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Ranolazine

Ranolazine · RANOLAZINE 500 mg/1 · Tablet, Film Coated, Extended Release · Oral · Glenmark Pharmaceuticals Inc., USA

NDC 68462-0319-05 · 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

20 companies supply this market — deep enough that no single failure threatens the supply. One of its named manufacturing plants, Glenmark Pharmaceuticals Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

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
ANDA211082
TE code
AB
Approval date
Jul 5, 2019
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingMar 13, 2025
    Glenmark Pharmaceuticals Inc., USA — CGMP Deviations
  • Class II · OngoingOct 23, 2023
    Glenmark Pharmaceuticals Inc., USA — Failed Dissolution Specifications: Out of specification for dissolution.

Manufacturers of Ranolazine (Tablet, Film Coated, Extended Release)

LabelerStrengthFirst seenLast seen
Aphena Pharma Solutions - Tennessee, LLCRANOLAZINE 500 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedRANOLAZINE 1000 mg/1Jul 15, 2026Sep 3, 2026
Proficient Rx LPRANOLAZINE 500 mg/1Jul 15, 2026Sep 3, 2026
A2A Integrated PharmaceuticalsRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
A2A Integrated PharmaceuticalsRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
AvKARERANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
AvKARERANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
AvPAKRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
AvPAKRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.RANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.RANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USARANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USARANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
i3 Pharmaceuticals, LLCRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
i3 Pharmaceuticals, LLCRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
Lifestar Pharma LLCRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
Lifestar Pharma LLCRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
Radha Pharmaceuticals, IncRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Radha Pharmaceuticals, IncRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
ScieGen Pharmaceuticals, IncRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
ScieGen Pharmaceuticals, IncRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
SunGen Pharma LLCRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
SunGen Pharma LLCRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Torrent Pharma, Inc.RANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Torrent Pharma, Inc.RANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.RANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.RANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Westminster Pharmaceuticals, LLCRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026
Westminster Pharmaceuticals, LLCRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Zameer Pharmaceuticals LLCRANOLAZINE 500 mg/1Jul 15, 2026Sep 2, 2026
Zameer Pharmaceuticals LLCRANOLAZINE 1000 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Ranolazine — NDC 68462-0319-05," retrieved September 3, 2026, https://drugdashboards.com/drug/68462031905.

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