Prescription medicine
Ranolazine Brand names: Aspruzyo; first approved as Ranexa
Ranolazine (Ranexa) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 28 generic labelers, and pharmacies paid $0.165 per ranolazine ER 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the ranolazine FDA label on DailyMed (effective January 23, 2026, Glenmark Pharmaceuticals Inc., USA); the NDA 21526 record on Drugs@FDA; every ranolazine label on DailyMed.
Highlights of the record
FDA label of January 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRanolazine extended-release tablets are indicated for the treatment of chronic angina.
Forms and strengths
- 500 mg
- 1000 mg
Film-coated extended-release tablet; extended-release tablet; granule.
On the market
- Earliest approval on file
- January 27, 2006 Ranexa, Menarini Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first July 29, 2013; 19 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 28 of which 28 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 24, 2038 Aspruzyo Sprinkle granule; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.165 per tablet Ranolazine ER 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest March 13, 2025; 1 more by firms not listed as its makers
- FAERS reports
- 10,376 through July 30, 2026
What is ranolazine used for?
From the label: indications and usageRanolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. Ranolazine extended-release tablets are an antianginal indicated for the treatment of chronic angina.
Conditions named in the indications of ranolazine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Anti-anginal.
Source: FDA drug label (Ranolazine), Glenmark Pharmaceuticals Inc., USA, effective January 23, 2026 (SPL set 0cf58732-c242-49b0-8e3f-248778b4458d), via openFDA; the full label on DailyMed
What does the patient leaflet for ranolazine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking ranolazine extended-release tablets?Grapefruit and grapefruit juice. Limit products that have grapefruit in them. They can cause your blood levels of ranolazine extended-release tablets to increase. • Ranolazine extended-release tablets can cause dizziness, lightheadedness, or fainting. If you have these symptoms, do not drive a car, use machinery, or do anything that needs you to be alert.
From the patient leaflet: How should I store ranolazine extended-release tablets?Store ranolazine extended-release tablets at room temperature between 59°F to 86°F (15°C to 30°C). Keep ranolazine extended-release tablets and all medicines out of the reach of children.
Source: FDA drug label (Ranolazine), Glenmark Pharmaceuticals Inc., USA, effective January 23, 2026 (SPL set 0cf58732-c242-49b0-8e3f-248778b4458d), via openFDA; the full label on DailyMed
Is there a generic for ranolazine (Ranexa)?
The FDA approved the first generic ranolazine on July 29, 2013. 27 generic applications are approved; 19 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists ranolazine from 28 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Ranexa tablets; a patent listed only for Aspruzyo Sprinkle granule runs to January 24, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2006 earliest approval on file
- 2013 first generic approved
- 2038 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ranolazine (Ranexa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.165 per Ranolazine ER 500 mg tablet, down 2% from $0.169 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ranolazine ER 500 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ranolazine ER 1,000 mg tablet | Generic | $0.274 per tablet | $8.23 | -1% |
| Ranolazine ER 500 mg tablet | Generic | $0.165 per tablet | $4.95 | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ranolazine been recalled?
The FDA's Enforcement Report lists 3 recalls naming ranolazine since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 2 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of ranolazine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| October 23, 2023 | Class II | Glenmark Pharmaceuticals Inc., USA | Failed Dissolution Specifications: Out of specification for dissolution. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD25452_16, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ranolazine label say about other medicines?
The ranolazine label names 23 other medicines in its interaction, contraindication or warning sections. The labels of 29 other medicines name ranolazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | CYP3A Inducers Do not use ranolazine with CYP3A inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John’s wort [see Contraindications (4), Clinical Pharmacology (12.3) ]. |
| Clarithromycin | contraindications | Strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, nelfinavir) |
| Cyclosporine | drug interactions | P-gp inhibitors (e.g., cyclosporine): Ranolazine exposure increased. |
| Digoxin | drug interactions | 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. |
| Diltiazem | drug interactions | Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin): Limit ranolazine extended-release tablets to 500 mg twice daily. |
| Erythromycin | drug interactions | Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin): Limit ranolazine extended-release tablets to 500 mg twice daily. |
| Fluconazole | drug interactions | 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 … |
| Itraconazole | drug interactions | Drugs on Ranolazine Strong CYP3A Inhibitors Do not use ranolazine with strong CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir [see Contraindications (4), Clinical Pharmacology (12.3) ]. |
| Ketoconazole | contraindications | Strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, nelfinavir) |
| Lovastatin | drug interactions | 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. |
| Metformin | drug interactions | Drugs Transported by OCT2 In subjects with type 2 diabetes mellitus, concomitant use of ranolazine extended-release tablets 1000 mg twice daily and metformin results in increased plasma levels of metformin. |
| Nefazodone | drug interactions | Drugs on Ranolazine Strong CYP3A Inhibitors Do not use ranolazine with strong CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir [see Contraindications (4), Clinical Pharmacology (12.3) ]. |
| Nelfinavir | contraindications | Strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, nelfinavir) |
| Phenobarbital | contraindications | CYP3A inducers (e.g., rifampin, phenobarbital, St. John’s wort) |
Every other medicine the ranolazine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Phenytoin | drug interactions | CYP3A Inducers Do not use ranolazine with CYP3A inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. … |
| Rifabutin | drug interactions | CYP3A Inducers Do not use ranolazine with CYP3A inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. … |
| Rifampin | contraindications | CYP3A inducers (e.g., rifampin, phenobarbital, St. John’s wort) |
| Rifapentine | drug interactions | CYP3A Inducers Do not use ranolazine with CYP3A inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. … |
| Ritonavir | drug interactions | … ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir [see Contraindications (4), Clinical Pharmacology (12.3) ]. |
| Simvastatin | drug interactions | CYP3A substrates: Limit simvastatin to 20 mg when used with ranolazine. |
| Sirolimus | drug interactions | 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. |
| Tacrolimus | drug interactions | 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. |
| Verapamil | drug interactions | Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin): Limit ranolazine extended-release tablets to 500 mg twice daily. |
Other labels that name ranolazine
Source: FDA drug label (Ranolazine), Glenmark Pharmaceuticals Inc., USA, effective January 23, 2026 (SPL set 0cf58732-c242-49b0-8e3f-248778b4458d), via openFDA; the full label on DailyMed
What do FAERS reports show for ranolazine?
The FDA Adverse Event Reporting System holds 10,376 reports that list ranolazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,337 are coded as a death and 4,453 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ranolazine?
4 other medicines are given the same way (oral) and in the same FDA class as ranolazine or labeled mainly for the same use (angina), the same class first. Angina lists all 21 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Isosorbide mononitrate | Angina | 21 labelers | $0.0688 per tablet 30 mg tablet | No current entry |
| Isosorbide dinitrate | Angina | 17 labelers | $0.154 per tablet 10 mg tablet | No current entry |
| Nadolol | Angina | 16 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Nitroglycerin | Angina | 2 labelers | $23.52 per gram 400 mcg spray | A presentation being discontinued |
Every medicine labeled for the same conditions as ranolazine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ranolazine compare with medicines for the same use?
1 side-by-side page set ranolazine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ranolazine
- 4 medicines for the same use
- Ranolazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other