Medicine
Varenicline 1 mg tablet
Varenicline 1 mg tablet is a generic prescription medicine for oral use, made by 25 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° to 77°F), excursions permitted to 15°C to 30°C (59°…
Key facts
- Active ingredient (INN)
- Varenicline
- Brand
- Sold under the generic name
- Strength
- 1 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 56 tablets, 4 blister pack, 1 blister pack and 38 more
- Manufacturers
- Umedica LaboratoriesIndiaAjanta PharmaIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaGlenmark PharmaceuticalsIndiaIndoco RemediesIndiaMacleods PharmaceuticalsIndiaMicro LabsIndiaZydus LifesciencesIndia25 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°c to 25°C (68° to 77°F), excursions permitted to 15°C 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
- N07BA03 Varenicline
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 September 2021
- Identifiers
- RxCUI 636671, 636676, 749289 +1DailyMed set ID c325d582-8f43-40ea-b348-87837de97a07, 9e5c0ef3-3179-4d7b-bc76-901473c73ce8, 6a6f674f-cf2e-40c2-8678-27cb476332cb +26NDC 33342-490, 49884-156, 50090-8184 +27Application ANDA215048, ANDA201785, ANDA214571 +13
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
A sample of 40 packs from 25 labelers. The register lists 41 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 56 tablet, film coated in 1 bottle | 70710-1614-6 | Zydus LifesciencesIndia | 13 June 2023 |
| 56 tablet, film coated in 1 bottle | 70771-1774-6 | Zydus LifesciencesIndia | 13 June 2023 |
| 56 tablet, film coated in 1 bottle | 27241-174-56 | Ajanta PharmaIndia | 31 January 2024 |
| 4 blister pack in 1 carton / 56 tablet, film coated in 1 blister pack | 27241-174-77 | Ajanta PharmaIndia | 31 January 2024 |
| 1 blister pack in 1 carton / 56 tablet, film coated in 1 blister pack | 67877-744-54 | Ascend LaboratoriesIndia | 25 August 2023 |
| 56 tablet, film coated in 1 bottle | 67877-744-95 | Ascend LaboratoriesIndia | 25 August 2023 |
| 1 blister pack in 1 carton / 56 tablet, film coated in 1 blister pack | 59651-418-55 | Aurobindo PharmaIndia | 2 May 2025 |
| 56 tablet, film coated in 1 bottle | 59651-418-56 | Aurobindo PharmaIndia | 2 May 2025 |
| 1 blister pack in 1 carton / 56 tablet, film coated in 1 blister pack | 31722-679-31 | Camber PharmaceuticalsIndia | 23 October 2023 |
| 56 tablet, film coated in 1 bottle | 31722-679-56 | Camber PharmaceuticalsIndia | 23 October 2023 |
| 56 tablet, film coated in 1 bottle | 43598-908-56 | Dr. Reddy's LaboratoriesIndia | 13 December 2024 |
| 1 blister pack in 1 carton / 56 tablet, film coated in 1 blister pack | 68462-894-04 | Glenmark PharmaceuticalsIndia | 22 August 2023 |
| 56 tablet, film coated in 1 bottle | 68462-894-56 | Glenmark PharmaceuticalsIndia | 22 August 2023 |
| 1 blister pack in 1 carton / 56 tablet, film coated in 1 blister pack | 14445-154-02 | Indoco RemediesIndia | 1 November 2024 |
| 56 tablet, film coated in 1 bottle | 14445-154-56 | Indoco RemediesIndia | 1 November 2024 |
| 56 tablet, film coated in 1 bottle | 33342-490-19 | Macleods PharmaceuticalsIndia | 10 December 2024 |
| 1 blister pack in 1 carton / 56 tablet, film coated in 1 blister pack | 33342-490-27 | Macleods PharmaceuticalsIndia | 10 December 2024 |
| 56 tablet, film coated in 1 bottle | 42571-460-82 | Micro LabsIndia | 1 December 2025 |
| 1 blister pack in 1 carton / 56 tablet, film coated in 1 blister pack | 42571-460-88 | Micro LabsIndia | 1 December 2025 |
| 56 tablet in 1 bottle | 60290-078-01 | Umedica LaboratoriesIndia | 9 January 2026 |
| 60 blister pack in 1 carton / 1 tablet in 1 blister pack | 60290-078-02 | Umedica LaboratoriesIndia | 9 January 2026 |
| 56 tablet in 1 blister pack | 60290-078-03 | Umedica LaboratoriesIndia | 17 April 2026 |
| 56 tablet, film coated in 1 bottle | 60505-3614-5 | Apotex | 30 January 2023 |
| 56 tablet, film coated in 1 bottle | 71921-309-56 | Florida Pharmaceutical Products | 1 November 2024 |
| 56 tablet, film coated in 1 bottle | 85742-016-15 | Kanchan Healthcare | 1 October 2023 |
| 1 blister pack in 1 box / 56 tablet, film coated in 1 blister pack | 85742-016-16 | Kanchan Healthcare | 1 October 2023 |
| 56 tablet, film coated in 1 bottle | 69315-403-56 | Leading Pharma | 1 October 2023 |
| 1 blister pack in 1 box / 56 tablet, film coated in 1 blister pack | 69315-403-58 | Leading Pharma | 1 October 2023 |
| 56 tablet, film coated in 1 bottle | 49884-156-76 | Par Health | 21 September 2021 |
| 56 tablet, film coated in 1 bottle | 50090-6446-0 | A-S Medication Solutions | 20 April 2023 |
| 56 tablet, film coated in 1 bottle | 50090-7182-0 | A-S Medication Solutions | 11 June 2024 |
| 56 tablet, film coated in 1 bottle | 50090-7997-0 | A-S Medication Solutions | 17 June 2026 |
| 56 tablet, film coated in 1 bottle | 50090-8184-0 | A-S Medication Solutions | 4 November 2026 |
| 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 60687-893-21 | American Health Packaging | 9 December 2025 |
| 1008 tablet, film coated in 1 bottle | 53401-032-84 | Aphena Pharma Solutions - Tennessee | 25 August 2026 |
| 56 tablet, film coated in 1 bottle | 42291-928-56 | AvKARE | 14 September 2023 |
| 56 tablet, film coated in 1 bottle | 72162-2219-2 | Bryant Ranch Prepack | 5 January 2024 |
| 30 tablet, film coated in 1 bottle | 72162-2219-3 | Bryant Ranch Prepack | 5 January 2024 |
| 56 tablet, film coated in 1 bottle | 0904-7414-35 | Major Pharmaceuticals | 18 December 2023 |
| 56 tablet, film coated in 1 bottle | 10135-809-56 | Marlex Pharmaceuticals | 1 January 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 Varenicline 1 mg tablet.
Other strengths and forms of Varenicline
Clinical summary
Varenicline is a partial cholinergic nicotinic agonist indicated as an aid to smoking-cessation treatment. It is available as tablets, kits and nasal spray for oral use. MedsAcross supplies Varenicline 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 VareniclineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CHANTIX prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
- Champix: European public assessment report (EPAR) · European Medicines Agency
Need Varenicline 1 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.