varenicline

varenicline · Kit · Umedica Laboratories USA Inc.

NDC 60290-0095-01 · 1 KIT in 1 BLISTER PACK * 11 TABLET in 1 BLISTER PACK * 42 TABLET 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 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 (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: ANDA218985
TE code: AB
Approval date: Jan 9, 2026
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	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 60290-0095-01," retrieved September 3, 2026, https://drugdashboards.com/drug/60290009501.

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