Product Information
VARENICLINE 0.5 MG TABLET is a generic product labeled by Macleods Pharmaceuticals Limited, priced at $0.3364 per EA under NDC 33342048919. Its NADAC has been published 51 times since Sep 3, 2025.
FDA first approved this application on Dec 9, 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
Macleods Pharmaceuticals LimitedNDC
33342048919
Classification
Generic
Dosage Form
TABLET, FILM COATED
Route
ORAL
Effective Date
8/19/2026
Active Ingredients
VARENICLINE TARTRATEApproval Type
Generic (ANDA)
FDA Application
ANDA215048FDA Approved
12/9/2024
TE Code
AB
On Market Since
12/10/2024
Pharmacological Classes
Price Statistics
The NADAC for VARENICLINE 0.5 MG TABLET has been published 51 times since Sep 3, 2025, and over the history we have for it it has declined 36.0%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.3364 per EA |
|---|---|
| All-time high | $0.5253 (Sep 10, 2025) |
| All-time low | $0.3191 (Jun 17, 2026) |
| 52-week high | $0.5253 |
| 52-week low | $0.3191 |
| Median price | $0.3463 |
| Average price | $0.3699 |
| Largest weekly change | +18.1% (Jul 22, 2026) |
| Weeks tracked | 51 |
| Tracking since | Sep 3, 2025 |
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 Macleods Pharmaceuticals Limited, is $0.3364 per EA (NDC 33342048919), 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 36.0%. It has been tracked across 51 weekly CMS publications since Sep 3, 2025.
What are the highest and lowest recorded NADAC prices for VARENICLINE 0.5 MG TABLET?
Since Sep 3, 2025, the NADAC for VARENICLINE 0.5 MG TABLET has ranged from a low of $0.3191 (Jun 17, 2026) to a high of $0.5253 (Sep 10, 2025), with a median of $0.3463 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 33342048919) is labeled by Macleods Pharmaceuticals Limited, and CMS classifies it as a generic product.