DrugDashboards

leflunomide

leflunomide · LEFLUNOMIDE 10 mg/1 · Tablet, Film Coated · Oral · Zydus Pharmaceuticals (USA) Inc.

NDC 70710-1157-01 · 100 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

10 companies supply this market — deep enough that no single failure threatens the supply.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00088-2160-30) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$47.12per unit
middle half $47.12$47.12 · 2 plans · Jul 1, 2024
Est. net of rebates
≈ $47.12
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
of plans cover it

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 3 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for leflunomide (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA212308
TE code
AB
Approval date
Apr 24, 2019
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation Arava, Tablet, 10 mg (NDC 0088-2160-30)Jun 8, 2026
  • Planned discontinuation Arava, Tablet, 100 mg (NDC 0088-2162-33)Jun 8, 2026
  • Planned discontinuation Arava, Tablet, 20 mg (NDC 0088-2161-30)Jun 8, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of leflunomide (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsLEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedLEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedLEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackLEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Burel Pharmaceuticals, LLCLEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Burel Pharmaceuticals, LLCLEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.LEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.LEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals, Inc.LEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals, Inc.LEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Opella Healthcare International SasLEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Opella Healthcare International SasLEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
sanofi-aventis U.S. LLCLEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
sanofi-aventis U.S. LLCLEFLUNOMIDE 100 mg/1Jul 15, 2026Sep 2, 2026
sanofi-aventis U.S. LLCLEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedLEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedLEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals (USA) Inc.LEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals (USA) Inc.LEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackLEFLUNOMIDE 20 mg/1Jul 15, 2026Aug 28, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "leflunomide — NDC 70710-1157-01," retrieved September 3, 2026, https://drugdashboards.com/drug/70710115701.

Free to cite with attribution — see how the data is put together.