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.
🧬 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 →
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.
Patient information guide A plain-language walkthrough of Ranolazine, written from its FDA label.
What Ranolazine is used for
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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
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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
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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
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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
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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 →
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.
- Major · 8
- Moderate · 109
- Minor · 36
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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How should I take it?
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What side effects should I expect?
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Can I take it with my other medicines?
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Who shouldn’t take ranolazine?
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Is Ranolazine available over the counter?
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When was Ranolazine first available?
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Who makes Ranolazine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Ranolazine on HelloPharmacist
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
How this form is used
- 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.
- 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.
Oral powder
How this form is used
- Aspruzyo Sprinkle is used to treat chronic angina.
- Aspruzyo Sprinkle may be used with other heart medicines such as beta-blockers and ACE inhibitors.
- 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.
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.
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.
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.
How commonly is Ranolazine prescribed? Of the 1,601 medications we measure, Ranolazine ranks #462 by Medicaid prescriptions — more than 71% of them.
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.
12 HR ranolazine 500 MG Extended Release Oral Tablet Most dispensed
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
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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Extended-release tablet | ||||
| 500 mg | Oral | A2A Integrated Pharmaceuticals | ANDA | View NDC → |
| 1000 mg | Oral | A2A Integrated Pharmaceuticals | ANDA | View NDC → |
| 500 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 1000 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 500 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 500 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 500 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 1000 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 500 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 1000 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 500 mg | Oral | AvKARE | ANDA | View NDC → |
| 1000 mg | Oral | AvKARE | ANDA | View NDC → |
| 500 mg | Oral | AvPAK | ANDA | View NDC → |
| 1000 mg | Oral | AvPAK | ANDA | View NDC → |
| 500 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 500 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 1000 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 1000 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 500 mg | Oral | i3 Pharmaceuticals, LLC | ANDA | View NDC → |
| 1000 mg | Oral | i3 Pharmaceuticals, LLC | ANDA | View NDC → |
| 500 mg | Oral | Lifestar Pharma LLC | ANDA | View NDC → |
| 1000 mg | Oral | Lifestar Pharma LLC | ANDA | View NDC → |
| 500 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 1000 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 500 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 500 mg | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| 1000 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 500 mg | Oral | Radha Pharmaceuticals, Inc | ANDA | View NDC → |
| 1000 mg | Oral | Radha Pharmaceuticals, Inc | ANDA | View NDC → |
| 500 mg | Oral | ScieGen Pharmaceuticals, Inc | ANDA | View NDC → |
| 1000 mg | Oral | ScieGen Pharmaceuticals, Inc | ANDA | View NDC → |
| 500 mg | Oral | SunGen Pharma LLC | ANDA | View NDC → |
| 1000 mg | Oral | SunGen Pharma LLC | ANDA | View NDC → |
| 500 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 1000 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Torrent Pharma, Inc. | ANDA | View NDC → |
| 1000 mg | Oral | Torrent Pharma, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Umedica Laboratories USA Inc. | ANDA | View NDC → |
| 1000 mg | Oral | Umedica Laboratories USA Inc. | ANDA | View NDC → |
| 500 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 1000 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 500 mg | Oral | Viona Pharmaceuticals Inc | ANDA | View NDC → |
| 1000 mg | Oral | Viona Pharmaceuticals Inc | ANDA | View NDC → |
| 500 mg | Oral | Westminster Pharmaceuticals, LLC | ANDA | View NDC → |
| 1000 mg | Oral | Westminster Pharmaceuticals, LLC | ANDA | View NDC → |
| 500 mg | Oral | Zameer Pharmaceuticals LLC | ANDA | View NDC → |
| 1000 mg | Oral | Zameer Pharmaceuticals LLC | ANDA | View NDC → |
| 500 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 1000 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 💊Oral powder | ||||
| 1000 mg | Oral | Sun Pharmaceutical Industries, Inc. | NDA | View NDC → |
Showing 55 of 55 products — FDA National Drug Code Directory. See every product, package size and price: browse all 55 Ranolazine NDCs →
Ranolazine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ranolazine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ranolazine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Ranolazine FDA approval history
How Ranolazine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
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.
- 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 →
- 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.
RxCUI 35829 2 dose forms · 4 strengths
-
Dose form (SCDF) Extended Release Oral Tablet RxCUI 616491In current FDA listingsClinical drug / strength (SCD) 12 HR ranolazine 1000 MGRxCUI 72823112 HR ranolazine 500 MGRxCUI 616749 -
Dose form (SCDF) Oral Granules RxCUI 2594752In current FDA listings
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.
Ranolazine supply and shortage status
Whether Ranolazine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 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.
| Form | Strength | Pharmacy 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 |
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.
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.
…and 4 more on the FDA NDC directory.
Ranolazine drug class (RxNorm)
Ranolazine belongs to the Anti-anginal class.
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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