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Medicine

Levetiracetam 100 mg/mL oral solution

Available on requestPrescription onlyUS FDAGeneric name

Levetiracetam 100 mg/mL oral solution is a generic prescription medicine for oral use, made by 22 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

Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…

Key facts

Active ingredient (INN)
Levetiracetam
Brand
Sold under the generic name
Strength
100 mg/mL
Dosage form
Oral solution
Route
Oral
Packs
500 mL, 473 mL, 40 cup and 48 more
Manufacturers
Sun Pharmaceutical IndustriesIndiaAurobindo PharmaIndiaNatco PharmaIndiaCamber PharmaceuticalsIndiaNovadoz PharmaceuticalsIndiaPAI PharmaMajor PharmaceuticalsPatrin PharmaQuagen PharmaceuticalsAmneal Pharmaceuticals22 labelers on the register
Origin register
US FDA, United States
Storage
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
Not recorded as controlled
ATC code
N03AX14 Levetiracetam
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
15 January 2009
Identifiers
RxCUI 403884, 311288, 311289 +2DailyMed set ID ba18ead0-69d7-453a-badc-cd6ad376d18e, bb6e1c75-66eb-4d18-af70-9b51fb67c4d6, 9dca1330-52ca-47a4-a134-ec55c9d5786d +23NDC 72162-2639, 72162-2667, 0121-0799 +26Application ANDA214757, ANDA090079, ANDA201157 +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

A sample of 40 packs from 22 labelers. The register lists 51 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
500 mL in 1 bottle, plastic65862-250-05Aurobindo PharmaIndia15 January 2009
473 mL in 1 bottle, plastic65862-250-47Aurobindo PharmaIndia15 January 2009
473 mL in 1 bottle31722-574-47Camber PharmaceuticalsIndia11 June 2015
40 cup, unit-dose in 1 box, unit-dose / 5 mL in 1 cup, unit-dose69339-157-17Natco PharmaIndia31 January 2021
100 cup, unit-dose in 1 box, unit-dose / 5 mL in 1 cup, unit-dose69339-157-19Natco PharmaIndia31 January 2021
473 mL in 1 bottle, plastic72205-037-72Novadoz PharmaceuticalsIndia18 July 2022
3785 mL in 1 bottle51672-4136-0Sun Pharmaceutical IndustriesIndia10 February 2009
100 mL in 1 bottle51672-4136-7Sun Pharmaceutical IndustriesIndia10 February 2009
473 mL in 1 bottle51672-4136-9Sun Pharmaceutical IndustriesIndia10 February 2009
473 mL in 1 bottle0121-0799-16PAI Pharma4 June 2015
2 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose0121-1598-20PAI Pharma10 October 2022
4 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose0121-1598-40PAI Pharma4 June 2015
4 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose0121-2397-40PAI Pharma4 June 2015
4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose0121-4799-40PAI Pharma4 June 2015
5 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose0121-4799-50PAI Pharma28 May 2020
473 mL in 1 bottle, plastic0472-0235-16Actavis Pharma15 January 2009
118 mL in 1 bottle65162-685-86Amneal Pharmaceuticals27 October 2009
473 mL in 1 bottle65162-685-90Amneal Pharmaceuticals27 October 2009
473 mL in 1 bottle69452-412-88Bionpharma18 July 2024
2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup68999-548-24Chartwell Governmental & Specialty RX29 October 2025
473 mL in 1 bottle62135-548-47Chartwell RX8 June 2022
473 mL in 1 bottle53041-660-06Guardian Drug2 December 2025
5 mL in 1 cup, unit-dose39328-511-05Patrin Pharma31 January 2024
3 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose39328-511-30Patrin Pharma31 January 2024
4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose39328-511-40Patrin Pharma31 January 2024
5 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose39328-511-50Patrin Pharma31 January 2024
10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose70752-203-02Quagen Pharmaceuticals1 February 2025
473 mL in 1 bottle70752-203-12Quagen Pharmaceuticals1 February 2025
10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose70752-203-16Quagen Pharmaceuticals1 February 2025
10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose70752-203-27Quagen Pharmaceuticals1 February 2025
473 mL in 1 bottle, plastic72162-2639-2Bryant Ranch Prepack6 May 2026
473 mL in 1 bottle72162-2667-2Bryant Ranch Prepack24 June 2026
5 cup, unit-dose in 1 bag / 5 mL in 1 cup, unit-dose55154-4316-5Cardinal Health1 August 2023
5 cup, unit-dose in 1 bag / 5 mL in 1 cup, unit-dose55154-5782-5Cardinal Health4 June 2015
5 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose0904-7265-92Major Pharmaceuticals21 November 2022
3 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose0904-7265-93Major Pharmaceuticals21 November 2022
4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose0904-7265-94Major Pharmaceuticals21 November 2022
473 mL in 1 bottle, plastic0904-7420-16Major Pharmaceuticals5 January 2024
10 cup, unit-dose in 1 box / 7.5 mL in 1 cup, unit-dose70518-3803-0Remedyrepack24 July 2023
10 cup, unit-dose in 1 box / 5 mL in 1 cup, unit-dose70518-3803-2Remedyrepack24 July 2023

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 30 November 1999Drugs@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 Levetiracetam 100 mg/mL oral solution.

Compare 1

Other strengths and forms of Levetiracetam

Clinical summary

Levetiracetam is a prescription medicine indicated for the treatment of partial-onset seizures in patients 1 month of age and older, among other approved uses. MedsAcross supplies Levetiracetam 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 Levetiracetam

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

Data sources

Need Levetiracetam 100 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.