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Ranolazine

Ranolazine is an antianginal medicine used to treat chronic angina (long-lasting chest pain from reduced blood flow to the heart), available as extended-release tablets and as an oral granule product.

Brand names RanexaAspruzyoAspruzyo Sprinkle
Drug class Anti-anginal
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 33 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record · 2
Ranolazine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Ranolazine is a twice-daily add-on for chronic angina (chest pain from poor blood flow to the heart), usually started when standard angina medicines fall short, and unlike those it barely lowers heart rate or blood pressure; it has been around since about 2006 and is available generically. It is usually well tolerated; dizziness, constipation, nausea and headache are what people notice most. The catch is interactions, since some antibiotics, antifungals, seizure medicines and grapefruit raise or lower its levels, and high levels can lengthen the QT interval (a heart rhythm measure), so clear any new medicine or supplement with your pharmacist and get help fast for fainting or racing heartbeat.

Clinical pearls

  • Swallow the extended-release tablets whole, never crushed, broken or chewed; Aspruzyo Sprinkle granules go on applesauce or yogurt.
  • Avoid grapefruit products, which push ranolazine levels up, and St. John’s wort, which sharply lowers them.
  • Your simvastatin dose gets capped, and metformin or digoxin may need lowering, with blood sugar checks for metformin.
  • It is not for anyone with liver cirrhosis, and moderate to severe kidney problems call for periodic kidney function checks.
How you get itPrescription only
Comes asExtended-release tablet, Oral powder
Earliest FDA record2006
Companies listing it with the FDA28
FDA label last updatedJan 29, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Ranolazine, written from its FDA label.

What Ranolazine is used for

▾

Ranolazine is approved for one condition across its products.

  • Chronic angina: Ranolazine extended-release tablets and Aspruzyo Sprinkle (oral granules) are each indicated for it.
  • Either product may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.

How Ranolazine works

▾

Ranolazine has anti-ischemic and antianginal effects. These do not depend on lowering heart rate or blood pressure.

At therapeutic levels it can block the cardiac late sodium current. The label says the link between this and angina relief is uncertain, and the exact mechanism has not been determined.

Ranolazine dosage

▾

Ranolazine is taken by mouth twice a day. Prescribers usually start at a lower dose and increase it if needed, based on symptoms. Follow your prescriber and the label.

  • Extended-release tablets: with or without food, swallowed whole, never crushed, broken or chewed.
  • Aspruzyo Sprinkle: granules sprinkled on soft food and eaten right away, without crushing or chewing. It can also be given through an NG or G tube as the label describes.
  • Missed dose: take the next one at the regular time. Do not double.

Dosing details from the FDA-approved label

From the Ranolazine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • General dosing (Ranolazine; Aspruzyo Sprinkle granules and extended-release tablets)
    • Initiate at 500 mg twice daily and increase to 1000 mg twice daily, as needed, based on clinical symptoms
    • Missed dose: take the prescribed dose at the next scheduled time
    • Do not double the next dose
    • Maximum: 1000 mg twice daily
    • Tablets: take with or without meals; swallow whole, do not crush, break, or chew. Aspruzyo granules: sprinkle on one tablespoonful of soft food and consume immediately; do not crush or chew the granules.
  • Patients on moderate CYP3A inhibitors (such as diltiazem, verapamil, and erythromycin)
    • Limit the maximum dose to 500 mg twice daily
    • Maximum: 500 mg twice daily
  • Patients on P-gp inhibitors (such as cyclosporine) (tablet labels)
    • Titrate based on clinical response
    • P-gp inhibitors may increase exposure
  • Aspruzyo Sprinkle via nasogastric (NG) tube
    • Add the content of a sachet to a plastic catheter tip syringe with 50 mL of water, gently shake for approximately 15 seconds, and promptly deliver through a 12 French or larger NG tube
    • Rinse with additional water (about 15 mL) if needed
    • Ensure no granules are left in the syringe
  • Aspruzyo Sprinkle via gastrostomy/gastric (G) tube
    • Add the content of a sachet to a plastic catheter tip syringe with 30 mL of water, gently shake for approximately 15 seconds, and promptly deliver through a 12 French or larger G-tube
    • Rinse with 20 mL of water in the syringe, and additional water (about 15 mL) if needed
    • Ensure no granules are left in the syringe
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 500 mg twice daily and increase to 1000 mg twice daily, based on clinical symptoms ( 2.1 ) 2.1 Dosing Information Initiate Ranolazine Extended-Release Tablets dosing at 500 mg twice daily and increase to 1000 mg twice daily, as needed, based on clinical symptoms. Take Ranolazine Extended-Release Tablets with or without meals. Swallow Ranolazine Extended-Release Tablets whole; do not crush, break, or chew. The maximum recommended daily dose of Ranolazine Extended-Release Tablets is 1000 mg twice daily. If a dose of Ranolazine Extended-Release Tablets is missed, take the prescribed dose at the next scheduled time; do not double the next dose. 2.2 Dose Modification Dose adjustments may be needed when Ranolazine Extended-Release Tablets is taken in combination with certain other drugs [see Drug Interactions (7.1) ]. Limit the maximum dose of Ranolazine Extended-Release Tablets to 500 mg twice daily in patients on moderate CYP3A inhibitors such as diltiazem, verapamil, and erythromycin. Use of Ranolazine Extended-Release Tablets with strong CYP3A inhibitors is contraindicated [see Contraindications (4) , Drug Interactions (7.1) ]. Use of P-gp inhibitors, such as cyclosporine, may increase exposure to Ranolazine Extended-Release Tablets. Titrate Ranolazine Extended-Release Tablets based on clinical response [see Drug Interactions (7.1) ].

2.1 Dosing Information Initiate Ranolazine Extended-Release Tablets dosing at 500 mg twice daily and increase to 1000 mg twice daily, as needed, based on clinical symptoms. Take Ranolazine Extended-Release Tablets with or without meals. Swallow Ranolazine Extended-Release Tablets whole; do not crush, break, or chew. The maximum recommended daily dose of Ranolazine Extended-Release Tablets is 1000 mg twice daily. If a dose of Ranolazine Extended-Release Tablets is missed, take the prescribed dose at the next scheduled time; do not double the next dose.

2.2 Dose Modification Dose adjustments may be needed when Ranolazine Extended-Release Tablets is taken in combination with certain other drugs [see Drug Interactions (7.1) ]. Limit the maximum dose of Ranolazine Extended-Release Tablets to 500 mg twice daily in patients on moderate CYP3A inhibitors such as diltiazem, verapamil, and erythromycin.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Ranolazine side effects

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The most common side effects in studies were:

Common side effects

  • Dizziness
  • Headache
  • Constipation
  • Nausea
  • Weakness (asthenia)
  • Dry mouth
  • Vomiting
  • Abdominal pain

When to get medical help

  • Fainting, a racing or irregular heartbeat, or palpitations, which can signal a heart rhythm (QT) problem. Get help right away.
  • Very slow heartbeat or low blood pressure, such as feeling faint when standing up.
  • Confusion or hallucinations.
  • Much less urination or other signs of kidney trouble, especially if you already have severe kidney problems.
  • Blood in the urine.
  • Severe tremor, muscle jerks, or unsteady walking, which can happen with overdose. Seek emergency care.

Less common effects included weakness, dry mouth, vomiting, palpitations, slow heartbeat, and low blood pressure. Call your doctor about fainting, a pounding or irregular heartbeat, confusion, or blood in the urine.

Ranolazine warnings and precautions

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  • QT prolongation: ranolazine can lengthen the QT interval on an ECG. There is little data in people with long QT syndrome or those taking other QT-prolonging drugs.
  • Kidney failure: acute kidney failure has been seen in some people with severe kidney impairment. Kidney function should be monitored if you have moderate to severe impairment.
  • Liver cirrhosis: ranolazine is contraindicated. In cirrhosis, QT prolongation was about three times greater.
  • Doses above the maximum are poorly tolerated.

Ranolazine interactions

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Ranolazine interacts with many medicines because of how it is broken down.

  • Strong CYP3A inhibitors (ketoconazole, clarithromycin, ritonavir): must not be used. They raise ranolazine levels.
  • CYP3A inducers (rifampin, phenytoin, carbamazepine, St. John’s wort): must not be used. They greatly lower levels.
  • Diltiazem, verapamil, erythromycin, fluconazole, grapefruit: dose is capped.
  • Cyclosporine: can raise levels, so the dose is adjusted by response.
  • Simvastatin: dose is limited. Lovastatin, tacrolimus, and sirolimus may need lower doses.
  • Metformin: dose may need a limit, with blood sugar monitoring.
  • Digoxin, tricyclic antidepressants, antipsychotics: may need lower doses.

Interactions listed in the FDA-approved label

From the Ranolazine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A inhibitors (ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir): Use with ranolazine is contraindicated. Do not use ranolazine with strong CYP3A inhibitors.
  • Moderate CYP3A inhibitors (diltiazem, verapamil, erythromycin, fluconazole, grapefruit juice or grapefruit-containing products): Ranolazine dose must be limited when used with these. Limit the dose to 500 mg twice daily.
  • P-gp inhibitors (such as cyclosporine): May result in increases in ranolazine concentrations. Titrate based on clinical response.
  • CYP3A inducers (rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, St. John's wort): Ranolazine should not be used with these inducers. Do not use ranolazine with CYP3A inducers.
  • Simvastatin: Ranolazine may increase simvastatin exposure (CYP3A substrate). Limit simvastatin to 20 mg once daily with any dose of ranolazine.
  • Other sensitive CYP3A substrates (e.g., lovastatin) and narrow-therapeutic-range CYP3A substrates (cyclosporine, tacrolimus, sirolimus): Ranolazine may increase plasma concentrations of these drugs. Dose adjustment of these drugs may be required.
  • Digoxin (drugs transported by P-gp): Concomitant use results in increased exposure to digoxin. The dose of digoxin may have to be adjusted.
  • CYP2D6 substrates (tricyclic antidepressants, antipsychotics): Exposure to these drugs may be increased during co-administration. Lower doses of these drugs may be required.
  • Metformin (OCT2 substrate): With ranolazine 1000 mg twice daily, metformin plasma levels increase in subjects with type 2 diabetes; exposure was not significantly increased with ranolazine 500 mg twice daily. Metformin dose should not exceed 1700 mg/day with ranolazine 1000 mg twice daily; monitor blood glucose levels and risks associated with high metformin exposure.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin): Limit Ranolazine Extended-Release Tablets to 500 mg twice daily. ( 7.1 ) • P-gp inhibitors (e.g., cyclosporine): Ranolazine exposure increased. Titrate Ranolazine Extended-Release Tablets based on clinical response. ( 7.1 ) • CYP3A substrates: Limit simvastatin to 20 mg when used with Ranolazine Extended-Release Tablets. Doses of other sensitive CYP3A substrates (e.g., lovastatin) and CYP3A substrates with narrow therapeutic range (e.g., cyclosporine, tacrolimus, sirolimus) may need to be reduced with Ranolazine Extended-Release Tablets. ( 7.2 ) • OCT2 substrates: Limit the dose of metformin to 1700 mg daily when used with Ranolazine Extended-Release Tablets 1000 mg twice daily. Doses of other OCT2 substrates may require adjusted doses. ( 7.2 ) • Drugs transported by P-gp (e.g., digoxin), or drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants) may need reduced doses when used with Ranolazine Extended-Release Tablets. ( 7.2 ) See 17 for PATIENT COUNSELING INFORMATION and FDA-Approved Patient Labeling 7.1 Effects of Other Drugs on Ranolazine Strong CYP3A Inhibitors Do not use Ranolazine Extended-Release Tablets with strong CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir [see Contraindications (4) , Clinical Pharmacology (12.3) ]. Moderate CYP3A Inhibitors Limit the dose of Ranolazine Extended-Release Tablets to 500 mg twice daily in patients on moderate CYP3A inhibitors, including diltiazem, verapamil, erythromycin, fluconazole, and grapefruit juice or grapefruit-containing products [see Dosage and Administration (2.2) , Clinical Pharmacology (12.3) ]. P-gp Inhibitors Concomitant use of Ranolazine Extended-Release Tablets and P-gp inhibitors, such as cyclosporine, may result in increases in ranolazine concentrations.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Ranolazine

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  • Do not use with liver cirrhosis.
  • Tell your prescriber about long QT syndrome or other QT-prolonging medicines.
  • Tell your prescriber about moderate to severe kidney problems.
  • Pregnancy: no human data. Animal studies showed no fetal harm at the exposures tested.
  • Breastfeeding: no human data. Discuss benefits and risks with your prescriber.
  • Children: safety and effectiveness have not been established.
  • Older adults: dosing usually starts low. People 75 and older had more adverse events.

Ranolazine overdose

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Overdose of ranolazine tablets has caused low blood pressure, QT prolongation, slow heartbeat, severe tremor, muscle jerks, unsteady walking, dizziness, nausea, vomiting, and hallucinations. Fatal outcomes have been reported with extreme overdose.

Care is supportive, and continuous ECG monitoring may be needed. Dialysis is unlikely to help. Seek emergency help right away if too much is taken.

What Ranolazine does in the body

▾

In studies, ranolazine caused minimal changes in heart rate and blood pressure. It lengthens the QTc interval in a dose- and blood-level-related way, with a wider effect in some people who have higher blood levels. No proarrhythmic effects were seen on 7-day heart monitoring in 3162 acute coronary syndrome patients.

How your body processes Ranolazine

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Ranolazine is broken down extensively in the gut and liver, mainly by CYP3A and less by CYP2D6. Absorption varies a lot from person to person. Steady levels are reached within about 3 days of twice-daily dosing.

Less than 5% leaves the body unchanged. The half-life after a single dose is roughly 5 hours. Age and sex do not change how it behaves.

How to store Ranolazine

▾

Store ranolazine extended-release tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

153

Supplements & herbs that interact with Ranolazine

153 supplements and herbal products have documented interactions with Ranolazine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 8
  • Moderate · 109
  • Minor · 36
Every supplement checked against Ranolazine — ranked by severity The full interaction hub: 8 major · 109 moderate · 36 minor · every one linked to its full report. Check Ranolazine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Ranolazine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Ranolazine — the kind of thing our pharmacy team would talk through with you at the counter.

What is ranolazine for?

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It treats chronic angina, which is recurring chest pain from reduced blood flow to the heart. You can take it along with other heart medicines such as beta-blockers or nitrates. It does not lower your heart rate or blood pressure much.

How should I take it?

▾
Take it by mouth twice a day, as your prescriber directs. Extended-release tablets can be taken with or without food and must be swallowed whole. Aspruzyo Sprinkle granules go on a spoonful of soft food and are eaten right away, without chewing. If you miss a dose, skip it and take the next one on time.

What side effects should I expect?

▾
The most common are dizziness, headache, constipation, and nausea. Tell me or your doctor if they bother you. Call right away if you faint, have a pounding or irregular heartbeat, or become confused.

Can I take it with my other medicines?

▾
Many medicines interact with it, so always check with me first. Some, like ketoconazole, clarithromycin, rifampin, and St. John’s wort, must not be used at all. Others, like diltiazem, verapamil, and simvastatin, need dose limits. Grapefruit juice can also raise ranolazine levels.

Who shouldn’t take ranolazine?

▾
People with liver cirrhosis shouldn’t take it. Tell your prescriber if you have long QT syndrome or kidney problems. If you’re pregnant or breastfeeding, talk it over with your prescriber, since there are no human data.

Is Ranolazine available over the counter?

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No. Ranolazine is a prescription medicine: every Ranolazine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Ranolazine first available?

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The earliest FDA record we hold for Ranolazine is from 2006: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Ranolazine was first used.

Who makes Ranolazine?

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28 companies currently list Ranolazine products in the FDA's NDC Directory, including Proficient Rx LP, Sun Pharmaceutical Industries, Inc., A2A Integrated Pharmaceuticals. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Ranolazine on HelloPharmacist

Detailed data & references for Ranolazine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Ranolazine forms and strengths (how it comes)

Ranolazine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Extended-release tablet

By mouth
Brands Ranexa
How this form is used
What it may be used for
  • Ranolazine extended-release tablets are used to treat chronic angina.
  • Ranolazine extended-release tablets may be used with other angina and heart medicines such as beta-blockers and nitrates.
Important instructions
  • Ranolazine extended-release tablets are taken twice daily, with or without meals.
  • Swallow Ranolazine extended-release tablets whole. Do not crush, break, or chew.
  • If a dose of Ranolazine extended-release tablets is missed, take the next dose at the usual time. Do not double.
Available strengths 2 strengths
93 FDA-listed product records ⓘ

Oral powder

By mouth
Brands Aspruzyo Sprinkle
How this form is used
What it may be used for
  • Aspruzyo Sprinkle is used to treat chronic angina.
  • Aspruzyo Sprinkle may be used with other heart medicines such as beta-blockers and ACE inhibitors.
Important instructions
  • Aspruzyo Sprinkle granules are sprinkled on a tablespoonful of soft food, such as applesauce or yogurt, and eaten right away.
  • Do not crush or chew Aspruzyo Sprinkle granules.
  • Aspruzyo Sprinkle can be given through a nasogastric or gastric tube using water, following the label directions.
Available strengths 1 strength
2 FDA-listed product records ⓘ

Ranolazine on the U.S. market: products, makers and brands

How Ranolazine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

28 companies list 55 Ranolazine product records with the FDA, mostly as extended-release tablet, oral powder; the earliest marketing or approval year on record is 2006. Brand names on the directory include Ranexa, Aspruzyo, Aspruzyo Sprinkle; the rest are generics.

2
Dose forms ⓘ
28
Labelers (makers, repackagers, distributors)
2
Brand names
55
FDA-listed product records ⓘ
2006
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (22) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Proficient Rx LP5%
Sun Pharmaceutical Industries, Inc.5%
A2A Integrated Pharmaceuticals4%
Ajanta Pharma USA Inc.4%
Aphena Pharma Solutions - Tennessee, LLC4%
Ascend Laboratories, LLC4%
Other makers75%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Ranolazine is used (Medicaid data)

A general measure of how commonly Ranolazine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Ranolazine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

134,744
Medicaid prescriptions filled (Q1–Q4 2025)
$4.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ranolazine prescribed? Of the 1,601 medications we measure, Ranolazine ranks #462 by Medicaid prescriptions — more than 71% of them.

Where Ranolazine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Ranolazine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 500 mg 12 hr extended release oral tablet is the most-dispensed Ranolazine product — about 75% of these Medicaid prescriptions.

12 HR ranolazine 500 MG Extended Release Oral Tablet Most dispensed

101,113 Medicaid prescriptions (Q1–Q4 2025) 75% of Ranolazine prescriptions shown $2.7M gross reimbursement (before rebates) ≈ $27 per prescription (gross)

Summed across the 15 of 73 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 616749

12 HR ranolazine 1000 MG Extended Release Oral Tablet

33,631 Medicaid prescriptions (Q1–Q4 2025) 25% of Ranolazine prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $40 per prescription (gross)

Summed across the 12 of 60 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 728231

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ranolazine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 27 of 133 listed Ranolazine NDCs with Medicaid activity.

Compare Ranolazine products

A representative set of FDA-listed product records for Ranolazine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 55 of 55 products — FDA National Drug Code Directory. See every product, package size and price: browse all 55 Ranolazine NDCs →

Ranolazine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 2 Ranolazine recalls since July 2021. Both are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Mar 13, 2025 · Glenmark Pharmaceuticals Inc., USA
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 Pharmaceut… Lots: Lot # 17240040, exp. date Dec-25 FDA record D-0335-2025 →
Ongoing Class II Oct 23, 2023 · Glenmark Pharmaceuticals Inc., USA
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 Prade… Lots: Lot # 17230388, Exp. 01/31/2025 FDA record D-0092-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ranolazine RxCUI 35829 2 dose forms · 4 strengths
  1. Dose form (SCDF) Oral Granules RxCUI 2594752 In current FDA listings
    Clinical drug / strength (SCD) 500 MG RxCUI 2594760 1000 MG RxCUI 2594753

Look up RxCUI 35829 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Ranolazine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated, Extended Release · Oral 500 mg $0.165 per tablet NDC details & price history
Tablet, Extended Release · Oral 1000 mg $0.274 per tablet NDC details & price history
Tablet, Film Coated, Extended Release 500 mg $0.165 per tablet NDC details & price history
Tablet, Film Coated, Extended Release 1000 mg $0.274 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Ranolazine brand names

Ranolazine is sold under 3 brand names in the FDA directory — Ranexa, Aspruzyo, Aspruzyo Sprinkle. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Ranexa Aspruzyo Aspruzyo Sprinkle

Who makes Ranolazine: manufacturers and labelers

28 companies list Ranolazine products with the FDA. By number of product records, the largest are Proficient Rx LP, Sun Pharmaceutical Industries, Inc., A2A Integrated Pharmaceuticals. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Proficient Rx LP 3 Sun Pharmaceutical Industries, Inc. 3 A2A Integrated Pharmaceuticals 2 Ajanta Pharma USA Inc. 2 Aphena Pharma Solutions - Tennessee, LLC 2 Ascend Laboratories, LLC 2 Aurobindo Pharma Limited 2 AvKARE 2 AvPAK 2 Bryant Ranch Prepack 2 Camber Pharmaceuticals, Inc. 2 Glenmark Pharmaceuticals Inc., USA 2 Lifestar Pharma LLC 2 Lupin Pharmaceuticals, Inc. 2 Radha Pharmaceuticals, Inc 2 ScieGen Pharmaceuticals, Inc 2 SunGen Pharma LLC 2 Torrent Pharma, Inc. 2 Umedica Laboratories USA Inc. 2 Unichem Pharmaceuticals (USA), Inc. 2 Viona Pharmaceuticals Inc 2 Westminster Pharmaceuticals, LLC 2 Zameer Pharmaceuticals LLC 2 Zydus Lifesciences Limited 2

…and 4 more on the FDA NDC directory.

Ranolazine drug class (RxNorm)

Ranolazine belongs to the Anti-anginal class.

Pharmacologic class Anti-anginal
Drug family (ATC) Other cardiac preparations
How it works Cytochrome P450 2D6 Inhibitors, P-Glycoprotein Inhibitors, Organic Cation Transporter 2 Inhibitors, Cytochrome P450 3A Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Ranolazine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

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FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 29, 2025
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ranolazine.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ranolazine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
33
Finished products in the current FDA directory
55
Companies listing them (makers, repackagers, distributors)
28
FDA labeler codes behind them ⓘ
31
Linked representative label ⓘ
Sun Pharmaceutical Industries, Inc.
Linked label effective
Jan 29, 2025
Composite sections available
25
Linked SPL Set ID
dd9f81e4-50da-4551-aed5-559d304df42e
Linked SPL Document ID
2cd273e4-313f-3562-e063-6394a90ac135
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sun Pharmaceutical Industries, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →