Product Information

VARENICLINE 1 MG TABLET is a generic product labeled by Leading Pharma, LLC, priced at $0.4278 per EA under NDC 69315040356. Its NADAC has been published 115 times since Dec 13, 2023.

FDA first approved this application on Jul 25, 2023. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.

The High Outlier badge above means this manufacturer's average price in the VARENICLINE TARTRATE market falls above Q3 + 1.5·IQR across all competing manufacturers. We only apply this flag in markets with four or more competitors. Full definition: glossary → outlier.

VARENICLINE 1 MG TABLET

VARENICLINE TARTRATE
$0.4278per EA
High Outlier

Strength

1 mg/561

NDC

69315040356

Classification

Generic

Dosage Form

TABLET, FILM COATED

Route

ORAL

Effective Date

2/18/2026

Active Ingredients

VARENICLINE TARTRATE

Approval Type

Generic (ANDA)

FDA Application

ANDA217151

FDA Approved

7/25/2023

TE Code

AB

On Market Since

10/1/2023

Pharmacological Classes

Cholinergic Agonists
Cholinergic Receptor Agonist
Partial Cholinergic Nicotinic Agonist
Partial Cholinergic Nicotinic Agonists

Price Statistics

The NADAC for VARENICLINE 1 MG TABLET has been published 115 times since Dec 13, 2023, and over the history we have for it it has declined 90.5%. The table below summarizes its recorded NADAC range and movement.

Current price$0.4278 per EA
All-time high$4.4794 (Dec 13, 2023)
All-time low$0.4278 (Feb 18, 2026)
52-week high$0.5117
52-week low$0.4278
Median price$0.5970
Average price$1.0504
Largest weekly change-51.0% (Nov 20, 2024)
Weeks tracked115
Tracking sinceDec 13, 2023

Price History

1W

N/A

1M

N/A

3M

N/A

6M

N/A

1Y

-16.4%

3Y

N/A

5Y

N/A

All

-90.5%

Last surveyed Feb 18, 2026 — this NDC no longer appears in the current weekly NADAC file.

Generic Alternatives

The matcher finds 1 manufacturer offering a NADAC-published product with this drug's active ingredient and strength in a comparable dosage form (cheapest from each manufacturer, up to 10 shown below). Switching to the cheapest would cut per-unit acquisition cost by roughly 6% at current NADAC. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.

Lowest-Cost Alternatives

Save up to 6%

1 alternative • Same active ingredient

Frequently asked questions

What is the NADAC price of VARENICLINE 1 MG TABLET?

The current National Average Drug Acquisition Cost (NADAC) for VARENICLINE 1 MG TABLET, manufactured by Leading Pharma, LLC, is $0.4278 per EA (NDC 69315040356), effective Feb 18, 2026.

How has the price of VARENICLINE 1 MG TABLET changed over time?

Over the history we have for it, the NADAC for VARENICLINE 1 MG TABLET has declined 90.5%. It has been tracked across 115 weekly CMS publications since Dec 13, 2023.

What are the highest and lowest recorded NADAC prices for VARENICLINE 1 MG TABLET?

Since Dec 13, 2023, the NADAC for VARENICLINE 1 MG TABLET has ranged from a low of $0.4278 (Feb 18, 2026) to a high of $4.4794 (Dec 13, 2023), with a median of $0.5970 per EA.

Are there cheaper alternatives to VARENICLINE 1 MG TABLET?

Yes. 1 manufacturer publishes a NADAC-priced product with the same active ingredient and strength in a comparable dosage form. The lowest-priced option, VARENICLINE 1 MG CONT MONTH BX, is $0.4026 per EA — about 6% below VARENICLINE 1 MG TABLET.

Who manufactures VARENICLINE 1 MG TABLET?

VARENICLINE 1 MG TABLET (NDC 69315040356) is labeled by Leading Pharma, LLC, and CMS classifies it as a generic product.