Product Information
VARENICLINE 0.5 MG TABLET is a generic product labeled by Major Pharmaceuticals, priced at $0.3364 per EA under NDC 00904741335. Its NADAC has been published 135 times since Jan 24, 2024.
FDA first approved this application on Aug 23, 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
Major PharmaceuticalsNDC
00904741335
Classification
Generic
Dosage Form
TABLET, FILM COATED
Route
ORAL
Effective Date
8/19/2026
Active Ingredients
VARENICLINE TARTRATEApproval Type
Generic (ANDA)
FDA Application
ANDA214557FDA Approved
8/23/2023
TE Code
AB
On Market Since
12/18/2023
Pharmacological Classes
Price Statistics
The NADAC for VARENICLINE 0.5 MG TABLET has been published 135 times since Jan 24, 2024, and over the history we have for it it has declined 86.3%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.3364 per EA |
|---|---|
| All-time high | $3.2738 (Apr 10, 2024) |
| All-time low | $0.3191 (Jun 17, 2026) |
| 52-week high | $0.5253 |
| 52-week low | $0.3191 |
| Median price | $0.6393 |
| Average price | $0.8426 |
| Largest weekly change | -53.1% (Jul 17, 2024) |
| Weeks tracked | 135 |
| Tracking since | Jan 24, 2024 |
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
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 Major Pharmaceuticals, is $0.3364 per EA (NDC 00904741335), 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 86.3%. It has been tracked across 135 weekly CMS publications since Jan 24, 2024.
What are the highest and lowest recorded NADAC prices for VARENICLINE 0.5 MG TABLET?
Since Jan 24, 2024, the NADAC for VARENICLINE 0.5 MG TABLET has ranged from a low of $0.3191 (Jun 17, 2026) to a high of $3.2738 (Apr 10, 2024), with a median of $0.6393 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 00904741335) is labeled by Major Pharmaceuticals, and CMS classifies it as a generic product.