DrugDashboards

Varenicline

Varenicline · Kit · Oral · Apotex Corp

NDC 60505-3615-04 · 1 KIT in 1 CARTON * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK · ANDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble. The price is down 27% over the past year, to $0.4122 per unit. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

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

$0$2.00$4.00Feb 2024Sep 2026$0.4122
32 price points · per EASource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$247.87
Reported to Texas DSHS · 2026 annual filing · Apotex Corp

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2024)

$185,510
1,196 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

13Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 5 active manufacturers+5
  • price down 21% year over year+8

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

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 →

Regulatory

Application
ANDA201962
TE code
AB
Approval date
Jan 25, 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 (Kit)

LabelerStrengthFirst seenLast seen
Apotex CorpJul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedJul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedJul 15, 2026Sep 2, 2026
Nivagen Pharmaceuticals Inc.Jul 15, 2026Sep 2, 2026
Umedica Laboratories USA Inc.Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Varenicline — NDC 60505-3615-04," retrieved September 3, 2026, https://drugdashboards.com/drug/60505361504.

Free to cite with attribution — see how the data is put together.