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Medicine

Guanfacine 2 mg tablet

Guanfacine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Guanfacine 2 mg tablet is a generic prescription medicine for oral use, made by 17 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 20º to 25 ºC (68 º to 77 ºF).

Key facts

Active ingredient (INN)
Guanfacine
Brand
Sold under the generic name
Strength
2 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 1000 tablets, 500 tablets and 23 more
Manufacturers
Ajanta PharmaIndiaAurobindo PharmaIndiaUnichem LaboratoriesIndiaAdvagen PharmaAmneal PharmaceuticalsRemedyrepackXiromedA2A Integrated PharmaceuticalsActavis PharmaAmneal Pharmaceuticals of New York
Origin register
US FDA, United States
Storage
Store at 20º to 25 ºC (68 º to 77 ºF).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
C02AC02 Guanfacine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
17 October 1995
Identifiers
RxCUI 197745, 197746DailyMed set ID 73d50917-c807-4213-8efe-aea209845936, fa7ae501-ee34-4e50-9052-7952e36bbd0e, 4248d53e-4dc3-452b-96f8-5d715c254c26 +16NDC 53746-713, 62135-728, 70518-4488 +16Application ANDA075109, ANDA216399, ANDA217293 +7

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 in 1 bottle27241-243-01Ajanta PharmaIndia27 April 2023
100 tablet in 1 bottle59651-841-01Aurobindo PharmaIndia7 August 2023
100 tablet in 1 bottle29300-459-01Unichem LaboratoriesIndia5 April 2021
100 tablet in 1 bottle73141-019-04A2A Integrated Pharmaceuticals8 April 2025
100 tablet in 1 bottle0591-0453-01Actavis Pharma17 October 1995
1000 tablet in 1 bottle72888-124-00Advagen Pharma1 October 2021
100 tablet in 1 bottle72888-124-01Advagen Pharma1 October 2021
500 tablet in 1 bottle72888-124-05Advagen Pharma1 October 2021
30 tablet in 1 bottle72888-124-30Advagen Pharma1 October 2021
30 tablet in 1 bottle65162-713-03Amneal Pharmaceuticals25 November 1998
100 tablet in 1 bottle65162-713-10Amneal Pharmaceuticals25 November 1998
500 tablet in 1 bottle65162-713-50Amneal Pharmaceuticals25 November 1998
100 tablet in 1 bottle53746-713-01Amneal Pharmaceuticals of New York15 April 2022
90 tablet in 1 bottle62135-728-90Chartwell RX12 July 2023
100 tablet in 1 bottle42806-296-01Epic Pharma30 May 2019
100 tablet in 1 bottle72319-019-04i3 Pharmaceuticals31 October 2022
100 tablet in 1 bottle24979-199-01TWi Pharmaceuticals1 September 2022
100 tablet in 1 bottle70700-302-01Xiromed24 February 2024
500 tablet in 1 bottle70700-302-05Xiromed24 February 2024
30 tablet in 1 bottle70700-302-30Xiromed24 February 2024
30 tablet in 1 blister pack70518-3516-0Remedyrepack13 September 2022
30 tablet in 1 blister pack70518-4488-0Remedyrepack30 September 2025
30 tablet in 1 blister pack70518-4564-0Remedyrepack3 February 2026
50 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack50268-374-15AvPAK7 June 2017
30 tablet in 1 blister pack67046-1655-3Coupler28 January 2026
100 tablet in 1 bottle72603-269-01Northstar RX15 July 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 27 October 1986Drugs@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

Other strengths and forms of Guanfacine

Clinical summary

Guanfacine is a central alpha-2 adrenergic agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. It is available as extended-release tablets and tablets for oral use. MedsAcross supplies Guanfacine 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 Guanfacine

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

Data sources

Need Guanfacine 2 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.