Medicine
Varenicline 0.5 mg tablet
Varenicline 0.5 mg tablet is a generic prescription medicine for oral use, made by 24 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°C to 30°C…
Key facts
- Active ingredient (INN)
- Varenicline
- Brand
- Sold under the generic name
- Strength
- 0.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 56 tablets, 60 blister pack, 50 blister pack and 25 more
- Manufacturers
- Umedica LaboratoriesIndiaZydus LifesciencesIndiaAjanta PharmaIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaGlenmark PharmaceuticalsIndiaIndoco RemediesIndiaMacleods PharmaceuticalsIndia24 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F 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 2f86bb7b-c6a6-4915-8ba1-17251540971c, 1297c291-da28-4a73-9c28-d5adee36d7b7, 7bd1abc8-2689-496b-b3f2-1cefe218ff5a +25NDC 27241-173, 0904-7413, 31722-678 +26Application ANDA213019, ANDA214557, 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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 56 tablet, film coated in 1 bottle | 70710-1613-6 | Zydus LifesciencesIndia | 13 June 2023 |
| 56 tablet, film coated in 1 bottle | 70771-1773-6 | Zydus LifesciencesIndia | 13 June 2023 |
| 56 tablet, film coated in 1 bottle | 27241-173-56 | Ajanta PharmaIndia | 31 January 2024 |
| 56 tablet, film coated in 1 bottle | 67877-743-95 | Ascend LaboratoriesIndia | 25 August 2023 |
| 56 tablet, film coated in 1 bottle | 59651-417-56 | Aurobindo PharmaIndia | 2 May 2025 |
| 56 tablet, film coated in 1 bottle | 31722-678-56 | Camber PharmaceuticalsIndia | 23 October 2023 |
| 56 tablet, film coated in 1 bottle | 43598-907-56 | Dr. Reddy's LaboratoriesIndia | 13 December 2024 |
| 56 tablet, film coated in 1 bottle | 68462-893-56 | Glenmark PharmaceuticalsIndia | 22 August 2023 |
| 56 tablet, film coated in 1 bottle | 14445-153-56 | Indoco RemediesIndia | 1 November 2024 |
| 56 tablet, film coated in 1 bottle | 33342-489-19 | Macleods PharmaceuticalsIndia | 10 December 2024 |
| 56 tablet, film coated in 1 bottle | 42571-459-82 | Micro LabsIndia | 1 December 2025 |
| 56 tablet in 1 bottle | 60290-077-01 | Umedica LaboratoriesIndia | 9 January 2026 |
| 60 blister pack in 1 carton / 1 tablet in 1 blister pack | 60290-077-02 | Umedica LaboratoriesIndia | 9 January 2026 |
| 56 tablet, film coated in 1 bottle | 60505-3613-5 | Apotex | 30 January 2023 |
| 56 tablet, film coated in 1 bottle | 71921-308-56 | Florida Pharmaceutical Products | 1 November 2024 |
| 56 tablet, film coated in 1 bottle | 85742-015-15 | Kanchan Healthcare | 1 October 2023 |
| 56 tablet, film coated in 1 bottle | 69315-402-56 | Leading Pharma | 1 October 2023 |
| 56 tablet, film coated in 1 bottle | 49884-155-76 | Par Health | 21 September 2021 |
| 56 tablet, film coated in 1 bottle | 50090-6447-0 | A-S Medication Solutions | 20 April 2023 |
| 56 tablet, film coated in 1 bottle | 50090-7135-0 | A-S Medication Solutions | 19 April 2024 |
| 56 tablet, film coated in 1 bottle | 50090-7996-0 | A-S Medication Solutions | 17 June 2026 |
| 56 tablet, film coated in 1 bottle | 50090-8088-0 | A-S Medication Solutions | 21 September 2026 |
| 56 tablet, film coated in 1 bottle | 42291-927-56 | AvKARE | 14 September 2023 |
| 56 tablet, film coated in 1 bottle | 72162-2218-2 | Bryant Ranch Prepack | 30 January 2023 |
| 56 tablet, film coated in 1 bottle | 0904-7413-35 | Major Pharmaceuticals | 18 December 2023 |
| 56 tablet, film coated in 1 bottle | 10135-808-56 | Marlex Pharmaceuticals | 1 January 2025 |
| 56 tablet, film coated in 1 bottle | 72603-476-01 | NorthStar RxLLC | 23 September 2024 |
| 50 blister pack in 1 box / 1 tablet, film coated in 1 blister pack | 70518-4647-0 | Remedyrepack | 29 April 2026 |
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 0.5 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 0.5 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.