Product Information
VARENICLINE 0.5 MG TABLET is a generic product labeled by Endo USA Inc., priced at $0.3116 per EA under NDC 49884015576. Its NADAC has been published 241 times since Feb 23, 2022.
FDA first approved this application on Aug 11, 2021. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
.5 mg/1
Manufacturer
Endo USA Inc.NDC
49884015576
Classification
Generic
Dosage Form
TABLET, FILM COATED
Route
ORAL
Effective Date
9/23/2026
Active Ingredients
VARENICLINE TARTRATEApproval Type
Generic (ANDA)
FDA Application
ANDA201785FDA Approved
8/11/2021
TE Code
AB
On Market Since
9/21/2021
Pharmacological Classes
Price Statistics
The NADAC for VARENICLINE 0.5 MG TABLET has been published 241 times since Feb 23, 2022, and over the history we have for it it has declined 95.0%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.3116 per EA |
|---|---|
| All-time high | $6.3231 (Apr 13, 2022) |
| All-time low | $0.3116 (Sep 23, 2026) |
| 52-week high | $0.4562 |
| 52-week low | $0.3116 |
| Median price | $1.3077 |
| Average price | $2.7926 |
| Largest weekly change | -53.1% (Jul 17, 2024) |
| Weeks tracked | 241 |
| Tracking since | Feb 23, 2022 |
Generic Alternatives
The matcher finds 5 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). 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
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Manufacturer
Endo USA Inc. manufacturer profile
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Drug market
varenicline tartrate market comparison
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Therapeutic class
Cholinergic Receptor Agonist class view
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Trend hub
Latest market trends
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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 0.5 MG TABLET?
The current National Average Drug Acquisition Cost (NADAC) for VARENICLINE 0.5 MG TABLET, manufactured by Endo USA Inc., is $0.3116 per EA (NDC 49884015576), effective Sep 30, 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 95.0%. It has been tracked across 241 weekly CMS publications since Feb 23, 2022.
What are the highest and lowest recorded NADAC prices for VARENICLINE 0.5 MG TABLET?
Since Feb 23, 2022, the NADAC for VARENICLINE 0.5 MG TABLET has ranged from a low of $0.3116 (Sep 23, 2026) to a high of $6.3231 (Apr 13, 2022), with a median of $1.3077 per EA.
Are there cheaper alternatives to VARENICLINE 0.5 MG TABLET?
5 manufacturers publish a NADAC-priced product with the same active ingredient and strength as VARENICLINE 0.5 MG TABLET in a comparable dosage form, but none are currently priced below it.
Who manufactures VARENICLINE 0.5 MG TABLET?
VARENICLINE 0.5 MG TABLET (NDC 49884015576) is labeled by Endo USA Inc., and CMS classifies it as a generic product.