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Ranolazine 1000 mg Tablet, Film Coated, Extended Release, 180-count — NDC 71205-0868-78 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ranolazine 1000 mg Tablet, Film Coated, Extended Release, 180-count — NDC 71205-868-78 (Billing 71205-0868-78)

by Proficient Rx LP · 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

This is a package of 180 tablets of Ranolazine 1000 mg Tablet, Film Coated, Extended Release from Proficient Rx LP, marketed since Aug 2021 and currently FDA-listed.

NDC 71205-0868-78
🏷️ FDA NDC (as labeled) 71205-868-78 billing pads the product segment with a zero
This package
Contains180-count Pack sizes7 compare ↓
Also priced by: Part D plans $0.5718/unit — full pricing hub ↓
Product page 71205-0868-00 Also comes in: 30 tablets 71205-868-30 60 tablets 71205-868-60 90 tablets 71205-868-90 100 tablets 71205-868-00 120 tablets 71205-868-72 500 tablets 71205-868-55
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Ranolazine (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0335-2025
Class II · Oct 23, 2023 — Failed Dissolution Specifications: Out of specification for dissolution. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0092-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71205-868-78
Product NDC 71205-868
11-digit billing NDC 71205086878
NCPDP billing unit EA — each (per item)
RxCUI 616749, 728231
UNII A6IEZ5M406
UPC 0371205868789, 0371205867782
Application # ANDA211829
SPL Set ID 989e1688-a0b5-4297-bf91-234de2a0b445
Established class (EPC) Anti-anginal
Mechanism of action Cytochrome P450 3A Inhibitors; P-Glycoprotein Inhibitors; Cytochrome P450 2D6 Inhibitors; Organic Cation Transporter 2 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-08-24
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance RANOLAZINE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 32200040007430
GPI class Ranolazine ER
GCN Seq No 062973
GCN 98733
HICL code 033446
Ingredient (HICL) Ranolazine
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A2
Therapeutic class — intermediate (HIC2) Cardiac Depressants
HIC3 code A2C
Therapeutic class — specific (HIC3) Antianginal, Anti-Ischemic Agents,Non-Hemodynamic
AHFS code 24:04.92.00
AHFS class Cardiac Drugs, Miscellaneous
FDB label name RANOLAZINE ER 1,000 MG TABLET
FDB brand name Ranolazine Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 062973
  • GCN: 98733
  • GPI-14 (Medi-Span): 32200040007430
  • HICL (First Databank): 033446
  • AHFS class code: 24:04.92.00
  • RxCUI (RxNorm): 616749
Why two NDCs? The FDA registers this code as 71205-868-78 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71205-0868-78. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine 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
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name RANOLAZINE ER 1,000 MG TABLET Ingredient Ranolazine
📗 Our plain-language guide HelloPharmacist
  • 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...
  • 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...
  • 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,...
  • 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 diltia...
📖 Read our full Ranolazine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.5718 $102.92 / 180 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71205-0868-00 71205-868-00 Main listing 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 2021-12-17 — Active
71205-0868-30 71205-868-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 2021-12-17 — Active
71205-0868-55 71205-868-55 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 2021-12-17 — Active
71205-0868-60 71205-868-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 2021-12-17 — Active
71205-0868-72 71205-868-72 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 2021-12-17 — Active
71205-0868-78 You're viewing this 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 2021-12-17 — Active
71205-0868-90 71205-868-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 2021-12-17 — Active

You're viewing one of 7 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 180-count package — 180 tablet, film coated, extended release in 1 bottle.
How does this package differ from NDC 71205-0868-30?
Both are Ranolazine 1000 mg Tablet, Film Coated, Extended Release — the drug itself is identical. This page's package is the 180-count one, while NDC 71205-0868-30 is the 30 tablets package.
What NDC number is used to bill for this package of Ranolazine 1000 mg Tablet, Film Coated, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ranolazine 1000 mg 27241-0126-02 Ajanta 60 tablets $0.274 AB Availability likely —
Ranolazine 1000 mg 31722-0669-60 Camber 60 tablets $0.274 AB Availability likely —
Ranolazine 1000 mg 50268-0723-13 AvPAK 1 tablet $0.274 AB Availability likely —
Ranolazine 1000 mg 69367-0294-60 Westminster 60 tablets $0.274 AB Availability likely —
Ranolazine 1000 mg 70756-0704-60 Lifestar 60 tablets $0.274 AB Availability likely —
Ranolazine 1000 mg 72319-0022-02 i3 60 tablets $0.274 AB Availability likely —
Ranolazine 1000 mg 90096-0152-60 Zameer 60 tablets $0.274 AB Availability likely —
Ranolazine 1000 mg 13668-0760-60 Torrent 60 tablets — AB FDA listed —
Ranolazine 1000 mg 29300-0297-01 Unichem 100 tablets — AB FDA listed —
Ranolazine 1000 mg 42291-0774-60 AvKARE 60 tablets — AB FDA listed —
Ranolazine 1000 mg 42571-0325-11 Micro 10 tablets — AB Discontinued —
Ranolazine 1000 mg 50228-0424-05 ScieGen 500 tablets — AB FDA listed —
Ranolazine 1000 mg 59651-0010-18 Aurobindo 180 tablets — — FDA listed —
Ranolazine 1000 mg 63304-0018-05 Sun 500 tablets — — FDA listed —
Ranolazine 1000 mg 67877-0526-05 Ascend 500 tablets — AB FDA listed —
Ranolazine 1000 mg 68462-0320-05 Glenmark 500 tablets — AB FDA listed —
Ranolazine 1000 mg 70625-0207-01 SunGen 60 tablets — AB FDA listed —
Ranolazine 1000 mg 70771-1500-01 Zydus 100 tablets — AB FDA listed —
Ranolazine 1000 mgthis 71205-0868-78 Proficient 180 tablets — AB FDA listed —
Ranolazine 1000 mg 72578-0065-01 Viona 100 tablets — AB FDA listed —
Ranolazine 1000 mg 73141-0022-02 A2A 60 tablets — AB FDA listed —
Ranolazine 1000 mg 77771-0424-60 Radha 60 tablets — AB FDA listed —
Ranolazine 1000 mg 68180-0355-02 Lupin 500 tablets — AB FDA listed —
Ranolazine 1000 mg 60290-0056-01 Umedica 60 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Aug 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Orange / Yellow
ShapeOval
ImprintSG;424
Size22 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA211829 (ANDA)
Labeler code71205
First marketedAug 2021
Product typeHuman Prescription Drug
Portfolio1,729 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 53 words ▾

1 INDICATIONS AND USAGE Ranolazine 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. ( 1 )

⏱️ Dosage and Administration 201 words ▾

2 DOSAGE AND ADMINISTRATION 500 mg twice daily and increase to 1000 mg twice daily, based on clinical symptoms ( 2.1 )

2.1Dosing 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.

2.2Dose Modification Dose adjustments may be needed when Ranolazine extended-release tablets are 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) ].

💊 Dosage Forms and Strengths 63 words ▾

3 DOSAGE FORMS AND STRENGTHS Ranolazine extended-release tablets are in the following strengths: 1. Peach, oblong shaped, film-coated, extended release tablet debossed with "423" on one side and "SG" on the other side. 2. Pale yellow, oblong shaped, film-coated, extended release tablet debossed with "424" on one side and "SG" on the other side. Extended-release tablets: 500 mg, 1000 mg ( 3 )

⛔ Contraindications 75 words ▾

4 CONTRAINDICATIONS Ranolazine extended-release tablets are contraindicated in patients: 1. Taking strong inhibitors of CYP3A [see Drug Interactions (7.1) ] 2. Taking inducers of CYP3A [see Drug Interactions (7.1) ] 3.

With liver cirrhosis [see Use in Specific Populations (8.6) ] 4. Strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, nelfinavir) ( 4 , 7.1 ) 5. CYP3A inducers (e.g., rifampin, phenobarbital, St.John's wort) ( 4 , 7.1 ) 6.

Liver cirrhosis ( 4 , 8.6 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS 3. QT interval prolongation: Can occur with ranolazine. Little data available on high doses, long exposure, use with QT interval- prolonging drugs, potassium channel variants causing prolonged QT interval, in patients with a family history of (or congenital) long QT syndrome, or in patients with known acquired QT interval prolongation ( 5.1 ) 4.

Renal failure: Monitor renal function after initiation and periodically in patients with moderate to severe renal impairment (CrCL<60 mL/min). If acute renal failure develops, discontinue Ranolazine extended-release tablets. ( 5.2 )

5.1QT Interval Prolongation Ranolazine blocks I Kr and prolongs the QTc interval in a dose-related manner. Clinical experience in an acute coronary syndrome population did not show an increased risk of proarrhythmia or sudden death [see Clinical Studies (14.2) ]. However, there is little experience with high doses (>1000 mg twice daily) or exposure, other QT-prolonging drugs, potassium channel variants resulting in a long QT interval, in patients with a family history of (or congenital) long QT syndrome, or in patients with known acquired QT interval prolongation.

5.2Renal Failure Acute renal failure has been observed in some patients with severe renal impairment (creatinine clearance [CrCL] <30 mL/min) while taking Ranolazine extended-release tablets. If acute renal failure develops (e.g., marked increase in serum creatinine associated with an increase in blood urea nitrogen [BUN]), discontinue Ranolazine extended-release tablets and treat appropriately [see Use in Specific Populations (8.7) ]. Monitor renal function after initiation and periodically in patients with moderate to severe renal impairment (CrCL <60 mL/min) for increases in serum creatinine accompanied by an increase in BUN.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (>4% and more common than with placebo) are dizziness, headache, constipation, nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 2018 patients with chronic angina were treated with ranolazine in controlled clinical trials. Of the patients treated with Ranolazine extended-release tablets, 1026 were enrolled in three double-blind, placebo-controlled, randomized studies (CARISA, ERICA, MARISA) of up to 12 weeks' duration.

In addition, upon study completion, 1251 patients received treatment with Ranolazine extended-release tablets in open-label, long-term studies; 1227 patients were exposed to Ranolazine extended-release tablets for more than 1 year, 613 patients for more than 2 years, 531 patients for more than 3 years, and 326 patients for more than 4 years. At recommended doses, about 6% of patients discontinued treatment with Ranolazine extended-release tablets because of an adverse event in controlled studies in angina patients compared to about 3% on placebo.

The most common adverse events that led to discontinuation more frequently on Ranolazine extended-release tablets than placebo were dizziness (1.3% versus 0.1%), nausea (1% versus 0%), asthenia, constipation, and headache (each about 0.5% versus 0%). Doses above 1000 mg twice daily are poorly tolerated. In controlled clinical trials of angina patients, the most frequently reported treatment-emergent adverse reactions (>4% and more common on Ranolazine extended-release tablets than on placebo) were dizziness (6.2%), headache (5.5%), constipation (4.5%), and nausea (4.4%).

Dizziness may be dose-related. In open-label, long-term treatment studies, a similar adverse reaction profile was observed. The following additional adverse reactions occurred at an incidence of 0.5 to 4.0% in patients treated with Ranolazine extended-release tablets and were more frequent than the incidence observed in placebo-treated patients: Cardiac Disorders – bradycardia, palpitations Ear and Labyrinth Disorders – tinnitus, vertigo Eye Disorders – blurred vision Gastrointestinal Disorders – abdominal pain, dry mouth, vomiting, dyspepsia General Disorders and Administrative Site Adverse Events – asthenia, peripheral edema Metabolism and Nutrition Disorders – anorexia Nervous System Disorders – syncope (vasovagal) Psychiatric Disorders – confusional state Renal and Urinary Disorders – hematuria Respiratory, Thoracic, and Mediastinal Disorders – dyspnea Skin and Subcutaneous Tissue Disorders – hyperhidrosis Vascular Disorders – hypotension, orthostatic hypotension Other (<0.5%) but potentially medically important adverse reactions observed more frequently with Ranolazine extended-release tablets than placebo treatment in all controlled studies included: angioedema, renal failure, eosinophilia, chromaturia, blood urea increased, hypoesthesia, paresthesia, tremor, pulmonary fibrosis, thrombocytopenia, leukopenia, and pancytopenia.

A large clinical trial in acute coronary syndrome patients was unsuccessful in demonstrating a benefit for Ranolazine extended-release tablets, but there was no apparent proarrhythmic effect in these high-risk patients [see Clinical Studies (14.2) ]. Laboratory Abnormalities: Ranolazine extended-release tablets produces elevations of serum creatinine by 0.1 mg/dL, regardless of previous renal function, likely because of inhibition of creatinine's tubular secretion. In general, the elevation has a rapid onset, shows no signs of progression during long-term therapy, is reversible after discontinuation of Ranolazine ex… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS 6. Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin): Limit Ranolazine extended-release tablets to 500 mg twice daily. ( 7.1 ) 7.

P-gp inhibitors (e.g., cyclosporine): Ranolazine exposure increased. Titrate Ranolazine extended-release tablets based on clinical response. ( 7.1 ) 8.

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 ) 9.

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 ) 10.

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 )

7.1Effects 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. Titrate Ranolazine extended-release tablets based on clinical response in patients concomitantly treated with predominant P-gp inhibitors such as cyclosporine [see Dosage and Administration (2.2) ]. CYP3A Inducers Do not use Ranolazine extended-release tablets with CYP3A inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St.

John's wort [see Contraindications (4) , Clinical Pharmacology (12.3) ].

7.2Effects of Ranolazine on Other Drugs Drugs Metabolized by CYP3A Limit the dose of simvastatin in patients on any dose of Ranolazine extended-release tablets to 20 mg once daily, when ranolazine is co-administered. Dose adjustment of other sensitive CYP3A substrates (e.g., lovastatin) and CYP3A substrates with a narrow therapeutic range (e.g., cyclosporine, tacrolimus, sirolimus) may be required as Ranolazine extended-release tablets may increase plasma concentrations of these drugs [see Clinical Pharmacology (12.3) ].

Drugs Transported by P-gp Concomitant use of ranolazine and digoxin results in increased exposure to digoxin. The dose of digoxin may have to be adjusted [see Clinical Pharmacology (12.3) ] Drugs Metabolized by CYP2D6 The exposure to CYP2D6 substrates, such as tricyclic antidepressants and antipsychotics, may be increased during co-administration with Ranolazine extended-release tablets, and lower doses of these drugs may be required. 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.

When Ranolazine extended-release tablets 1000 mg twice daily is co-administered with metformin, metformin dose should not exceed 1700 mg/day. Monitor blood glucose levels and risks associated with high exposures of metformin. Metformin exposure was not significantly increased when given with Ranolazine extended-release tablets 500 mg twice daily [see Clinical Pharmacology (12.3) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on Ranolazine extended-release tablets use in pregnant women to inform any drug-associated risks. Studies in rats and rabbits showed no evidence of fetal harm at exposures 4 times the maximum recommended human dose (MRHD) (see Data ). In the U.S. general population, the estimated background risk of major birth defects and of miscarriage of clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data Embryofetal toxicity studies were conducted in rats and rabbits orally administered ranolazine during organogenesis. In rats, decreased fetal weight and reduced ossification were observed at doses (corresponding to 4-fold the AUC for the MRHD) that caused maternal weight loss. No adverse fetal effects were observed in either species exposed (AUC) to ranolazine at exposures (AUC) equal to the MRHD.

8.2Lactation Risk Summary There are no data on the presence of ranolazine in human milk, the effects on the breastfed infant, or the effects on milk production. However, ranolazine is present in rat milk [see Use in Specific Populations (8.1) ]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Ranolazine extended-release tablets and any potential adverse effects on the breastfed infant from Ranolazine extended-release tablets or from the underlying maternal condition.

Adult female rats were administered ranolazine orally from gestation day 6 through postnatal day 20. No adverse effects on pup development, behavior, or reproduction parameters were observed at a maternal dosage level of 60 mg/kg/day (equal to the MHRD based on AUC). At maternally toxic doses, male and female pups exhibited increased mortality and decreased body weight, and female pups showed increased motor activity.

The pups were potentially exposed to low amounts of ranolazine via the maternal milk.

8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients.

8.5Geriatric Use Of the chronic angina patients treated with Ranolazine extended-release tablets in controlled studies, 496 (48%) were ≥65 years of age, and 114 (11%) were ≥75 years of age. No overall differences in efficacy were observed between older and younger patients. There were no differences in safety for patients ≥65 years compared to younger patients, but patients ≥75 years of age on Ranolazine extended-release tablets, compared to placebo, had a higher incidence of adverse events, serious adverse events, and drug discontinuations due to adverse events.

In general, dose selection for an elderly patient should usually start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease, or other drug therapy.

8.6Use in Patients with Hepatic Impairment Ranolazine extended-release tablets are contraindicated in patients with liver cirrhosis. In a study of cirrhotic patients, the C max of ranolazine was increased 30% in cirrhotic patients with mild (Child-Pugh Class A) hepatic impairment, but increased 80% in cirrhotic patients with moderate (Child-Pugh Class B) hepatic impairment compared to patients without hepatic impairment. This increase was not enough to account for the 3-fold increase in QT prolongation seen in cirrhotic patients with mild to moderate hepatic impairment [see Clinical Pharmacology (12.2) ].

8.7Use in Patients with Renal Impairment A pharmacokinetic study of Ranolazine extended-release tablets in subjects with severe renal impairment (CrCL <30 mL/min) was stopped when 2 of 4 subjects developed acute renal failure after receiving Ranolazine extended-release tablets 500 mg twice daily for 5 days (lead-in phase) followed by 1000 mg twice a day (1 dose in one subject and 11 doses in the other). Increases in creatinine, BUN, and potassium were observed in 3 subjects during the 500 mg lead-in phase.… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 137 words ▾

8.1Pregnancy Risk Summary There are no available data on Ranolazine extended-release tablets use in pregnant women to inform any drug-associated risks. Studies in rats and rabbits showed no evidence of fetal harm at exposures 4 times the maximum recommended human dose (MRHD) (see Data ). In the U.S. general population, the estimated background risk of major birth defects and of miscarriage of clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data Embryofetal toxicity studies were conducted in rats and rabbits orally administered ranolazine during organogenesis. In rats, decreased fetal weight and reduced ossification were observed at doses (corresponding to 4-fold the AUC for the MRHD) that caused maternal weight loss. No adverse fetal effects were observed in either species exposed (AUC) to ranolazine at exposures (AUC) equal to the MRHD.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients.

🧓 Geriatric Use 125 words ▾

8.5Geriatric Use Of the chronic angina patients treated with Ranolazine extended-release tablets in controlled studies, 496 (48%) were ≥65 years of age, and 114 (11%) were ≥75 years of age. No overall differences in efficacy were observed between older and younger patients. There were no differences in safety for patients ≥65 years compared to younger patients, but patients ≥75 years of age on Ranolazine extended-release tablets, compared to placebo, had a higher incidence of adverse events, serious adverse events, and drug discontinuations due to adverse events.

In general, dose selection for an elderly patient should usually start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease, or other drug therapy.

🆘 Overdosage 92 words ▾

10 OVERDOSAGE Hypotension, QT prolongation, bradycardia, myoclonic activity, severe tremor, unsteady gait/incoordination, dizziness, nausea, vomiting, dysphasia, and hallucinations have been seen in cases of oral overdose of Ranolazine extended-release tablets. In cases of extreme overdose of Ranolazine extended-release tablets fatal outcomes have been reported. In clinical studies, high intravenous exposure resulted in diplopia, paresthesia, confusion, and syncope.

In addition to general supportive measures, continuous ECG monitoring may be warranted in the event of overdose. Since Ranolazine is about 62% bound to plasma proteins, hemodialysis is unlikely to be effective in clearing Ranolazine.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of ranolazine's antianginal effects has not been determined. Ranolazine has anti-ischemic and antianginal effects that do not depend upon reductions in heart rate or blood pressure. It does not affect the rate-pressure product, a measure of myocardial work, at maximal exercise.

Ranolazine at therapeutic levels can inhibit the cardiac late sodium current (I Na ). However, the relationship of this inhibition to angina symptoms is uncertain. The QT prolongation effect of ranolazine on the surface electrocardiogram is the result of inhibition of I Kr , which prolongs the ventricular action potential.

12.2Pharmacodynamics Hemodynamic Effects Patients with chronic angina treated with Ranolazine extended-release tablets in controlled clinical studies had minimal changes in mean heart rate (<2 bpm) and systolic blood pressure (<3 mm Hg). Similar results were observed in subgroups of patients with CHF NYHA Class I or II, diabetes, or reactive airway disease, and in elderly patients. Electrocardiographic Effects Dose and plasma concentration-related increases in the QTc interval [see Warnings and Precautions (5.1) ], reductions in T wave amplitude, and, in some cases, notched T waves, have been observed in patients treated with Ranolazine extended-release tablets.

These effects are believed to be caused by ranolazine and not by its metabolites. The relationship between the change in QTc and ranolazine plasma concentrations is linear, with a slope of about 2.6 msec/1000 ng/mL, through exposures corresponding to doses several-fold higher than the maximum recommended dose of 1000 mg twice daily. The variable blood levels attained after a given dose of ranolazine give a wide range of effects on QTc.

At T max following repeat dosing at 1000 mg twice daily, the mean change in QTc is about 6 msec, but in the 5% of the population with the highest plasma concentrations, the prolongation of QTc is at least 15 msec. In cirrhotic subjects with mild or moderate hepatic impairment, the relationship between plasma level of ranolazine and QTc is much steeper [see Contraindications (4) ]. Age, weight, gender, race, heart rate, congestive heart failure, diabetes, and renal impairment did not alter the slope of the QTc-concentration relationship of ranolazine.

No proarrhythmic effects were observed on 7-day Holter recordings in 3162 acute coronary syndrome patients treated with Ranolazine extended-release tablets. There was a significantly lower incidence of arrhythmias (ventricular tachycardia, bradycardia, supraventricular tachycardia, and new atrial fibrillation) in patients treated with Ranolazine extended-release tablets (80%) versus placebo (87%), including ventricular tachycardia ≥3 beats (52% versus 61%). However, this difference in arrhythmias did not lead to a reduction in mortality, a reduction in arrhythmia hospitalization, or a reduction in arrhythmia symptoms.

12.3Pharmacokinetics Ranolazine is extensively metabolized in the gut and liver and its absorption is highly variable. For example, at a dose of 1000 mg twice daily, the mean steady-state C max was 2600 ng/mL with 95% confidence limits of 400 and 6100 ng/mL. The pharmacokinetics of the (+) R-and (-) S-enantiomers of ranolazine are similar in healthy volunteers.

The apparent terminal half-life of ranolazine is 7 hours. Steady state is generally achieved within 3 days of twice-daily dosing with Ranolazine extended-release tablets. At steady state over the dose range of 500 to 1000 mg twice daily, C max and AUC 0-T increase slightly more than proportionally to dose, 2.2-and 2.4-fold, respectively.

With twice-daily dosing, the trough:peak ratio of the ranolazine plasma concentration is 0.3 to 0.6. The pharmacokinetics of ranolazine is unaffected by age, gender, or food. Absorption and Distribution After oral administration of Ranolazine extended-release tablets, peak plasma concentrations of ranolazine are reached… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 99 words ▾

12.1Mechanism of Action The mechanism of action of ranolazine's antianginal effects has not been determined. Ranolazine has anti-ischemic and antianginal effects that do not depend upon reductions in heart rate or blood pressure. It does not affect the rate-pressure product, a measure of myocardial work, at maximal exercise.

Ranolazine at therapeutic levels can inhibit the cardiac late sodium current (I Na ). However, the relationship of this inhibition to angina symptoms is uncertain. The QT prolongation effect of ranolazine on the surface electrocardiogram is the result of inhibition of I Kr , which prolongs the ventricular action potential.

📦 How Supplied / Storage and Handling 173 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ranolazine extended-release tablets are supplied as film-coated, oblong-shaped, extended-release tablets in the following strengths: 1. 500 mg tablets are peach, with "423" on one side and "SG" on the other side 2. 1000 mg tablets are pale yellow, with "424" on one side and "SG" on the other side Ranolazine extended-release tablets 500 mg are available in: Bottle of 30 Tablets: NDC 71205-867-30 Bottle of 60 Tablets: NDC 71205-867-60 Bottle of 90 Tablets: NDC 71205-867-90 Bottle of 100 Tablets: NDC 71205-867-00 Bottle of 120 Tablets: NDC 71205-867-72 Bottle of 180 Tablets: NDC 71205-867-78 Bottle of 500 Tablets: NDC 71205-867-55 Ranolazine extended-release tablets 1000 mg are available in: Bottle of 30 Tablets: NDC 71205-868-30 Bottle of 60 Tablets: NDC 71205-868-60 Bottle of 90 Tablets: NDC 71205-868-90 Bottle of 100 Tablets: NDC 71205-868-00 Bottle of 120 Tablets: NDC 71205-868-72 Bottle of 180 Tablets: NDC 71205-868-78 Bottle of 500 Tablets: NDC 71205-868-55 Store at 25°C (77°F); with excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]

📦 Storage and Handling 19 words ▾

Store at 25°C (77°F); with excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]

📋 Description 153 words ▾

11 DESCRIPTION Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N- (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C 24 H 33 N 3 O 4 , a molecular weight of 427.54 g/mole, and the following structural formula: Ranolazine is a white to off-white crystalline powder.

Ranolazine is soluble in dichloromethane and methanol. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, hypromellose, sodium hydroxide and magnesium stearate. Additional inactive ingredients for the 500 mg tablet include hydroxypropyl methyl cellulose, titanium dioxide, lactose monohydrate, polyethylene glycol, triacetin, Iron Oxide Yellow, and Iron Oxide Red; additional inactive ingredients for the 1000 mg tablet include hydroxypropyl methyl cellulose, titanium dioxide, lactose monohydrate, polyethylene glycol, triacetin and Iron Oxide Yellow.

Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients that Ranolazine extended-release tablets will not abate an acute angina episode. Strong CY3PA Inhibitors, CYP3A Inducers, Liver Cirrhosis 1.

Inform patients that Ranolazine extended-release tablets should not be used with drugs that are strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir) [(see Contraindications (4) , Drug Interactions (7.1) ]. 2. Inform patients that Ranolazine extended-release tablets should not be used with drugs that are inducers of CYP3A (e.g., rifampin, rifabutin, rifapentine, barbiturates, carbamazepine, phenytoin, St.

John's wort) [(see Contraindications (4) , Drug Interactions (7.1) ]. 3. Inform patients that Ranolazine extended-release tablets should not be used in patients with liver cirrhosis [(see Contraindications (4) , Use in Specific Populations (8.6) ].

Moderate CYP3A Inhibitors, P-gp Inhibitors, Grapefruit Products 1. Advise patients to inform their physician if they are receiving drugs that are moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin) [see Drug Interactions (7) ]. 2.

Advise patients to inform their physician if they are receiving drugs that are P-gp inhibitors (e.g., cyclosporine) [see Drug Interactions (7) ]. 3. Advise patients to limit grapefruit juice or grapefruit products when taking Ranolazine extended-release tablets [see Drug Interactions (7) ].

QT Interval Prolongation 1. Inform patients that Ranolazine extended-release tablets may produce changes in the electrocardiogram (QTc interval prolongation) [see Warnings and Precautions (5.1) ]. 2.

Advise patients to inform their physician of any personal or family history of QTc prolongation, congenital long QT syndrome, or if they are receiving drugs that prolong the QTc interval such as Class Ia (e.g., quinidine) or Class III (e.g., dofetilide, sotalol, amiodarone) antiarrhythmic agents, erythromycin, and certain antipsychotics (e.g., thioridazine, ziprasidone) [see Warnings and Precautions (5.1) ]. Use in Patients with Renal Impairment Patients with severe renal impairment may be at risk of renal failure while on Ranolazine extended-release tablets.

Advise patients to inform their physician if they have impaired renal function before or while taking Ranolazine extended-release tablets [see Warnings and Precautions (5.2) ]. Dizziness, Fainting 1. Inform patients that Ranolazine extended-release tablets may cause dizziness and lightheadedness.

Patients should know how they react to Ranolazine extended-release tablets before they operate an automobile or machinery, or engage in activities requiring mental alertness or coordination [see Adverse Reactions (6.1) ]. 2. Advise patients to contact their physician if they experience fainting spells while taking Ranolazine extended-release tablets.

Administration 1. Instruct patients to swallow Ranolazine extended-release tablets whole, with or without meals, and not to crush, break, or chew tablets. Inform patients that if a dose is missed, to take the usual dose at the next scheduled time.

The next dose should not be doubled. Inform patients that doses of Ranolazine extended-release tablets higher than 1000 mg twice daily should not be used [see Dosage and Administration (2) ]. 2.

Advise patients to inform their physician of any other medications taken concurrently with Ranolazine extended-release tablets, including over-the-counter medications

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Ranolazine is extensively metabolized in the gut and liver and its absorption is highly variable. For example, at a dose of 1000 mg twice daily, the mean steady-state C max was 2600 ng/mL with 95% confidence limits of 400 and 6100 ng/mL. The pharmacokinetics of the (+) R-and (-) S-enantiomers of ranolazine are similar in healthy volunteers.

The apparent terminal half-life of ranolazine is 7 hours. Steady state is generally achieved within 3 days of twice-daily dosing with Ranolazine extended-release tablets. At steady state over the dose range of 500 to 1000 mg twice daily, C max and AUC 0-T increase slightly more than proportionally to dose, 2.2-and 2.4-fold, respectively.

With twice-daily dosing, the trough:peak ratio of the ranolazine plasma concentration is 0.3 to 0.6. The pharmacokinetics of ranolazine is unaffected by age, gender, or food. Absorption and Distribution After oral administration of Ranolazine extended-release tablets, peak plasma concentrations of ranolazine are reached between 2 and 5 hours.

After oral administration of 14 C-ranolazine as a solution, 73% of the dose is systemically available as ranolazine or metabolites. The bioavailability of ranolazine from Ranolazine extended-release tablets relative to that from a solution of ranolazine is 76%. Because ranolazine is a substrate of P-gp, inhibitors of P-gp may increase the absorption of ranolazine.

Food (high-fat breakfast) has no important effect on the C max and AUC of ranolazine. Therefore, Ranolazine extended-release tablets may be taken without regard to meals. Over the concentration range of 0.25 to 10 mcg/mL, ranolazine is approximately 62% bound to human plasma proteins.

Metabolism and Excretion Ranolazine is metabolized mainly by CYP3A and, to a lesser extent, by CYP2D6. Following a single oral dose of ranolazine solution, approximately 75% of the dose is excreted in urine and 25% in feces. Ranolazine is metabolized rapidly and extensively in the liver and intestine; less than 5% is excreted unchanged in urine and feces.

The pharmacologic activity of the metabolites has not been well characterized. After dosing to steady state with 500 mg to 1500 mg twice daily, the four most abundant metabolites in plasma have AUC values ranging from about 5 to 33% that of ranolazine, and display apparent half-lives ranging from 6 to 22 hours. Drug Interactions Effect of Other Drugs on Ranolazine In vitro data indicate that ranolazine is a substrate of CYP3A and, to a lesser degree, of CYP2D6.

Ranolazine is also a substrate of P-glycoprotein. Strong CYP3A Inhibitors Plasma levels of ranolazine with Ranolazine extended-release tablets 1000 mg twice daily are increased by 220% when co-administered with ketoconazole 200 mg twice daily [see Contraindications (4) ]. Moderate CYP3A Inhibitors Plasma levels of ranolazine with Ranolazine extended-release tablets 1000 mg twice daily are increased by 50 to 130% by diltiazem 180 to 360 mg, respectively.

Plasma levels of ranolazine with Ranolazine extended-release tablets 750 mg twice daily are increased by 100% by verapamil 120 mg three times daily [see Drug Interactions (7.1) ]. Weak CYP3A Inhibitors The weak CYP3A inhibitors simvastatin (20 mg once daily) and cimetidine (400 mg three times daily) do not increase the exposure to ranolazine in healthy volunteers. CYP3A Inducers Rifampin 600 mg once daily decreases the plasma concentrations of ranolazine (1000 mg twice daily) by approximately 95% [see Contraindications (4) ].

CYP2D6 Inhibitors Paroxetine 20 mg once daily increased ranolazine concentrations by 20% in healthy volunteers receiving Ranolazine extended-release tablets 1000 mg twice daily. No dose adjustment of Ranolazine extended-release tablets is required in patients treated with CYP2D6 inhibitors. Digoxin Plasma concentrations of ranolazine are not significantly altered by concomitant digoxin at 0.125 mg once daily.

Effect of Ranolazine on Other Drugs In vitro ranolazine and its O-deme… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Hemodynamic Effects Patients with chronic angina treated with Ranolazine extended-release tablets in controlled clinical studies had minimal changes in mean heart rate (<2 bpm) and systolic blood pressure (<3 mm Hg). Similar results were observed in subgroups of patients with CHF NYHA Class I or II, diabetes, or reactive airway disease, and in elderly patients. Electrocardiographic Effects Dose and plasma concentration-related increases in the QTc interval [see Warnings and Precautions (5.1) ], reductions in T wave amplitude, and, in some cases, notched T waves, have been observed in patients treated with Ranolazine extended-release tablets.

These effects are believed to be caused by ranolazine and not by its metabolites. The relationship between the change in QTc and ranolazine plasma concentrations is linear, with a slope of about 2.6 msec/1000 ng/mL, through exposures corresponding to doses several-fold higher than the maximum recommended dose of 1000 mg twice daily. The variable blood levels attained after a given dose of ranolazine give a wide range of effects on QTc.

At T max following repeat dosing at 1000 mg twice daily, the mean change in QTc is about 6 msec, but in the 5% of the population with the highest plasma concentrations, the prolongation of QTc is at least 15 msec. In cirrhotic subjects with mild or moderate hepatic impairment, the relationship between plasma level of ranolazine and QTc is much steeper [see Contraindications (4) ]. Age, weight, gender, race, heart rate, congestive heart failure, diabetes, and renal impairment did not alter the slope of the QTc-concentration relationship of ranolazine.

No proarrhythmic effects were observed on 7-day Holter recordings in 3162 acute coronary syndrome patients treated with Ranolazine extended-release tablets. There was a significantly lower incidence of arrhythmias (ventricular tachycardia, bradycardia, supraventricular tachycardia, and new atrial fibrillation) in patients treated with Ranolazine extended-release tablets (80%) versus placebo (87%), including ventricular tachycardia ≥3 beats (52% versus 61%). However, this difference in arrhythmias did not lead to a reduction in mortality, a reduction in arrhythmia hospitalization, or a reduction in arrhythmia symptoms.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Chronic Stable Angina CARISA (Combination Assessment of Ranolazine In Stable Angina) was a study in 823 chronic angina patients randomized to receive 12 weeks of treatment with twice-daily Ranolazine extended-release tablets 750 mg, 1000 mg, or placebo, who also continued on daily doses of atenolol 50 mg, amlodipine 5 mg, or diltiazem CD 180 mg. Sublingual nitrates were used in this study as needed. In this trial, statistically significant (p <0.05) increases in modified Bruce treadmill exercise duration and time to angina were observed for each Ranolazine extended-release tablets dose versus placebo, at both trough (12 hours after dosing) and peak (4 hours after dosing) plasma levels, with minimal effects on blood pressure and heart rate.

The changes versus placebo in exercise parameters are presented in Table 1. Exercise treadmill results showed no increase in effect on exercise at the 1000 mg dose compared to the 750 mg dose. Table 1 Exercise Treadmill Results (CARISA) Mean Difference from Placebo (sec) Study CARISA (N=791) Ranolazine extended-release tablets Twice-daily Dose 750 mg 1000 mg Exercise Duration Trough 24 p-value ≤ 0.05 24 Peak 34 p-value ≤ 0.005 26 Time to Angina Trough 30 26 Peak 38 38 Time to 1 mm ST-Segment Depression Trough 20 21 Peak 41 35 The effects of Ranolazine extended-release tablets on angina frequency and nitroglycerin use are shown in Table 2.

Table 2 Angina Frequency and Nitroglycerin Use (CARISA) Placebo Ranolazine extended-release tablets 750 mg Twice daily Ranolazine extended-release tablets 1000 mg Angina Frequency (attacks/week) N 258 272 261 Mean 3.3 2.5

2.1P-value vs Placebo — 0.006 < 0.001 Nitroglycerin Use (doses/week) N 252 262 244 Mean 3.1 2.1

1.8P-value vs placebo — 0.016 < 0.001 Tolerance to Ranolazine extended-release tablets did not develop after 12 weeks of therapy. Rebound increases in angina, as measured by exercise duration, have not been observed following abrupt discontinuation of Ranolazine extended-release tablets. Ranolazine extended-release tablets has been evaluated in patients with chronic angina who remained symptomatic despite treatment with the maximum dose of an antianginal agent.

In the ERICA (Efficacy of Ranolazine In Chronic Angina) trial, 565 patients were randomized to receive an initial dose of Ranolazine extended-release tablets 500 mg twice daily or placebo for 1 week, followed by 6 weeks of treatment with Ranolazine extended-release tablets 1000 mg twice daily or placebo, in addition to concomitant treatment with amlodipine 10 mg once daily. In addition, 45% of the study population also received long-acting nitrates. Sublingual nitrates were used as needed to treat angina episodes.

Results are shown in Table 3. Statistically significant decreases in angina attack frequency (p=0.028) and nitroglycerin use (p=0.014) were observed with Ranolazine extended-release tablets compared to placebo. These treatment effects appeared consistent across age and use of long-acting nitrates.

Table 3 Angina Frequency and Nitroglycerin Use (ERICA) Placebo Ranolazine extended-release tablets 1000 mg twice daily Angina Frequency (attacks/week) N 281 277 Mean 4.3

3.3Median 2.4

2.2Nitroglycerin Use (doses/week) N 281 277 Mean 3.6

2.7Median 1.7

1.3Gender Effects on angina frequency and exercise tolerance were considerably smaller in women than in men. In CARISA, the improvement in Exercise Tolerance Test (ETT) in females was about 33% of that in males at the 1000 mg twice-daily dose level. In ERICA, where the primary endpoint was angina attack frequency, the mean reduction in weekly angina attacks was 0.3 for females and 1.3 for males.

Race There were insufficient numbers of non-Caucasian patients to allow for analyses of efficacy or safety by racial subgroup.

14.2Lack of Benefit in Acute Coronary Syndrome In a large (n=6560) placebo-controlled trial (MERLIN-TIMI 36) in patients with acute coronary syndrome, there was no benefit shown on outcome me… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 187 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Ranolazine tested negative for genotoxic potential in the following assays: Ames bacterial mutation assay, Saccharomyces assay for mitotic gene conversion, chromosomal aberrations assay in Chinese hamster ovary (CHO) cells, mammalian CHO/HGPRT gene mutation assay, and mouse and rat bone marrow micronucleus assays. There was no evidence of carcinogenic potential in mice or rats. The highest oral doses used in the carcinogenicity studies were 150 mg/kg/day for 21 months in rats (900 mg/m 2 /day) and 50 mg/kg/day for 24 months in mice (150 mg/m 2 /day).

These maximally tolerated doses are 0.8 and 0.1 times, respectively, the daily maximum recommended human dose (MRHD) of 2000 mg on a surface area basis. A published study reported that ranolazine promoted tumor formation and progression to malignancy when given to transgenic APC (min/+) mice at a dose of 30 mg/kg twice daily [see References (15) ]. The clinical significance of this finding is unclear.

In male and female rats, oral administration of ranolazine that produced exposures (AUC) approximately 3-fold or 5-fold higher, respectively, than the MRHD had no effect on fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 184 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Ranolazine tested negative for genotoxic potential in the following assays: Ames bacterial mutation assay, Saccharomyces assay for mitotic gene conversion, chromosomal aberrations assay in Chinese hamster ovary (CHO) cells, mammalian CHO/HGPRT gene mutation assay, and mouse and rat bone marrow micronucleus assays. There was no evidence of carcinogenic potential in mice or rats. The highest oral doses used in the carcinogenicity studies were 150 mg/kg/day for 21 months in rats (900 mg/m 2 /day) and 50 mg/kg/day for 24 months in mice (150 mg/m 2 /day).

These maximally tolerated doses are 0.8 and 0.1 times, respectively, the daily maximum recommended human dose (MRHD) of 2000 mg on a surface area basis. A published study reported that ranolazine promoted tumor formation and progression to malignancy when given to transgenic APC (min/+) mice at a dose of 30 mg/kg twice daily [see References (15) ]. The clinical significance of this finding is unclear.

In male and female rats, oral administration of ranolazine that produced exposures (AUC) approximately 3-fold or 5-fold higher, respectively, than the MRHD had no effect on fertility.

📚 References 23 words ▾

15 REFERENCES M.A. Suckow et al. The anti-ischemia agent ranolazine promotes the development of intestinal tumors in APC (min/+) mice. Cancer Letters 209(2004):165–9.

📄 Patient Package Insert ~3 min read ▾

Patient Information Ranolazine extended-release tablets Dosing Strengths: 500 mg tablets 1000 mg tablets Read this Patient Information before you start taking Ranolazine extended-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

What are Ranolazine extended-release tablets? Ranolazine extended-release tablets are prescription medicine used to treat angina that keeps coming back (chronic angina). Ranolazine extended-release tablets may be used with other medicines that are used for heart problems and blood pressure control.

It is not known if Ranolazine extended-release tablets are safe and effective in children. Who should not take Ranolazine extended-release tablets? Do not take Ranolazine extended-release tablets if: 1. you take any of the following medicines: 1. for fungus infection: ketoconazole (Nizoral ® ), itraconazole (Sporanox ® , Onmel™) 2. for infection: clarithromycin (Biaxin ® ) 3. for depression: nefazodone 4. for HIV: nelfinavir (Viracept ® ), ritonavir (Norvir ® ), lopinavir and ritonavir (Kaletra ® ), indinavir (Crixivan ® ), saquinavir (Invirase ® ) 5. for tuberculosis (TB): rifampin (Rifadin ® ), rifabutin (Mycobutin ® ), rifapentine (Priftin ® ) 6. for seizures: phenobarbital, phenytoin (Phenytek ® , Dilantin ® , Dilantin125 ® ), carbamazepine (Tegretol ® ) 7.

St. John's wort (Hypericum perforatum) 2. you have scarring (cirrhosis) of your liver What should I tell my doctor before taking Ranolazine extended-release tablets? Before you take Ranolazine extended-release tablets, tell your doctor if you: 1. have or have a family history of a heart problem, called 'QT prolongation' or 'long QT syndrome'.

2. have liver problems 3. have kidney problems 4. are pregnant or plan to become pregnant. It is not known if Ranolazine extended-release tablets will harm your unborn baby. 5. are breast-feeding or plan to breast-feed.

It is not known if Ranolazine passes into your breast milk. You and your doctor should decide if you will breast-feed. Tell your doctor about all the medicines you take, including all prescription and nonprescription medicines, vitamins, and herbal supplements.

Ranolazine extended-release tablets may affect the way other medicines work and other medicines may affect how Ranolazine extended-release tablets works. Tell your doctor if you take medicines: 1. for your heart 2. for cholesterol 3. for diabetes 4. for infection 5. for fungus 6. for transplant 7. for nausea and vomiting because of cancer treatments 8. for mental problems Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

How should I take Ranolazine extended-release tablets? 1. Take Ranolazine extended-release tablets exactly as your doctor tells you.

2. Your doctor will tell you how much Ranolazine extended-release tablets to take and when to take it. 3.

Do not change your dose unless your doctor tells you to. 4. Tell your doctor if you still have symptoms of angina after starting Ranolazine extended-release tablets.

5. Take Ranolazine extended-release tablets by mouth, with or without food. 6.

Swallow the Ranolazine extended-release tablets whole. Do not crush, break, or chew Ranolazine extended-release tablets before swallowing. 7.

If you miss a dose of Ranolazine extended-release tablets, wait to take the next dose of Ranolazine extended-release tablets at your regular time. Do not make up for the missed dose. Do not take more than 1 dose at a time.

8. If you take too much Ranolazine extended-release tablets, call your doctor, or go to the nearest emergency room right away. What should I avoid while taking Ranolazine extended-release tablets?

1. Grapefruit and grapefruit juice. Limit products that have grapefruit in them.

They can cause your blood levels of Ranolazine extended-release tablets to increase. 2. Ranolazine extended-release ta… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 64 words ▾

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label NDC 71205-867-78 Rx Only Ranolazine Extended-Release Tablets 500 mg Swallow Ranolazine Extended-Release tablets whole; do not crush, break, or chew. 180 Tablets 71205-867-78

PRINCIPAL DISPLAY PANEL - 1000 mg Tablet Bottle Label NDC 71205-868-78 Rx Only Ranolazine Extended-Release Tablets 1000 mg Swallow Ranolazine Extended-Release tablets whole; do not crush, break, or chew. 180 Tablets 71205-868-78

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ranolazine ER (matched by generic name) — the program that covers self-administered drugs. 16 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ranolazine ER. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$22.88M
Claims incl. refills
332.4K
Beneficiaries
221.5K
Spend / beneficiary
$103.31
Spend / claim
$68.83
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 30 tablets (71205-0868-30), 60 tablets (71205-0868-60), 90 tablets (71205-0868-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71205-0867-00 · Proficient 71205-0869-00 · Proficient →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.