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Medicine

Lacosamide 200 mg/20 mL injection

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

Lacosamide 200 mg/20 mL injection is a generic prescription medicine for intravenous use, made by 18 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 Injection, USP. Store at 20°C to 25°C (68°F to 77°F)…

Key facts

Active ingredient (INN)
Lacosamide
Brand
Sold under the generic name
Strength
200 mg/20 mL
Dosage form
Injection
Route
Intravenous
Packs
10 vials of 20 mL, 5 vials of 20 mL and 18 more
Manufacturers
Zydus LifesciencesIndiaCamber PharmaceuticalsIndiaAnthea PharmaIndiaDr. Reddy's LaboratoriesIndiaGland PharmaIndiaGlenmark PharmaceuticalsIndiaIndoco RemediesIndiaNovadoz PharmaceuticalsIndiaFosun PharmaFresenius Kabi
Origin register
US FDA, United States
Storage
Do not freeze Lacosamide Injection, USP. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F 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
17 March 2022
Identifiers
RxCUI 809974DailyMed set ID 08ac486a-4f61-4e9e-9683-d1a66a6c2a4d, e24d3c45-a559-4fca-a7be-74ce37a7066e, cd5ac33e-6ac5-772b-2ead-d66cbd5bd1b4 +17NDC 83090-012, 31722-203, 43598-087 +17Application ANDA217311, ANDA216335, ANDA217718 +9

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

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
10 vial in 1 carton / 20 mL in 1 vial70710-1359-6Zydus LifesciencesIndia29 June 2022
10 vial in 1 carton / 20 mL in 1 vial70710-1886-6Zydus LifesciencesIndia10 November 2022
10 vial in 1 carton / 20 mL in 1 vial70771-1682-6Zydus LifesciencesIndia29 June 2022
10 vial in 1 carton / 20 mL in 1 vial83854-002-10Anthea PharmaIndia21 January 2026
10 vial, glass in 1 carton / 20 mL in 1 vial, glass31722-203-31Camber PharmaceuticalsIndia14 September 2022
10 vial, glass in 1 carton / 20 mL in 1 vial, glass31722-203-33Camber PharmaceuticalsIndia14 September 2022
10 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose43598-087-58Dr. Reddy's LaboratoriesIndia22 April 2024
10 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose68083-480-10Gland PharmaIndia19 September 2022
10 vial in 1 carton / 20 mL in 1 vial68462-697-30Glenmark PharmaceuticalsIndia16 March 2026
10 vial, glass in 1 carton / 20 mL in 1 vial, glass14445-406-20Indoco RemediesIndia9 April 2022
10 vial in 1 carton / 20 mL in 1 vial72205-220-07Novadoz PharmaceuticalsIndia23 May 2023
5 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose72266-242-05Fosun Pharma15 November 2022
10 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose65219-204-20Fresenius Kabi25 July 2022
10 vial, glass in 1 carton / 20 mL in 1 vial, glass25021-791-20Sagent Pharmaceuticals17 March 2022
10 vial, glass in 1 carton / 20 mL in 1 vial, glass83090-012-10Sintetica15 March 2024
10 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose70069-471-10Somerset Therapeutics10 October 2024
10 vial, glass in 1 carton / 20 mL in 1 vial, glass13811-207-40Trigen Laboratories30 June 2025
10 vial, glass in 1 carton / 20 mL in 1 vial, glass69543-455-10Virtus Pharmaceuticals17 April 2023
10 vial, glass in 1 carton / 20 mL in 1 vial, glass72865-235-10XLCare Pharmaceuticals25 January 2023
10 vial, glass in 1 carton / 20 mL in 1 vial, glass72603-263-02NorthStar RxLLC15 July 2024
10 vial, glass in 1 carton / 20 mL in 1 vial, glass69367-352-10Westminster Pharmaceuticals23 May 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 200 mg/20 mL injection.

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 200 mg/20 mL injection 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.