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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022253 | UCB INC | 2008-10-28 | 4 |
| NDA 022254 | UCB INC | 2008-10-28 | 1 |
| NDA 022255 | UCB INC | 2010-04-20 | 1 |
| ANDA 204921 | MSN LABS PVT LTD | 2022-03-17 | 12 |
| ANDA 204974 | ALEMBIC | 2022-03-17 | 11 |
| ANDA 204787 | HETERO LABS LTD V | 2022-03-17 | 9 |
| ANDA 205031 | SUN PHARM | 2022-03-17 | 4 |
| ANDA 208308 | REGCON HOLDINGS | 2022-03-17 | 16 |
| ANDA 204857 | AMNEAL PHARMS | 2022-03-17 | 4 |
| ANDA 205006 | GLENMARK PHARMS LTD | 2022-03-17 | 4 |
| ANDA 205237 | SCIEGEN PHARMS | 2022-03-17 | 13 |
| ANDA 214695 | ALKEM LABS LTD | 2022-03-31 | 14 |
| ANDA 214301 | REGCON HOLDINGS | 2022-04-07 | 2 |
| ANDA 214677 | FRESENIUS KABI USA | 2022-05-03 | 1 |
| ANDA 214672 | ALKEM LABS LTD | 2022-05-19 | 1 |
| ANDA 209301 | HETERO LABS LTD III | 2022-05-31 | 1 |
| ANDA 209465 | ZYDUS PHARMS | 2022-06-29 | 3 |
| ANDA 216151 | NOVITIUM PHARMA | 2022-08-26 | 7 |
| ANDA 216335 | ASPIRO | 2022-09-14 | 3 |
| ANDA 215628 | GLAND | 2022-09-19 | 3 |
| ANDA 204994 | AUROBINDO PHARMA LTD | 2023-01-05 | 4 |
| ANDA 216461 | KANCHAN HLTHCARE | 2023-02-06 | 4 |
| ANDA 215979 | MSN | 2023-02-09 | 1 |
| NDA 216185 | AUCTA | 2023-05-04 | 3 |
| ANDA 215379 | MSN | 2023-12-22 | 3 |
| ANDA 209224 | AUROBINDO PHARMA LTD | 2024-01-24 | 3 |
| ANDA 217311 | HAINAN POLY | 2024-02-13 | 1 |
| ANDA 217718 | DR REDDYS | 2024-03-25 | 1 |
| ANDA 218014 | KANCHAN HLTHCARE | 2024-04-02 | 8 |
| ANDA 215154 | CHARTWELL RX | 2024-05-15 | 2 |
| ANDA 208466 | MACLEODS PHARMS | 2024-05-24 | 4 |
| ANDA 213109 | UNICHEM | 2024-09-04 | 4 |
| ANDA 214960 | SOMERSET THERAPS LLC | 2024-10-09 | 1 |
| ANDA 218464 | ACELLA | 2024-11-14 | 1 |
| ANDA 218706 | WESTMINSTER PHARMS | 2025-05-23 | 1 |
| ANDA 219699 | AJENAT PHARMS | 2025-06-26 | 4 |
| ANDA 220268 | GLENMARK PHARMS | 2026-01-21 | 2 |
| ANDA 220386 | REGCON HOLDINGS | 2026-01-29 | 1 |
Official labeling on DailyMed
- LACOSAMIDE ORAL SOLUTION (LACOSAMIDE) SOLUTION [AVKARE] · version 1 · 2026-09-10
- LACOSAMIDE SOLUTION [NOVADOZ PHARMACEUTICALS LLC] · version 3 · 2026-08-24
- LACOSAMIDE SOLUTION [GLENMARK PHARMACEUTICALS LIMITED] · version 3 · 2026-08-20
- LACOSAMIDE TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC] · version 4 · 2026-08-17
- LACOSAMIDE INJECTION [FOSUN PHARMA USA] · version 7 · 2026-08-17
- LACOSAMIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-07-23
- LACOSAMIDE INJECTION [GLAND PHARMA LIMITED] · version 11 · 2026-07-15
- LACOSAMIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 7 · 2026-07-08
- LACOSAMIDE SOLUTION [AUROBINDO PHARMA LIMITED] · version 4 · 2026-07-02
- LACOSAMIDE SOLUTION [NORTHSTAR RX LLC] · version 3 · 2026-06-30
- LACOSAMIDE (LACOSAMIDE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · version 7 · 2026-06-23
- LACOSAMIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 5 · 2026-06-15
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.