Medicine
Guanfacine 1 mg extended-release tablet
Guanfacine 1 mg extended-release tablet is a generic prescription medicine for oral use, made by 15 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
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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Guanfacine
- Brand
- Sold under the generic name
- Strength
- 1 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 500 tablets and 32 more
- Manufacturers
- Alembic PharmaceuticalsIndiaUnichem LaboratoriesIndiaProficient RxAdvagen PharmaBryant Ranch PrepackDirect_RxRemedyrepackUpsher-Smith LaboratoriesGolden State Medical SupplyActavis Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 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
- C02AC02 Guanfacine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 December 2014
- Identifiers
- RxCUI 862006, 862013, 862019 +1DailyMed set ID 983b3157-cbea-435d-ba32-9ee7ef95226a, 4b86e1c1-9cbe-d4a9-e063-6294a90a2274, 35d3c996-1755-c017-e063-6294a90abc1f +20NDC 46708-745, 51407-952, 60760-863 +20Application ANDA217269, ANDA205689, ANDA205430 +6
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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, extended release in 1 bottle | 46708-745-31 | Alembic PharmaceuticalsIndia | 8 August 2023 |
| 1000 tablet, extended release in 1 bottle | 46708-745-91 | Alembic PharmaceuticalsIndia | 8 August 2023 |
| 100 tablet, extended release in 1 bottle | 62332-745-31 | Alembic PharmaceuticalsIndia | 8 August 2023 |
| 1000 tablet, extended release in 1 bottle | 62332-745-91 | Alembic PharmaceuticalsIndia | 8 August 2023 |
| 100 tablet, extended release in 1 bottle, plastic | 29300-460-01 | Unichem LaboratoriesIndia | 1 February 2025 |
| 100 tablet, extended release in 1 bottle | 0228-2850-11 | Actavis Pharma | 1 December 2014 |
| 1000 tablet, extended release in 1 bottle | 72888-224-00 | Advagen Pharma | 15 April 2025 |
| 100 tablet, extended release in 1 bottle | 72888-224-01 | Advagen Pharma | 15 April 2025 |
| 500 tablet, extended release in 1 bottle | 72888-224-05 | Advagen Pharma | 15 April 2025 |
| 30 tablet, extended release in 1 bottle | 72888-224-30 | Advagen Pharma | 15 April 2025 |
| 100 tablet, extended release in 1 bottle | 60505-3927-1 | Apotex | 3 October 2018 |
| 100 tablet, extended release in 1 bottle | 72266-255-55 | Fosun Pharma | 1 October 2025 |
| 100 tablet, extended release in 1 bottle | 70436-039-01 | Slate Run Pharmaceuticals | 1 August 2022 |
| 100000 tablet, extended release in 1 drum | 24979-533-00 | Upsher-Smith Laboratories | 1 July 2024 |
| 100 tablet, extended release in 1 bottle | 24979-533-01 | Upsher-Smith Laboratories | 7 July 2017 |
| 1000 tablet, extended release in 1 bottle | 24979-533-10 | Upsher-Smith Laboratories | 7 July 2017 |
| 30 tablet, extended release in 1 bottle | 63629-8161-1 | Bryant Ranch Prepack | 2 July 2019 |
| 30 tablet, extended release in 1 bottle | 71335-2379-1 | Bryant Ranch Prepack | 27 March 2024 |
| 30 tablet, extended release in 1 bottle | 71335-3078-1 | Bryant Ranch Prepack | 13 February 2026 |
| 100 tablet, extended release in 1 bottle | 72162-1798-1 | Bryant Ranch Prepack | 17 August 2018 |
| 30 tablet, extended release in 1 bottle | 72189-469-30 | Direct_Rx | 4 May 2023 |
| 30 tablet, extended release in 1 bottle | 72189-597-30 | Direct_rx | 3 December 2024 |
| 30 tablet, extended release in 1 bottle | 72189-693-30 | Direct_Rx | 2 October 2026 |
| 100 tablet, extended release in 1 bottle | 51407-952-01 | Golden State Medical Supply | 12 January 2026 |
| 100 tablet, extended release in 1 bottle | 60429-960-01 | Golden State Medical Supply | 6 October 2017 |
| 30 tablet, extended release in 1 blister pack | 70518-2771-0 | Remedyrepack | 8 June 2020 |
| 100 pouch in 1 box / 1 tablet, extended release in 1 pouch | 70518-2771-1 | Remedyrepack | 27 January 2025 |
| 30 tablet, extended release in 1 blister pack | 70518-4539-0 | Remedyrepack | 23 December 2025 |
| 100 tablet, extended release in 1 bottle | 16714-190-01 | Northstar Rxllc | 17 September 2021 |
| 100 tablet, extended release in 1 bottle | 71205-944-00 | Proficient Rx | 19 November 2020 |
| 30 tablet, extended release in 1 bottle | 71205-944-30 | Proficient Rx | 19 November 2020 |
| 500 tablet, extended release in 1 bottle | 71205-944-55 | Proficient Rx | 19 November 2020 |
| 60 tablet, extended release in 1 bottle | 71205-944-60 | Proficient Rx | 19 November 2020 |
| 90 tablet, extended release in 1 bottle | 71205-944-90 | Proficient Rx | 19 November 2020 |
| 30 tablet, extended release in 1 bottle, plastic | 60760-863-30 | St. Mary's Medical Park Pharmacy | 19 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.
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 Guanfacine 1 mg extended-release tablet.
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 GuanfacineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Intuniv prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Intuniv: European public assessment report (EPAR) · European Medicines Agency
- Paxneury: European public assessment report (EPAR) · European Medicines Agency
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