Home NDC 65162-912 Lacosamide
Product NDC 65162-912
11-digit product format 651620912
Labeler code 65162
Product ID 65162-912_32fb4b27-d0ee-4fb9-9f4f-f3845999d299
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lacosamide
Dosage form SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals of New York, LLC
Application ANDA204839
Marketing category ANDA
Marketing start 2013-11-29
Marketing end 0000-00-00
Substance LACOSAMIDE
Active strength 10 mg/mL
Pharmacologic classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule CV
NDC exclude flag E
Listing certified through 2017-12-31
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 65162-912-68 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 65162-912-68 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 65162-912-68 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204839-001 LACOSAMIDE LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27
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.
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 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204839-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL 2024-03-27 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-912 LACOSAMIDE SOLUTION [AMNEAL PHARMACEUTICALS LLC] 43 Legacy NDC 20240331_a2c72461-3538-4a38-8994-e5fb1637c294.zip