The short version
11 companies supply this market — deep enough that no single failure threatens the supply.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Varenicline
Varenicline · VARENICLINE TARTRATE .5 mg/1 · Tablet, Film Coated · Oral · Zydus Lifesciences Limited
NDC 70771-1773-06 · 56 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for varenicline (oral solid) in the next 90 days
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- analysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA216723
- TE code
- AB
- Approval date
- Jun 12, 2023
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Varenicline (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | VARENICLINE TARTRATE 1 mg/1 | Aug 27, 2026 | Sep 3, 2026 |
| A-S Medication Solutions | VARENICLINE TARTRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Apotex Corp | VARENICLINE TARTRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Apotex Corp | VARENICLINE TARTRATE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | VARENICLINE TARTRATE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | VARENICLINE TARTRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | VARENICLINE TARTRATE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | VARENICLINE TARTRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Golden State Medical Supply, Inc. | VARENICLINE TARTRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Golden State Medical Supply, Inc. | VARENICLINE TARTRATE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | VARENICLINE TARTRATE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | VARENICLINE TARTRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | VARENICLINE TARTRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | VARENICLINE TARTRATE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Nivagen Pharmaceuticals Inc. | VARENICLINE TARTRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Nivagen Pharmaceuticals Inc. | VARENICLINE TARTRATE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | VARENICLINE TARTRATE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | VARENICLINE TARTRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | VARENICLINE TARTRATE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | VARENICLINE TARTRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| A-S Medication Solutions | VARENICLINE TARTRATE 1 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Mylan Pharmaceuticals Inc. | VARENICLINE TARTRATE 1 mg/1 | Jul 15, 2026 | Jul 29, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Varenicline — NDC 70771-1773-06," retrieved September 3, 2026, https://drugdashboards.com/drug/70771177306.
Free to cite with attribution — see how the data is put together.