DrugDashboards

Fenofibric Acid

Fenofibric Acid · FENOFIBRIC ACID 135 mg/1 · Capsule, Delayed Release · Fournier Laboratories Ireland LTD

NDC 68543-3162-01 · 57000 CAPSULE, DELAYED RELEASE in 1 DRUM · DRUG FOR FURTHER PROCESSING · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 59651-0217-90) — 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
$0.5656per unit
middle half $0.3884$0.8008 · 3,639 plans · Apr 1, 2026
Est. net of rebates
≈ $0.5656
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
66%of plans cover it
tier 3 · prior auth 0% · step therapy 0% · qty limit 13%

*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 1 quarter 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)

0.1%chance of a new FDA shortage posting for fenofibric acid (oral solid) in the next 90 days

sole-source market · price up 7% YoY

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 →

Regulatory

Application
TE code
Approval date
Patents / exclusivity

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Fenofibric Acid (Capsule, Delayed Release)

LabelerStrengthFirst seenLast seen
Amneal Pharmaceuticals of New York LLCFENOFIBRIC ACID 135 mg/1Jul 15, 2026Sep 3, 2026
Alembic Pharmaceuticals Inc.FENOFIBRIC ACID 135 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.FENOFIBRIC ACID 45 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedFENOFIBRIC ACID 45 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedFENOFIBRIC ACID 135 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedFENOFIBRIC ACID 45 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedFENOFIBRIC ACID 135 mg/1Jul 15, 2026Sep 2, 2026
Fournier Laboratories Ireland LTDFENOFIBRIC ACID 135 mg/1Jul 15, 2026Sep 2, 2026
Fournier Laboratories Ireland LTDFENOFIBRIC ACID 45 mg/1Jul 15, 2026Sep 2, 2026
Laurus Labs LimitedFENOFIBRIC ACID 135 mg/1Jul 15, 2026Sep 2, 2026
Laurus Labs LimitedFENOFIBRIC ACID 45 mg/1Jul 15, 2026Sep 2, 2026
Leading Pharma, LLCFENOFIBRIC ACID 45 mg/1Jul 15, 2026Sep 2, 2026
Leading Pharma, LLCFENOFIBRIC ACID 135 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedCHOLINE FENOFIBRATE 45 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedCHOLINE FENOFIBRATE 135 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCFENOFIBRIC ACID 45 mg/1Jul 15, 2026Aug 29, 2026
Micro Labs LimitedFENOFIBRIC ACID 45 mg/1Jul 15, 2026Aug 5, 2026
Micro Labs LimitedFENOFIBRIC ACID 135 mg/1Jul 15, 2026Aug 5, 2026

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

Cite this page

DrugDashboards, "Fenofibric Acid — NDC 68543-3162-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68543316201.

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