Quick answers
- What is Ranolazine used for?
- The FDA-approved label (Aspruzyo Sprinkle, Sun Pharmaceutical Industries, Inc., January 29, 2025) says: “ASPRUZYO Sprinkle is indicated for the treatment of chronic angina. ASPRUZYO Sprinkle may be used with beta-blockers, nitrates, calcium channel blockers, anti‑platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. ASPRUZYO Sprinkle is an antianginal indicated for the treatment of chronic angina.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ranolazine have a boxed warning?
- No. None of the 29 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ranolazine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ranolazine been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started September 17, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ranolazine?
- 28 companies list prescription products of Ranolazine in the FDA NDC Directory, including Proficient Rx LP, Bryant Ranch Prepack and Viona Pharmaceuticals Inc.
What Ranolazine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ASPRUZYO Sprinkle is indicated for the treatment of chronic angina. ASPRUZYO Sprinkle may be used with beta-blockers, nitrates, calcium channel blockers, anti‑platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. ASPRUZYO Sprinkle is an antianginal indicated for the treatment of chronic angina.
— FDA label: Aspruzyo Sprinkle, Sun Pharmaceutical Industries, Inc., effective January 29, 2025. Read the full label on DailyMed →
The FDA has 29 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 29 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated, extended release · Tablet, extended release · Granule |
|---|---|
| Route | Oral |
| Prescription products | 53 in the FDA NDC Directory |
| Brand names | Aspruzyo Sprinkle |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ranolazine 1000 mg tablet, extended release | Generic | $0.2747 per tablet |
| ranolazine 1000 mg tablet, film coated, extended release | Generic | $0.2747 per tablet |
| ranolazine 500 mg tablet, extended release | Generic | $0.1664 per tablet |
| ranolazine 500 mg tablet, film coated, extended release | Generic | $0.1664 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Proficient Rx LP3 products
- Bryant Ranch Prepack2 products
- Viona Pharmaceuticals Inc2 products
- Unichem Pharmaceuticals (USA), Inc.2 products
- Aurobindo Pharma Limited2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- i3 Pharmaceuticals, LLC2 products
- Radha Pharmaceuticals, Inc.2 products
- AvKARE2 products
- Ascend Laboratories, LLC2 products
- Westminster Pharmaceuticals, LLC2 products
- Lifestar Pharma LLC2 products
- Lupin Pharmaceuticals, Inc.2 products
- Ajanta Pharma USA Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Zydus Lifesciences Limited2 products
- A2A Integrated Pharmaceuticals2 products
- AvPAK2 products
- SunGen Pharma LLC2 products
- ScieGen Pharmaceuticals, Inc.2 products
- Umedica Laboratories USA Inc.2 products
- Zameer Pharmaceuticals LLC2 products
- Torrent Pharma, Inc.2 products
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Major Pharmaceuticals1 product
- American Health Packaging1 product
- Sun Pharmaceutical Industries, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA216018 ASPRUZYO SPRINKLE | Spil | February 28, 2022 | — |
Generic approvals (15)
- ANDA201046Chartwell Rx · July 29, 2013
- ANDA210054Ajanta Pharma Ltd · May 28, 2019
- ANDA211829Sciegen Pharms · June 4, 2019
- ANDA211082Glenmark Pharms Ltd · July 5, 2019
- ANDA210188Cadila · August 19, 2019
- ANDA212284Mankind Pharma · February 12, 2020
- ANDA212781Quagen · March 23, 2020
- ANDA209953Alkem Labs Ltd · November 30, 2020
- ANDA214035Vkt Pharma · January 19, 2022
- ANDA213517Pharmazone · April 27, 2022
- ANDA212788Hetero Labs Ltd III · May 5, 2022
- ANDA209081Aurobindo Pharma · December 23, 2022
- ANDA213083Unichem · March 16, 2023
- ANDA213085Piramal · July 25, 2023
- ANDA214551Umedica · August 5, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 17, 2026 · Class II · Ongoing · D-0010-2027
Failed Dissolution Specifications: below specification
Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02 — Ajanta Pharma USA Inc
-
March 13, 2025 · Class II · Ongoing · D-0335-2025
CGMP Deviations
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwa — Glenmark Pharmaceuticals Inc., USA
-
October 23, 2023 · Class II · Ongoing · D-0092-2024
Failed Dissolution Specifications: Out of specification for dissolution.
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, M — Glenmark Pharmaceuticals Inc., USA
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Aspruzyo Sprinkle, Sun Pharmaceutical Industries, Inc., effective January 29, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →