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Medicine

Lacosamide 10 mg/mL oral solution

Lacosamide · Oral
Available on requestPrescription onlyUS FDAControlled, schedule CVGeneric name

Lacosamide 10 mg/mL oral solution is a generic prescription medicine for oral use, made by 20 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Do not freeze lacosamide oral solution. Store at 20° to 25°C (68° to 77°F)…

Key facts

Active ingredient (INN)
Lacosamide
Brand
Sold under the generic name
Strength
10 mg/mL
Dosage form
Oral solution
Route
Oral
Packs
200 mL, 465 mL, 1 bottle and 43 more
Manufacturers
Novadoz PharmaceuticalsIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaGlenmark PharmaceuticalsIndiaPAI PharmaKesin PharmaChartwell RXChartwell Governmental & Specialty RXKanchan Healthcare20 labelers on the register
Origin register
US FDA, United States
Storage
Do not freeze lacosamide oral solution. Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Schedule CV
ATC code
N03AX18 Lacosamide
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
20 May 2022
Identifiers
RxCUI 993856DailyMed set ID 75de00d8-d2e7-4025-be4e-f49299068e7e, 458e80da-8fc1-4715-9b4b-bc4f388f933f, ba4e2e28-7dc3-47b3-9c2c-34e0b1f39fb8 +18NDC 0121-2024, 68462-940, 71921-411 +23Application ANDA216151, ANDA215379, ANDA220386 +6

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

A sample of 40 packs from 20 labelers. The register lists 46 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
200 mL in 1 bottle67877-732-95Ascend LaboratoriesIndia20 May 2022
465 mL in 1 bottle67877-732-97Ascend LaboratoriesIndia20 May 2022
200 mL in 1 bottle, plastic59651-016-02Aurobindo PharmaIndia24 January 2024
465 mL in 1 bottle, plastic59651-016-46Aurobindo PharmaIndia24 January 2024
1 bottle in 1 carton / 200 mL in 1 bottle31722-627-26Camber PharmaceuticalsIndia31 May 2022
1 bottle in 1 carton / 465 mL in 1 bottle31722-627-46Camber PharmaceuticalsIndia31 May 2022
200 mL in 1 bottle, plastic68462-940-86Glenmark PharmaceuticalsIndia30 September 2024
1 tray in 1 box / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose72205-034-50Novadoz PharmaceuticalsIndia12 December 2024
200 mL in 1 bottle, plastic72205-034-74Novadoz PharmaceuticalsIndia29 December 2023
465 mL in 1 bottle, plastic72205-034-75Novadoz PharmaceuticalsIndia29 December 2023
1 tray in 1 box / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose72205-034-91Novadoz PharmaceuticalsIndia12 December 2024
1 tray in 1 box / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose72205-034-93Novadoz PharmaceuticalsIndia12 December 2024
1 tray in 1 box / 10 cup, unit-dose in 1 tray / 20 mL in 1 cup, unit-dose72205-034-94Novadoz PharmaceuticalsIndia12 December 2024
3 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose0121-1012-94PAI Pharma2 November 2026
1 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose0121-1012-95PAI Pharma28 April 2023
3 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose0121-2024-94PAI Pharma2 November 2026
1 tray in 1 tray / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose0121-2024-95PAI Pharma28 April 2023
1 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose0121-3036-95PAI Pharma30 June 2023
1 tray in 1 case / 10 cup, unit-dose in 1 tray / 20 mL in 1 cup, unit-dose0121-4048-95PAI Pharma26 August 2022
200 mL in 1 bottle, plastic82983-427-31Ajenat Pharmaceuticals14 July 2025
200 mL in 1 bottle, plastic70954-488-10ANI Pharmaceuticals26 August 2022
2 tray in 1 box / 10 cup in 1 tray / 10 mL in 1 cup68999-885-23Chartwell Governmental & Specialty RX14 January 2026
2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup68999-885-24Chartwell Governmental & Specialty RX14 January 2026
200 mL in 1 bottle62135-885-22Chartwell RX27 November 2024
2 tray in 1 box / 10 cup in 1 tray / 10 mL in 1 cup62135-885-23Chartwell RX10 February 2025
2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup62135-885-24Chartwell RX10 February 2025
1 bottle in 1 carton / 200 mL in 1 bottle71921-411-71Florida Pharmaceutical Products30 January 2026
200 mL in 1 bottle, plastic85742-014-13Kanchan Healthcare25 July 2023
465 mL in 1 bottle, plastic85742-014-14Kanchan Healthcare25 July 2023
200 mL in 1 bottle, plastic69315-318-20Leading Pharma25 July 2023
465 mL in 1 bottle, plastic69315-318-46Leading Pharma25 July 2023
10 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose81033-427-14Kesin Pharmaceutical5 August 2025
10 cup, unit-dose in 1 carton / 10 mL in 1 cup, unit-dose81033-427-16Kesin Pharmaceutical5 August 2025
10 cup, unit-dose in 1 carton / 15 mL in 1 cup, unit-dose81033-427-17Kesin Pharmaceutical5 August 2025
10 cup, unit-dose in 1 carton / 20 mL in 1 cup, unit-dose81033-427-18Kesin Pharmaceutical5 August 2025
200 mL in 1 bottle, plastic81033-428-02Kesin Pharma14 July 2025
1 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose0904-7463-68Major Pharmaceuticals28 April 2023
1 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose0904-7464-64Major Pharmaceuticals26 June 2024
3 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose68094-076-62Precision Dose22 September 2025
3 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose68094-176-62Precision Dose22 September 2025

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 28 October 2008Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Lacosamide 10 mg/mL oral solution.

Compare 1

Other strengths and forms of Lacosamide

Clinical summary

Lacosamide is a prescription medicine indicated for treatment of partial-onset seizures in patients 1 month of age and older, among other approved uses. It is available as tablets, oral solution and injection for intravenous use. MedsAcross supplies Lacosamide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Lacosamide

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Lacosamide 10 mg/mL oral solution for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.