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Active ingredient

Lacosamide

162 finished FDA listings contain Lacosamide as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
LACOSAMIDE
Dosage forms
Capsule, Extended Release, Injection, Injection, Solution, Solution, Tablet, Tablet, Film Coated
Routes
Intravenous, Oral
Manufacturers / labelers
58
Strengths listed
10 mg/ml · 100 mg/1 · 100 mg/10ml · 150 mg/1 · 150 mg/15ml · 200 mg/1 · 200 mg/20ml · 50 mg/1 · 50 mg/5ml
Brand names in FDA listings
Lacosamide Oral Solution, Motpoly Xr, Vimpat

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 623400

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 022253UCB INC2008-10-284
NDA 022254UCB INC2008-10-281
NDA 022255UCB INC2010-04-201
ANDA 204921MSN LABS PVT LTD2022-03-1712
ANDA 204974ALEMBIC2022-03-1711
ANDA 204787HETERO LABS LTD V2022-03-179
ANDA 205031SUN PHARM2022-03-174
ANDA 208308REGCON HOLDINGS2022-03-1716
ANDA 204857AMNEAL PHARMS2022-03-174
ANDA 205006GLENMARK PHARMS LTD2022-03-174
ANDA 205237SCIEGEN PHARMS2022-03-1713
ANDA 214695ALKEM LABS LTD2022-03-3114
ANDA 214301REGCON HOLDINGS2022-04-072
ANDA 214677FRESENIUS KABI USA2022-05-031
ANDA 214672ALKEM LABS LTD2022-05-191
ANDA 209301HETERO LABS LTD III2022-05-311
ANDA 209465ZYDUS PHARMS2022-06-293
ANDA 216151NOVITIUM PHARMA2022-08-267
ANDA 216335ASPIRO2022-09-143
ANDA 215628GLAND2022-09-193
ANDA 204994AUROBINDO PHARMA LTD2023-01-054
ANDA 216461KANCHAN HLTHCARE2023-02-064
ANDA 215979MSN2023-02-091
NDA 216185AUCTA2023-05-043
ANDA 215379MSN2023-12-223
ANDA 209224AUROBINDO PHARMA LTD2024-01-243
ANDA 217311HAINAN POLY2024-02-131
ANDA 217718DR REDDYS2024-03-251
ANDA 218014KANCHAN HLTHCARE2024-04-028
ANDA 215154CHARTWELL RX2024-05-152
ANDA 208466MACLEODS PHARMS2024-05-244
ANDA 213109UNICHEM2024-09-044
ANDA 214960SOMERSET THERAPS LLC2024-10-091
ANDA 218464ACELLA2024-11-141
ANDA 218706WESTMINSTER PHARMS2025-05-231
ANDA 219699AJENAT PHARMS2025-06-264
ANDA 220268GLENMARK PHARMS2026-01-212
ANDA 220386REGCON HOLDINGS2026-01-291

Official labeling on DailyMed

Showing the 12 most recent of 70 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.