DrugDashboards

Varenicline Tartrate

Varenicline Tartrate · VARENICLINE TARTRATE .5 mg/561 · Tablet, Film Coated · Oral · Leading Pharma, LLC

NDC 69315-0402-56 · 56 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

22 companies supply this market — deep enough that no single failure threatens the supply. The generic price has fallen 56% in a year, to $0.3371 per unit — and generics that get this cheap tend to get abandoned rather than defended. The brand (Chantix) runs $3.40 per unit — 9.7× more. 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)$0.3371per EAinvoice-surveyed acquisition cost · May 20, 2026
  • Part D plans paid (avg)$3.50per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$0.3364per TABweighted avg manufacturer price $0.1335 · Aug 1, 2026100% of what pharmacies pay — a deeper discount than 90% 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$2.00$4.00Dec 2023Sep 2026$0.3371
31 price points · per EA · held since Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$10.11
#90 count
$30.33

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

Medicaid spend (2025)

$45,127
820 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 36% 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 tartrate (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
ANDA217151
TE code
AB
Approval date
Jul 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 Tartrate (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 3, 2026
American Health PackagingVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Ajanta Pharma USA Inc.VARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Ajanta Pharma USA Inc.VARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Aphena Pharma Solutions - Tennessee, LLCVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
AvKAREVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
AvKAREVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.VARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.VARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories Inc.VARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories Inc.VARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Florida Pharmaceutical Products, LLCVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Florida Pharmaceutical Products, LLCVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USAVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USAVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Indoco Remedies LimitedVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Indoco Remedies LimitedVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Kanchan Healthcare IncVARENICLINE TARTRATE .5 mg/561Jul 15, 2026Sep 2, 2026
Kanchan Healthcare IncVARENICLINE TARTRATE 1 mg/561Jul 15, 2026Sep 2, 2026
Leading Pharma, LLCVARENICLINE TARTRATE .5 mg/561Jul 15, 2026Sep 2, 2026
Leading Pharma, LLCVARENICLINE TARTRATE 1 mg/561Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Marlex Pharmaceuticals, Inc.VARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Marlex Pharmaceuticals, Inc.VARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Micro Labs LimitedVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Micro Labs LimitedVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Par Health USA, LLCVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Par Health USA, LLCVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Pfizer Laboratories Div Pfizer IncVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Pfizer Laboratories Div Pfizer IncVARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPVARENICLINE TARTRATE 1 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.VARENICLINE TARTRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Pfizer Italia S.r.l.VARENICLINE TARTRATE 1 kg/kgJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Varenicline Tartrate — NDC 69315-0402-56," retrieved September 3, 2026, https://drugdashboards.com/drug/69315040256.

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