DrugDashboards

Varenicline

Varenicline · VARENICLINE TARTRATE 1 mg/1 · Tablet, Film Coated · Oral · Mylan Pharmaceuticals Inc.

NDC 00378-5090-73 · 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC · ANDA · View full market →

The short version

11 companies supply this market — deep enough that no single failure threatens the supply. The price is down 29% over the past year, to $0.3837 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.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$0.3837per EAinvoice-surveyed acquisition cost · Jul 22, 2026
  • Medicaid generic ceiling (FUL)$0.3503per TABweighted avg manufacturer price $0.1596 · Aug 1, 202691% of what pharmacies pay — a deeper discount than 95% of drugs with this benchmark

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$0.5$1.00$1.50Aug 2024Sep 2026$0.3837
25 price points · per EA · held since Jul 22, 2026 · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$11.51
#90 count
$34.53

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$519,094
5,622 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

8● Low risk

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

  • price down 25% 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 (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 →

Regulatory

Application
ANDA202019
TE code
AB
Approval date
Feb 28, 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 (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 00378-5090-73," retrieved September 3, 2026, https://drugdashboards.com/drug/00378509073.

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