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Medicine

Levetiracetam 500 mg/5 mL injection

Levetiracetam · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Levetiracetam 500 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 16 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 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).

Key facts

Active ingredient (INN)
Levetiracetam
Brand
Sold under the generic name
Strength
500 mg/5 mL
Dosage form
Injection
Route
Intravenous
Packs
10 vials of 5 mL, 25 vials of 5 mL, 5 vials of 5 mL and 26 more
Manufacturers
Micro LabsIndiaNovadoz PharmaceuticalsIndiaEugiaIndiaHikma PharmaceuticalsMethod PharmaceuticalsArmas PharmaceuticalsBaxter HealthcareBryant Ranch PrepackFresenius KabiHospira
Origin register
US FDA, United States
Storage
Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F 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
5 August 2011
Identifiers
RxCUI 647121DailyMed set ID 484e8d8f-be40-46f8-a509-d1bbdbbd2981, cc41696c-9cf0-4410-bacc-09132ee805ce, 7be45c40-8d75-4c40-97a4-95067129bc2a +16NDC 72205-120, 63323-400, 72485-106 +15Application ANDA215980, ANDA090876, ANDA211954 +8

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, single-dose in 1 carton / 5 mL in 1 vial, single-dose55150-177-05EugiaIndia1 February 2016
25 vial in 1 carton / 5 mL in 1 vial42571-331-38Micro LabsIndia3 August 2026
10 vial in 1 carton / 5 mL in 1 vial42571-331-92Micro LabsIndia4 October 2019
10 vial in 1 carton / 5 mL in 1 vial72205-120-07Novadoz PharmaceuticalsIndia9 February 2023
25 vial in 1 carton / 5 mL in 1 vial72205-120-25Novadoz PharmaceuticalsIndia9 February 2023
10 vial, single-use in 1 tray / 5 mL in 1 vial, single-use63323-400-05Fresenius Kabi13 August 2015
10 vial, single-use in 1 tray / 5 mL in 1 vial, single-use63323-400-44Fresenius Kabi13 August 2015
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose0143-9574-10Hikma Pharmaceuticals1 June 2015
25 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose0143-9574-25Hikma Pharmaceuticals1 June 2015
10 vial, glass in 1 box / 5 mL in 1 vial, glass0143-9673-10Hikma Pharmaceuticals13 October 2011
25 vial, glass in 1 carton / 5 mL in 1 vial, glass0143-9673-25Hikma Pharmaceuticals13 October 2011
25 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose0409-1886-02Hospira2 November 2012
25 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose0409-2011-25Hospira1 November 2021
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose72485-106-10Armas Pharmaceuticals14 January 2021
25 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose72485-106-25Armas Pharmaceuticals16 March 2023
10 vial in 1 carton / 5 mL in 1 vial85957-037-02Aryeh Pharma10 April 2026
5 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose36000-265-05Baxter Healthcare6 August 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose36000-265-10Baxter Healthcare6 August 2026
1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose58657-860-01Method Pharmaceuticals15 December 2025
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose58657-860-10Method Pharmaceuticals15 December 2025
25 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose58657-860-25Method Pharmaceuticals15 December 2025
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose67457-790-05Mylan Institutional24 July 2017
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose43547-454-10Solco Healthcare11 April 2022
5 mL in 1 vial39822-4000-1XGen Pharmaceuticals DJB5 August 2011
10 vial in 1 carton / 5 mL in 1 vial72162-2638-2Bryant Ranch Prepack6 May 2026
25 vial in 1 carton / 5 mL in 1 vial72162-2638-4Bryant Ranch Prepack6 May 2026
25 vial in 1 carton / 5 mL in 1 vial72572-360-25Civica1 December 2022
10 vial, single-use in 1 carton / 5 mL in 1 vial, single-use68094-313-10Precision Dose10 October 2024
25 vial, single-use in 1 carton / 5 mL in 1 vial, single-use68094-313-25Precision Dose10 October 2024

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 500 mg/5 mL injection.

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 500 mg/5 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.