Product Information
VARENICLINE 0.5 MG TABLET is a generic product labeled by Zydus Pharmaceuticals (USA) Inc., priced at $0.3364 per EA under NDC 70710161306. Its NADAC has been published 163 times since Jul 12, 2023.
FDA first approved this application on Jun 12, 2023. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
.5 mg/1
Manufacturer
Zydus Pharmaceuticals (USA) Inc.NDC
70710161306
Classification
Generic
Dosage Form
TABLET, FILM COATED
Route
ORAL
Effective Date
8/19/2026
Active Ingredients
VARENICLINE TARTRATEApproval Type
Generic (ANDA)
FDA Application
ANDA216723FDA Approved
6/12/2023
TE Code
AB
On Market Since
6/13/2023
Pharmacological Classes
Price Statistics
The NADAC for VARENICLINE 0.5 MG TABLET has been published 163 times since Jul 12, 2023, and over the history we have for it it has declined 94.3%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.3364 per EA |
|---|---|
| All-time high | $6.1398 (Aug 16, 2023) |
| All-time low | $0.3191 (Jun 17, 2026) |
| 52-week high | $0.5253 |
| 52-week low | $0.3191 |
| Median price | $0.6989 |
| Average price | $1.4922 |
| Largest weekly change | -53.1% (Jul 17, 2024) |
| Weeks tracked | 163 |
| Tracking since | Jul 12, 2023 |
Generic Alternatives
The matcher finds 2 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). Switching to the cheapest would cut per-unit acquisition cost by roughly 2% at current NADAC. 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 0.5 MG TABLET?
The current National Average Drug Acquisition Cost (NADAC) for VARENICLINE 0.5 MG TABLET, manufactured by Zydus Pharmaceuticals (USA) Inc., is $0.3364 per EA (NDC 70710161306), 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 94.3%. It has been tracked across 163 weekly CMS publications since Jul 12, 2023.
What are the highest and lowest recorded NADAC prices for VARENICLINE 0.5 MG TABLET?
Since Jul 12, 2023, the NADAC for VARENICLINE 0.5 MG TABLET has ranged from a low of $0.3191 (Jun 17, 2026) to a high of $6.1398 (Aug 16, 2023), with a median of $0.6989 per EA.
Are there cheaper alternatives to VARENICLINE 0.5 MG TABLET?
Yes. 2 manufacturers publish a NADAC-priced product with the same active ingredient and strength in a comparable dosage form. The lowest-priced option, VARENICLINE 0.5 MG TABLET, is $0.3293 per EA — about 2% below VARENICLINE 0.5 MG TABLET.
Who manufactures VARENICLINE 0.5 MG TABLET?
VARENICLINE 0.5 MG TABLET (NDC 70710161306) is labeled by Zydus Pharmaceuticals (USA) Inc., and CMS classifies it as a generic product.