Product Information

VARENICLINE STARTING MONTH BOX is a generic product labeled by Leading Pharma, LLC, priced at $0.5154 per EA under NDC 69315040457. Its NADAC has been published 131 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 STARTING MONTH BOX

VARENICLINE TARTRATE
$0.5154per EA
High Outlier

NDC

69315040457

Classification

Generic

Dosage Form

KIT

Effective Date

5/20/2026

Approval Type

Generic (ANDA)

FDA Application

ANDA217151

FDA Approved

7/25/2023

TE Code

AB

On Market Since

10/1/2023

Price Statistics

The NADAC for VARENICLINE STARTING MONTH BOX has been published 131 times since Dec 13, 2023, and over the history we have for it it has declined 91.5%. The table below summarizes its recorded NADAC range and movement.

Current price$0.5154 per EA
All-time high$6.0976 (Dec 13, 2023)
All-time low$0.4066 (Nov 20, 2024)
52-week high$0.5229
52-week low$0.4856
Median price$0.6296
Average price$1.3108
Largest weekly change+71.9% (Dec 18, 2024)
Weeks tracked131
Tracking sinceDec 13, 2023

Price History

1W

N/A

1M

N/A

3M

0.0%

6M

+1.5%

1Y

-0.7%

3Y

N/A

5Y

N/A

All

-91.5%

Last surveyed Jun 10, 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 20% at current NADAC. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.

Lowest-Cost Alternatives

Save up to 20%

1 alternative • Same active ingredient

Related Drugs

Same classification

No related drugs found.

Frequently asked questions

What is the NADAC price of VARENICLINE STARTING MONTH BOX?

The current National Average Drug Acquisition Cost (NADAC) for VARENICLINE STARTING MONTH BOX, manufactured by Leading Pharma, LLC, is $0.5154 per EA (NDC 69315040457), effective Jun 10, 2026.

How has the price of VARENICLINE STARTING MONTH BOX changed over time?

Over the history we have for it, the NADAC for VARENICLINE STARTING MONTH BOX has declined 91.5%. It has been tracked across 131 weekly CMS publications since Dec 13, 2023.

What are the highest and lowest recorded NADAC prices for VARENICLINE STARTING MONTH BOX?

Since Dec 13, 2023, the NADAC for VARENICLINE STARTING MONTH BOX has ranged from a low of $0.4066 (Nov 20, 2024) to a high of $6.0976 (Dec 13, 2023), with a median of $0.6296 per EA.

Are there cheaper alternatives to VARENICLINE STARTING MONTH BOX?

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 STARTING MONTH BOX, is $0.4122 per EA — about 20% below VARENICLINE STARTING MONTH BOX.

Who manufactures VARENICLINE STARTING MONTH BOX?

VARENICLINE STARTING MONTH BOX (NDC 69315040457) is labeled by Leading Pharma, LLC, and CMS classifies it as a generic product.