DrugDashboards

Varenicline

Varenicline · VARENICLINE TARTRATE 1 mg/1 · Tablet, Film Coated · Oral · Aurobindo Pharma Limited

NDC 59651-0418-55 · 1 BLISTER PACK in 1 CARTON / 56 TABLET, FILM COATED in 1 BLISTER PACK · ANDA · View full market →

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.

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

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA214595
TE code
AB
Approval date
May 2, 2025
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)

LabelerStrengthFirst seenLast seen
Aphena Pharma Solutions - Tennessee, LLCVARENICLINE TARTRATE 1 mg/1Aug 27, 2026Sep 3, 2026
A-S Medication SolutionsVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Apotex CorpVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Apotex CorpVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.VARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.VARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.VARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.VARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Nivagen Pharmaceuticals Inc.VARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Nivagen Pharmaceuticals Inc.VARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.VARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.VARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
A-S Medication SolutionsVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Aug 31, 2026
Mylan Pharmaceuticals Inc.VARENICLINE TARTRATE 1 mg/1Jul 15, 2026Jul 29, 2026

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

Cite this page

DrugDashboards, "Varenicline — NDC 59651-0418-55," retrieved September 3, 2026, https://drugdashboards.com/drug/59651041855.

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