Product Information

VARENICLINE 0.5 MG TABLET is a generic product labeled by Florida Pharmaceutical Products, LLC, priced at $0.3364 per EA under NDC 71921030856. Its NADAC has been published 86 times since Jan 1, 2025.

FDA first approved this application on Oct 29, 2024. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.

VARENICLINE 0.5 MG TABLET

Varenicline tartrate
$0.3364per EA

Strength

.5 mg/1

NDC

71921030856

Classification

Generic

Dosage Form

TABLET, FILM COATED

Route

ORAL

Effective Date

8/19/2026

Active Ingredients

VARENICLINE TARTRATE

Approval Type

Generic (ANDA)

FDA Application

ANDA219106

FDA Approved

10/29/2024

TE Code

AB

On Market Since

11/1/2024

Pharmacological Classes

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

Price Statistics

The NADAC for VARENICLINE 0.5 MG TABLET has been published 86 times since Jan 1, 2025, and over the history we have for it it has declined 49.5%. The table below summarizes its recorded NADAC range and movement.

Current price$0.3364 per EA
All-time high$0.7722 (May 14, 2025)
All-time low$0.3191 (Jun 17, 2026)
52-week high$0.5253
52-week low$0.3191
Median price$0.3956
Average price$0.4992
Largest weekly change+18.1% (Jul 22, 2026)
Weeks tracked86
Tracking sinceJan 1, 2025

Price History

1W

-10.7%

1M

-10.7%

3M

-0.2%

6M

-0.7%

1Y

-36.0%

3Y

N/A

5Y

N/A

All

-49.5%

Generic Alternatives

The matcher finds 3 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 0.5 MG TABLET?

The current National Average Drug Acquisition Cost (NADAC) for VARENICLINE 0.5 MG TABLET, manufactured by Florida Pharmaceutical Products, LLC, is $0.3364 per EA (NDC 71921030856), effective Aug 19, 2026.

How has the price of VARENICLINE 0.5 MG TABLET changed over time?

Over the history we have for it, the NADAC for VARENICLINE 0.5 MG TABLET has declined 49.5%. It has been tracked across 86 weekly CMS publications since Jan 1, 2025.

What are the highest and lowest recorded NADAC prices for VARENICLINE 0.5 MG TABLET?

Since Jan 1, 2025, the NADAC for VARENICLINE 0.5 MG TABLET has ranged from a low of $0.3191 (Jun 17, 2026) to a high of $0.7722 (May 14, 2025), with a median of $0.3956 per EA.

Are there cheaper alternatives to VARENICLINE 0.5 MG TABLET?

3 manufacturers publish a NADAC-priced product with the same active ingredient and strength as VARENICLINE 0.5 MG TABLET in a comparable dosage form, but none are currently priced below it.

Who manufactures VARENICLINE 0.5 MG TABLET?

VARENICLINE 0.5 MG TABLET (NDC 71921030856) is labeled by Florida Pharmaceutical Products, LLC, and CMS classifies it as a generic product.