DrugDashboards

Ranolazine

Ranolazine · RANOLAZINE 1000 mg/1 · Tablet, Extended Release · Oral · Viona Pharmaceuticals Inc

NDC 72578-0065-01 · 100 TABLET, EXTENDED RELEASE 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 27241-0126-02) — 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
$0.7899per unit
middle half $0.4798$1.21 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $0.7899
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 3 · prior auth 0% · step therapy 0% · qty limit 58%

*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 ranolazine (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
ANDA210188
TE code
AB
Approval date
Aug 19, 2019
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 Ranolazine (Tablet, Extended Release)

LabelerStrengthFirst seenLast seen
Ajanta Pharma USA Inc.RANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
Ajanta Pharma USA Inc.RANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
NCS HealthCare of KY, LLC dba Vangard LabsRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.RANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.RANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
Umedica Laboratories USA Inc.RANOLAZINE 1000 mg/1Aug 12, 2026Sep 2, 2026
Umedica Laboratories USA Inc.RANOLAZINE 500 mg/1Aug 12, 2026Sep 2, 2026
Viona Pharmaceuticals IncRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
Viona Pharmaceuticals IncRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
Micro Labs LimitedRANOLAZINE 1000 mg/1Jul 15, 2026Aug 5, 2026
Micro Labs LimitedRANOLAZINE 500 mg/1Jul 15, 2026Aug 5, 2026

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

Cite this page

DrugDashboards, "Ranolazine — NDC 72578-0065-01," retrieved September 3, 2026, https://drugdashboards.com/drug/72578006501.

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