Product Information
VARENICLINE 0.5 MG TABLET is a generic product labeled by Dr. Reddy's Laboratories Inc., priced at $0.3116 per EA under NDC 43598090756. Its NADAC has been published 65 times since Jul 9, 2025.
FDA first approved this application on Oct 1, 2024. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
.5 mg/1
Manufacturer
Dr. Reddy's Laboratories Inc.NDC
43598090756
Classification
Generic
Dosage Form
TABLET, FILM COATED
Route
ORAL
Effective Date
9/23/2026
Active Ingredients
VARENICLINE TARTRATEApproval Type
Generic (ANDA)
FDA Application
ANDA215931FDA Approved
10/1/2024
TE Code
AB
On Market Since
12/13/2024
Pharmacological Classes
Price Statistics
The NADAC for VARENICLINE 0.5 MG TABLET has been published 65 times since Jul 9, 2025, and over the history we have for it it has declined 55.4%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.3116 per EA |
|---|---|
| All-time high | $0.6989 (Jul 16, 2025) |
| All-time low | $0.3116 (Sep 23, 2026) |
| 52-week high | $0.4562 |
| 52-week low | $0.3116 |
| Median price | $0.3463 |
| Average price | $0.3975 |
| Largest weekly change | +18.1% (Jul 22, 2026) |
| Weeks tracked | 65 |
| Tracking since | Jul 9, 2025 |
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
Dr. Reddy's Laboratories 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 Dr. Reddy's Laboratories Inc., is $0.3116 per EA (NDC 43598090756), 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 55.4%. It has been tracked across 65 weekly CMS publications since Jul 9, 2025.
What are the highest and lowest recorded NADAC prices for VARENICLINE 0.5 MG TABLET?
Since Jul 9, 2025, the NADAC for VARENICLINE 0.5 MG TABLET has ranged from a low of $0.3116 (Sep 23, 2026) to a high of $0.6989 (Jul 16, 2025), with a median of $0.3463 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 43598090756) is labeled by Dr. Reddy's Laboratories Inc., and CMS classifies it as a generic product.