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Medicine

Vigabatrin 500 mg tablet

Vigabatrin · Oral
Available on requestPrescription onlyUS FDAGeneric name

Vigabatrin 500 mg tablet is a generic prescription medicine for oral use, made by 7 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°C to 25°C (68°F to 77°F). See USP Controlled Room Temperature.

Key facts

Active ingredient (INN)
Vigabatrin
Brand
Sold under the generic name
Strength
500 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 1 bottle and 5 more
Manufacturers
Zydus LifesciencesIndiaAurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaActavis PharmaCarnegie PharmaceuticalsEdenbridge PharmaceuticalsHikma Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F). See USP Controlled Room Temperature.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
N03AG04 Vigabatrin
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
6 February 2019
Identifiers
RxCUI 199521DailyMed set ID 0afdc84c-f8ec-330a-31c9-fac4ed256931, 5ed8d293-b7d8-4c66-9c31-8075e6f99092, e9c99000-fc0c-4083-b620-ba9ac821f8ac +5NDC 43598-651, 0054-0652, 70771-1654 +5Application ANDA211539, ANDA213104, ANDA215707 +4

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
100 tablet, film coated in 1 bottle70710-1287-1Zydus LifesciencesIndia20 January 2022
100 tablet, film coated in 1 bottle70771-1654-1Zydus LifesciencesIndia20 January 2022
1 bottle in 1 carton / 100 tablet in 1 bottle59651-367-01Aurobindo PharmaIndia10 May 2022
100 tablet, film coated in 1 bottle43598-651-01Dr. Reddy's LaboratoriesIndia1 February 2021
100 tablet, film coated in 1 bottle0591-3851-01Actavis Pharma6 February 2019
1 bottle in 1 carton / 100 tablet, film coated in 1 bottle80005-167-11Carnegie Pharmaceuticals18 February 2026
100 tablet in 1 bottle42799-950-01Edenbridge Pharmaceuticals29 June 2022
100 tablet in 1 bottle0054-0652-25Hikma Pharmaceuticals9 September 2022

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 21 August 2009Drugs@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 Vigabatrin 500 mg tablet.

Compare all 2

Other strengths and forms of Vigabatrin

Clinical summary

Vigabatrin is an anti-epileptic agent indicated for the treatment of refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments, among other approved uses. MedsAcross supplies Vigabatrin 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 Vigabatrin

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

Data sources

Need Vigabatrin 500 mg tablet 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.