Medicine
Clonidine 0.1 mg extended-release tablet
Clonidine 0.1 mg extended-release tablet is a generic prescription medicine for oral use, made by 10 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° to 25°C (68°-77°F), excursions permitted to 15° to 30°C (59° to…
Key facts
- Active ingredient (INN)
- Clonidine
- Brand
- Sold under the generic name
- Strength
- 0.1 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 60 tablets, 500 tablets, 30 tablets and 9 more
- Manufacturers
- Ajanta PharmaIndiaLupinIndiaIngenus PharmaceuticalsActavis PharmaAmerican Health PackagingBluePoint LaboratoriesBryant Ranch PrepackSolco HealthcareSomerset TherapeuticsXiamen LP Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68°-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
- C02AC01 Clonidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 June 2015
- Identifiers
- RxCUI 1013930DailyMed set ID df80255e-f942-4d9f-8edd-cc95795772cb, 03a53175-d301-4001-b28b-78ecd763c4ae, 7676af27-4d8f-49c4-a50f-6b0892e73c8f +7NDC 27241-108, 43547-435, 71034-001 +7Application ANDA209686, ANDA209757, ANDA211433 +3
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 |
|---|---|---|---|
| 60 tablet, extended release in 1 bottle | 27241-108-06 | Ajanta PharmaIndia | 21 November 2017 |
| 60 tablet, extended release in 1 bottle | 68180-606-07 | LupinIndia | 7 February 2018 |
| 60 tablet, extended release in 1 bottle | 0228-4241-06 | Actavis Pharma | 17 June 2015 |
| 500 tablet, extended release in 1 bottle | 50742-247-05 | Ingenus Pharmaceuticals | 5 March 2019 |
| 30 tablet, extended release in 1 bottle | 50742-247-30 | Ingenus Pharmaceuticals | 5 March 2019 |
| 60 tablet, extended release in 1 bottle | 50742-247-60 | Ingenus Pharmaceuticals | 5 March 2019 |
| 60 tablet, extended release in 1 bottle | 43547-435-06 | Solco Healthcare | 15 February 2018 |
| 60 tablet, extended release in 1 bottle | 70069-044-01 | Somerset Therapeutics | 4 March 2025 |
| 60 tablet, extended release in 1 bottle | 71034-001-60 | Xiamen LP Pharmaceutical | 1 December 2017 |
| 30 blister pack in 1 box, unit-dose / 1 tablet, extended release in 1 blister pack | 60687-462-21 | American Health Packaging | 17 December 2019 |
| 60 tablet, extended release in 1 bottle | 68001-568-06 | BluePoint Laboratories | 24 August 2023 |
| 60 tablet, extended release in 1 bottle | 72162-1367-6 | Bryant Ranch Prepack | 16 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 3 September 1974 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 Clonidine
Clinical summary
Clonidine is a central alpha-2 adrenergic agonist indicated in the treatment of hypertension. It is available as tablets, transdermal patches and extended-release tablets for oral and epidural use. MedsAcross supplies Clonidine 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 ClonidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Clonidine Transdermal System USP, 0.1 mg/day prescribing information (TruPharma) · U.S. National Library of Medicine, DailyMed
Need Clonidine 0.1 mg extended-release 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.