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.
Manufacturer
Leading Pharma, LLCNDC
69315040457
Classification
Generic
Dosage Form
KIT
Effective Date
5/20/2026
Approval Type
Generic (ANDA)
FDA Application
ANDA217151FDA 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 tracked | 131 |
| Tracking since | Dec 13, 2023 |
1W
N/A
1M
N/A
3M
N/A
6M
+1.1%
1Y
+5.3%
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 23% at current NADAC. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.
Related Drugs
Same classification
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Manufacturer
Leading Pharma, LLC manufacturer profile
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Drug market
VARENICLINE TARTRATE market comparison
Compare this molecule across participating manufacturers and inspect the broader market price spread.
Trend hub
Latest market trends
Zoom back out to the weekly mover view and compare this NDC with the rest of the current NADAC release.
Guide
Understanding NADAC pricing
Use the explainer when you need context on how CMS publishes NADAC and how to interpret the number on this page.
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 $0.3972 per EA — about 23% 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.