Product Information
VARENICLINE 0.5 MG TABLET is a generic product labeled by Leading Pharma, LLC, priced at $0.3371 per EA under NDC 69315040256. 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
.5 mg/561
Manufacturer
Leading Pharma, LLCNDC
69315040256
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 0.5 MG TABLET has been published 131 times since Dec 13, 2023, and over the history we have for it it has declined 91.8%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.3371 per EA |
|---|---|
| All-time high | $4.0939 (Dec 13, 2023) |
| All-time low | $0.3293 (Apr 22, 2026) |
| 52-week high | $0.5253 |
| 52-week low | $0.3293 |
| Median price | $0.6725 |
| Average price | $0.9946 |
| Largest weekly change | -53.1% (Jul 17, 2024) |
| Weeks tracked | 131 |
| Tracking since | Dec 13, 2023 |
1W
N/A
1M
N/A
3M
0.0%
6M
-0.5%
1Y
-35.8%
3Y
N/A
5Y
N/A
All
-91.8%
Last surveyed Jun 10, 2026 — this NDC no longer appears in the current weekly NADAC file.
Generic Alternatives
No other NADAC-published product shares this drug's active ingredient and strength in a comparable dosage form. Compare the broader picture on the VARENICLINE TARTRATE market page.
Lowest-Cost Alternatives
No alternatives available
Related Drugs
Same classification
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 Leading Pharma, LLC, is $0.3371 per EA (NDC 69315040256), effective Jun 10, 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 91.8%. It has been tracked across 131 weekly CMS publications since Dec 13, 2023.
What are the highest and lowest recorded NADAC prices for VARENICLINE 0.5 MG TABLET?
Since Dec 13, 2023, the NADAC for VARENICLINE 0.5 MG TABLET has ranged from a low of $0.3293 (Apr 22, 2026) to a high of $4.0939 (Dec 13, 2023), with a median of $0.6725 per EA.
Are there cheaper alternatives to VARENICLINE 0.5 MG TABLET?
No other NADAC-published product currently shares the active ingredient and strength of VARENICLINE 0.5 MG TABLET in a comparable dosage form, so no direct lower-cost alternative is listed.
Who manufactures VARENICLINE 0.5 MG TABLET?
VARENICLINE 0.5 MG TABLET (NDC 69315040256) is labeled by Leading Pharma, LLC, and CMS classifies it as a generic product.