Product Information

VARENICLINE 1 MG TABLET is a generic product labeled by Macleods Pharmaceuticals Limited, priced at $0.3503 per EA under NDC 33342049019. Its NADAC has been published 51 times since Sep 3, 2025.

FDA first approved this application on Dec 9, 2024. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.

VARENICLINE 1 MG TABLET

Varenicline
$0.3503per EA

Strength

1 mg/1

NDC

33342049019

Classification

Generic

Dosage Form

TABLET, FILM COATED

Route

ORAL

Effective Date

8/19/2026

Active Ingredients

VARENICLINE TARTRATE

Approval Type

Generic (ANDA)

FDA Application

ANDA215048

FDA Approved

12/9/2024

TE Code

AB

On Market Since

12/10/2024

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 51 times since Sep 3, 2025, and over the history we have for it it has declined 31.5%. The table below summarizes its recorded NADAC range and movement.

Current price$0.3503 per EA
All-time high$0.5117 (Sep 10, 2025)
All-time low$0.3503 (Aug 19, 2026)
52-week high$0.5117
52-week low$0.3503
Median price$0.4278
Average price$0.4302
Largest weekly change-8.7% (Aug 19, 2026)
Weeks tracked51
Tracking sinceSep 3, 2025

Price History

1W

-8.7%

1M

-8.7%

3M

-13.0%

6M

-18.1%

1Y

N/A

3Y

N/A

5Y

N/A

All

-31.5%

Generic Alternatives

The matcher finds 2 manufacturers 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). None of the shown alternatives sit below the current price. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.

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 Macleods Pharmaceuticals Limited, is $0.3503 per EA (NDC 33342049019), effective Aug 19, 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 31.5%. It has been tracked across 51 weekly CMS publications since Sep 3, 2025.

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

Since Sep 3, 2025, the NADAC for VARENICLINE 1 MG TABLET has ranged from a low of $0.3503 (Aug 19, 2026) to a high of $0.5117 (Sep 10, 2025), with a median of $0.4278 per EA.

Are there cheaper alternatives to VARENICLINE 1 MG TABLET?

2 manufacturers publish a NADAC-priced product with the same active ingredient and strength as VARENICLINE 1 MG TABLET in a comparable dosage form, but none are currently priced below it.

Who manufactures VARENICLINE 1 MG TABLET?

VARENICLINE 1 MG TABLET (NDC 33342049019) is labeled by Macleods Pharmaceuticals Limited, and CMS classifies it as a generic product.