Product Information
VARENICLINE 1 MG CONT MONTH BX is a generic product labeled by Leading Pharma, LLC, priced at $0.4026 per EA under NDC 69315040358. 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.
Strength
1 mg/561
Manufacturer
Leading Pharma, LLCNDC
69315040358
Classification
Generic
Dosage Form
TABLET, FILM COATED
Route
ORAL
Effective Date
5/20/2026
Active Ingredients
VARENICLINE TARTRATEApproval Type
Generic (ANDA)
FDA Application
ANDA217151FDA Approved
7/25/2023
TE Code
AB
On Market Since
10/1/2023
Pharmacological Classes
Price Statistics
The NADAC for VARENICLINE 1 MG CONT MONTH BX has been published 131 times since Dec 13, 2023, and over the history we have for it it has declined 91.0%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.4026 per EA |
|---|---|
| All-time high | $4.4794 (Dec 13, 2023) |
| All-time low | $0.4026 (May 20, 2026) |
| 52-week high | $0.5117 |
| 52-week low | $0.4026 |
| Median price | $0.5844 |
| Average price | $0.9725 |
| Largest weekly change | -51.0% (Nov 20, 2024) |
| Weeks tracked | 131 |
| Tracking since | Dec 13, 2023 |
1W
N/A
1M
N/A
3M
0.0%
6M
-5.9%
1Y
-21.3%
3Y
N/A
5Y
N/A
All
-91.0%
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). 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.
Related Drugs
Same classification
Frequently asked questions
What is the NADAC price of VARENICLINE 1 MG CONT MONTH BX?
The current National Average Drug Acquisition Cost (NADAC) for VARENICLINE 1 MG CONT MONTH BX, manufactured by Leading Pharma, LLC, is $0.4026 per EA (NDC 69315040358), effective Jun 10, 2026.
How has the price of VARENICLINE 1 MG CONT MONTH BX changed over time?
Over the history we have for it, the NADAC for VARENICLINE 1 MG CONT MONTH BX has declined 91.0%. It has been tracked across 131 weekly CMS publications since Dec 13, 2023.
What are the highest and lowest recorded NADAC prices for VARENICLINE 1 MG CONT MONTH BX?
Since Dec 13, 2023, the NADAC for VARENICLINE 1 MG CONT MONTH BX has ranged from a low of $0.4026 (May 20, 2026) to a high of $4.4794 (Dec 13, 2023), with a median of $0.5844 per EA.
Are there cheaper alternatives to VARENICLINE 1 MG CONT MONTH BX?
1 manufacturer publishes a NADAC-priced product with the same active ingredient and strength as VARENICLINE 1 MG CONT MONTH BX in a comparable dosage form, but none are currently priced below it.
Who manufactures VARENICLINE 1 MG CONT MONTH BX?
VARENICLINE 1 MG CONT MONTH BX (NDC 69315040358) is labeled by Leading Pharma, LLC, and CMS classifies it as a generic product.