Product Information
VARENICLINE 0.5 MG TABLET is a generic product labeled by Mylan Pharmaceuticals Inc., priced at $0.3293 per EA under NDC 00378508973. Its NADAC has been published 91 times since Aug 7, 2024.
FDA first approved this application on Feb 28, 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
Mylan Pharmaceuticals Inc.NDC
00378508973
Classification
Generic
Dosage Form
TABLET, FILM COATED
Route
ORAL
Effective Date
4/22/2026
Active Ingredients
VARENICLINE TARTRATEApproval Type
Generic (ANDA)
FDA Application
ANDA202019FDA Approved
2/28/2024
TE Code
AB
On Market Since
3/14/2024
Pharmacological Classes
Price Statistics
The NADAC for VARENICLINE 0.5 MG TABLET has been published 91 times since Aug 7, 2024, and over the history we have for it it has declined 46.4%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.3293 per EA |
|---|---|
| All-time high | $1.1382 (Oct 16, 2024) |
| All-time low | $0.3293 (Apr 22, 2026) |
| 52-week high | $0.5253 |
| 52-week low | $0.3293 |
| Median price | $0.6139 |
| Average price | $0.6008 |
| Largest weekly change | -43.2% (Nov 20, 2024) |
| Weeks tracked | 91 |
| Tracking since | Aug 7, 2024 |
1W
N/A
1M
N/A
3M
N/A
6M
-2.8%
1Y
-37.3%
3Y
N/A
5Y
N/A
All
-46.4%
Last surveyed Apr 29, 2026 — this NDC no longer appears in the current weekly NADAC file.
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). 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
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 Mylan Pharmaceuticals Inc., is $0.3293 per EA (NDC 00378508973), effective Apr 29, 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 46.4%. It has been tracked across 91 weekly CMS publications since Aug 7, 2024.
What are the highest and lowest recorded NADAC prices for VARENICLINE 0.5 MG TABLET?
Since Aug 7, 2024, the NADAC for VARENICLINE 0.5 MG TABLET has ranged from a low of $0.3293 (Apr 22, 2026) to a high of $1.1382 (Oct 16, 2024), with a median of $0.6139 per EA.
Are there cheaper alternatives to VARENICLINE 0.5 MG TABLET?
2 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 00378508973) is labeled by Mylan Pharmaceuticals Inc., and CMS classifies it as a generic product.