DrugDashboards

Leflunomide

Leflunomide · LEFLUNOMIDE 10 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited

NDC 46708-0436-30 · 30 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

9 companies supply this market — a reasonable cushion if one runs into trouble.

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 60505-2502-01) — 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
$0.5673per unit
middle half $0.4324$1.37 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $0.5673
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 2 · prior auth 0% · step therapy 0% · qty limit 66%

*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 10 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
ANDA091369
TE code
AB
Approval date
Nov 21, 2011
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Leflunomide (Tablet)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackLEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackLEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 3, 2026
Alembic Pharmaceuticals Inc.LEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.LEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedLEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedLEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.LEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.LEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
AvKARELEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
AvKARELEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
AvPAKLEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
AvPAKLEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCLEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCLEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.LEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.LEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
KVK-Tech, Inc.LEFLUNOMIDE 10 mg/1Jul 15, 2026Sep 2, 2026
KVK-Tech, Inc.LEFLUNOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Leflunomide — NDC 46708-0436-30," retrieved September 3, 2026, https://drugdashboards.com/drug/46708043630.

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