The short version
5 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
varenicline
varenicline · Kit · Nivagen Pharmaceuticals Inc.
NDC 75834-0336-24 · 2 BOX in 1 KIT / 1 KIT in 1 BOX * 1 BLISTER PACK in 1 BOX / 11 TABLET, FILM COATED in 1 BLISTER PACK * 3 BLISTER PACK in 1 BOX / 14 TABLET, FILM COATED in 1 BLISTER PACK · 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 (other) 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 · pack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA217115
- TE code
- AB
- Approval date
- Jul 23, 2024
- 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 (Kit)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Apotex Corp | Jul 15, 2026 | Sep 2, 2026 | |
| Aurobindo Pharma Limited | Jul 15, 2026 | Sep 2, 2026 | |
| Macleods Pharmaceuticals Limited | Jul 15, 2026 | Sep 2, 2026 | |
| Nivagen Pharmaceuticals Inc. | Jul 15, 2026 | Sep 2, 2026 | |
| Umedica Laboratories USA Inc. | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "varenicline — NDC 75834-0336-24," retrieved September 3, 2026, https://drugdashboards.com/drug/75834033624.
Free to cite with attribution — see how the data is put together.