 2022-03-17 U-2989 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-003 RE38551 2022-03-17 U-2990 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-003 RE38551 2022-03-17 U-1567 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-004 RE38551 2022-03-17 U-2140 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-004 RE38551 2022-03-17 U-1567 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-004 RE38551 2022-03-17 U-2999 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-004 RE38551 2022-03-17 U-2989 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022253-004 RE38551 2022-03-17 U-2990 Drug substance, Drug product 5d02ea3f76ae…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 276 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70518-0257-0 70518025700 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0257-0) 2017-02-23 0000-00-00 No No Current