Product Information
LEFLUNOMIDE 10 MG TABLET is a generic product labeled by Burel Pharmaceuticals, LLC, priced at $0.3247 per EA under NDC 35573044730. Its NADAC has been published 213 times since Jul 27, 2022.
FDA first approved this application on May 10, 2021. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
10 mg/1
Manufacturer
Burel Pharmaceuticals, LLCNDC
35573044730
Classification
Generic
Dosage Form
TABLET, FILM COATED
Route
ORAL
Effective Date
8/19/2026
Active Ingredients
LEFLUNOMIDEApproval Type
Generic (ANDA)
FDA Application
ANDA213497FDA Approved
5/10/2021
TE Code
AB
On Market Since
1/3/2022
Pharmacological Classes
Price Statistics
The NADAC for LEFLUNOMIDE 10 MG TABLET has been published 213 times since Jul 27, 2022, and over the history we have for it it has declined 33.8%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.3247 per EA |
|---|---|
| All-time high | $0.5344 (Oct 12, 2022) |
| All-time low | $0.2670 (Nov 20, 2024) |
| 52-week high | $0.3574 |
| 52-week low | $0.3023 |
| Median price | $0.3574 |
| Average price | $0.3769 |
| Largest weekly change | +37.2% (May 17, 2023) |
| Weeks tracked | 213 |
| Tracking since | Jul 27, 2022 |
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 LEFLUNOMIDE 10 MG TABLET?
The current National Average Drug Acquisition Cost (NADAC) for LEFLUNOMIDE 10 MG TABLET, manufactured by Burel Pharmaceuticals, LLC, is $0.3247 per EA (NDC 35573044730), effective Aug 19, 2026.
How has the price of LEFLUNOMIDE 10 MG TABLET changed over time?
Over the history we have for it, the NADAC for LEFLUNOMIDE 10 MG TABLET has declined 33.8%. It has been tracked across 213 weekly CMS publications since Jul 27, 2022.
What are the highest and lowest recorded NADAC prices for LEFLUNOMIDE 10 MG TABLET?
Since Jul 27, 2022, the NADAC for LEFLUNOMIDE 10 MG TABLET has ranged from a low of $0.2670 (Nov 20, 2024) to a high of $0.5344 (Oct 12, 2022), with a median of $0.3574 per EA.
Are there cheaper alternatives to LEFLUNOMIDE 10 MG TABLET?
2 manufacturers publish a NADAC-priced product with the same active ingredient and strength as LEFLUNOMIDE 10 MG TABLET in a comparable dosage form, but none are currently priced below it.
Who manufactures LEFLUNOMIDE 10 MG TABLET?
LEFLUNOMIDE 10 MG TABLET (NDC 35573044730) is labeled by Burel Pharmaceuticals, LLC, and CMS classifies it as a generic product.