DrugDashboards

Varenicline tartrate

Varenicline tartrate · VARENICLINE TARTRATE .5 mg/1 · Tablet, Film Coated · Oral · Indoco Remedies Limited

NDC 14445-0153-56 · 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 numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00069-0468-56) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

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

Plans pay at point of sale
$3.64per unit
middle half $3.64$3.64 · 4 plans · Apr 1, 2026
Est. net of rebates
≈ $3.64
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 4 · prior auth 0% · step therapy 0% · qty limit 100%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 2 quarters since 2024.

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 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
ANDA219106
TE code
AB
Approval date
Oct 29, 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 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 14445-0153-56," retrieved September 3, 2026, https://drugdashboards.com/drug/14445015356.

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