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ASPRUZYO SPRINKLE Ranolazine 500 mg Granule, 1 granule — NDC 47335-0624-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ASPRUZYO SPRINKLE Ranolazine 500 mg Granule, 1 granule — NDC 47335-624-11 (Billing 47335-0624-11)

by SUN PHARMACEUTICAL INDUSTRIES, INC. · 1 GRANULE in 1 PACKET

This is a package of 1 granule of ASPRUZYO SPRINKLE Ranolazine 500 mg Granule from SUN PHARMACEUTICAL INDUSTRIES, INC., no longer marketed, no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 3 package sizes.

NDC 47335-0624-11
🏷️ FDA NDC (as labeled) 47335-624-11 billing pads the product segment with a zero
This package
Contains1 granule Pack sizes3 compare ↓
Main listing for product 47335-624 · Also comes in: 30 granules 47335-624-30 60 granules 47335-624-60
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 14, 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

NDC database record

One package, one record: these facts belong to NDC 47335-624-11 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
47335 labeler · 624 product · 11 package
Billing quantity
1 EA per package
Barcode (UPC-A, from the NDC)
3 4733562411 3
FDA record last changed
Jul 14, 2026
⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Apr 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 47335-624-11
Product NDC 47335-624
11-digit billing NDC 47335062411
NCPDP billing unit EA — each (per item)
Application # NDA216018
SPL Set ID dd9f81e4-50da-4551-aed5-559d304df42e
Mechanism of action Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Apr 2024)
Route ORAL
Dosage form GRANULE
Substance RANOLAZINE
Why two NDCs? The FDA registers this code as 47335-624-11 — 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 → 47335-0624-11. 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.

Clinical

📗 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 gPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 granules 60 granules
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
47335-0624-11 You're viewing this Main listing 1 GRANULE in 1 PACKET 2022-02-28 — Discontinued by firm
47335-0624-30 47335-624-30 30 GRANULE in 1 CARTON 2022-02-28 — Discontinued by firm
47335-0624-60 47335-624-60 60 GRANULE in 1 CARTON 2022-02-28 — Discontinued by firm

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 1 granule — 1 granule in 1 packet.
How does this package differ from NDC 47335-0624-30?
Both are ASPRUZYO SPRINKLE Ranolazine 500 mg Granule — the drug itself is identical. This page's package is the 1 granule one, while NDC 47335-0624-30 is the 30 granules package.
What NDC number is used to bill for this package of ASPRUZYO SPRINKLE Ranolazine 500 mg Granule?
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
Aspruzyo Sprinkle 500 mgthis 47335-0624-11 SUN 1 granule — — Discontinued —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2022
First FDA approval
Feb 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2038
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2038. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 28, 2022 RLD RS ⏳ ~11.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11510878 — drug product
US 12161761 — drug product
US 10898444 — drug product
US 11510878 — drug product
2022 2024 2026 2028 2030 2032 2034 2036 2038
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 11510878 ↗ Drug product — Jan 24, 2038
US 12161761 ↗ Drug product — Jan 24, 2038
US 10898444 ↗ Drug product — Jan 24, 2038
US 11510878 ↗ Drug product — Jan 24, 2038
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2038 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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 white
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 4W5IH7FLNY
    A clear, oily liquid derived from sebacic acid and butanol. It works as a plasticizer and solvent in pharmaceutical coatings and films, helping them stay flexible and smooth.
  • UNII 905HNO1SIH
    A synthetic polymer made from methacrylate compounds that forms a film coating on tablets or capsules. It helps control how quickly the medicine dissolves and releases its active ingredient in the digestive system.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerSUN PHARMACEUTICAL INDUSTRIES, INC.
Application holderSUN PHARMA INDUSTRIES LTD
FDA applicationNDA216018 (NDA)
Labeler code47335
Product typeHuman Prescription Drug
Portfolio890 products on file

More NDCs from SUN PHARMACEUTICAL INDUSTRIES, INC. labeler code 47335

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 📋 Description 💬 Information for Patients 💬 Patient Medication Information 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 48 words ▾

1 INDICATIONS AND USAGE ASPRUZYO Sprinkle is indicated for the treatment of chronic angina. ASPRUZYO Sprinkle may be used with beta-blockers, nitrates, calcium channel blockers, anti‑platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. ASPRUZYO Sprinkle is an antianginal indicated for the treatment of chronic angina. (1)

⏱️ Dosage and Administration ~1 min read ▾

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

2.1Dosing Information Initiate ASPRUZYO Sprinkle dosing at 500 mg orally twice daily and increase to 1000 mg orally twice daily, as needed, based on clinical symptoms. The maximum recommended daily dose of ASPRUZYO Sprinkle is 1000 mg twice daily. If a dose of ASPRUZYO Sprinkle is missed, take the prescribed dose at the next scheduled time; do not double the next dose.

Directions for use with soft food (e.g., applesauce and yogurt) Sprinkle granules on one tablespoonful of soft food and consume immediately. Do not crush or chew the granules. Direction for nasogastric and gastric tube administration Nasogastric (NG) tube: Add the content of a sachet to a plastic catheter tip syringe and add 50 mL of water.

Gently shake the syringe for approximately 15 seconds. Promptly deliver through a 12 French or larger NG tube. Ensure no granules are left in the syringe.

Rinse with additional water (about 15 mL) if needed. Gastrostomy/Gastric (G) tube : Add the content of a sachet to a plastic catheter tip syringe and add 30 mL of water. Gently shake the syringe for approximately 15 seconds.

Promptly deliver through a 12 French or larger G-tube. Rinse with 20 mL of water in the syringe. Ensure no granules are left in the syringe.

Rinse with additional water (about 15 mL) if needed.

2.2Dose Modification Dose adjustments may be needed when ASPRUZYO Sprinkle is taken in combination with other drugs [see Drug Interactions (7.1)]. Limit the maximum dose of ASPRUZYO Sprinkle to 500 mg twice daily in patients on moderate CYP3A inhibitors such as diltiazem, verapamil, and erythromycin. Use of ASPRUZYO Sprinkle with strong CYP3A inhibitors and CYP3A inducers is contraindicated [see Contraindications (4), Drug Interactions (7.1)].

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS AND STRENGTHS ASPRUZYO Sprinkle (ranolazine) is supplied as unit-dose sachets containing 500 or 1000 mg of white to off-white, coated, extended-release granules. Extended-release granules: 500 and 1000 mg (3)

⛔ Contraindications 57 words ▾

4 CONTRAINDICATIONS ASPRUZYO Sprinkle is contraindicated in patients: Taking strong inhibitors of CYP3A [see Drug Interactions (7.1)] Taking inducers of CYP3A [see Drug Interactions (7.1)] With liver cirrhosis [see Use in Specific Populations (8.6)] Strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, nelfinavir) (4, 7.1) CYP3A inducers (e.g., rifampin, phenobarbital, St. John's wort) (4, 7.1) Liver cirrhosis (4, 8.6)

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS QT interval prolongation: Can occur with ranolazine. Little information 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) 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 ASPRUZYO Sprinkle. (5.2)

5.1QT Interval Prolongation Ranolazine blocks I Kr and prolongs the QT c 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 patients with severe renal impairment (creatinine clearance [CrCL] < 30 mL/min) while taking ranolazine. If acute renal failure develops (e.g., marked increase in serum creatinine associated with an increase in blood urea nitrogen [BUN]), discontinue ASPRUZYO Sprinkle 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 ~3 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 Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 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, 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 in open-label, long-term studies; 1227 patients were exposed to ranolazine 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 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 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 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 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 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, but there was no apparent proarrhythmic effect in these high-risk patients [see Clinical Studies (14.2)]. Laboratory Abnormalities : Ranolazine 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, and is not accompanied by changes in BUN.

In healthy volunteers, ranolazine 1000 mg twice daily had no effect upon the glomerular filtration rate. More marked and progressive increases in serum creatinine, associated with increases in BUN or potassium, indica… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin): Limit ASPRUZYO Sprinkle to 500 mg twice daily. (7.1) P-gp inhibitors (e.g., cyclosporine): Ranolazine exposure increased. Titrate ASPRUZYO Sprinkle based on clinical response.

(7.1) CYP3A substrates: Limit simvastatin to 20 mg when used with ASPRUZYO Sprinkle. 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 ASPRUZYO Sprinkle. (7.2) OCT2 substrates: Limit the dose of metformin to 1700 mg daily when used with ASPRUZYO Sprinkle 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 ASPRUZYO Sprinkle. (7.2)

7.1Effects of Other Drugs on Ranolazine Strong CYP3A Inhibitors Concomitant use of ASPRUZYO Sprinkle with strong CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir is contraindicated [see Contraindications (4), Clinical Pharmacology (12.3)]. Moderate CYP3A Inhibitors Limit the dose of ASPRUZYO Sprinkle 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 ASPRUZYO Sprinkle and P-gp inhibitors, such as cyclosporine, may result in increases in ranolazine concentrations. Titrate ASPRUZYO Sprinkle based on clinical response in patients concomitantly treated with predominant P-gp inhibitors such as cyclosporine [see Dosage and Administration (2.2)]. CYP3A Inducers Concomitant use of ASPRUZYO Sprinkle with CYP3A inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St.

John's wort is contraindicated [see Contraindications (4), Clinical Pharmacology (12.3)]. Alcohol An in-vitro dissolution study was conducted to evaluate the impact of alcohol on extended-release characteristics of ASPRUZYO Sprinkle. The in-vitro study showed that alcohol causes a rapid release of ranolazine from ASPRUZYO Sprinkle that may increase the risk of adverse events associated with ASPRUZYO Sprinkle.

Patients should not consume alcohol when taking ASPRUZYO Sprinkle [see 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 ASPRUZYO Sprinkle to 20 mg once daily, when ASPRUZYO Sprinkle 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 ASPRUZYO Sprinkle may increase plasma concentrations of these drugs [see Clinical Pharmacology (12.3)]. Drugs Transported by P-gp Concomitant use of ASPRUZYO Sprinkle 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 ASPRUZYO Sprinkle, and lower doses of these drugs may be required. Drugs Transported by OCT2 In subjects with type 2 diabetes mellitus, concomitant use of ASPRUZYO Sprinkle 1000 mg twice daily and metformin results in increased plasma levels of metformin.

When ASPRUZYO Sprinkle 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 500 mg twice daily [see Clinical Pharmacolog… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on ranolazine 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 and any potential adverse effects on the breastfed infant from ranolazine 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 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, 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 ASPRUZYO Sprinkle is 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 200% 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 in subjects with severe renal impairment (CrCL< 30 mL/min) was stopped when 2 of 4 subjects developed acute renal failure after receiving ranolazine 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. One subject required hemodialysis, while the other 2 subjects improved upon drug discontinuation [s ee Warnings and Precautions (5.2)].

Monitor renal function periodically in patients with moder… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 134 words ▾

8.1Pregnancy Risk Summary There are no available data on ranolazine 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 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, 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 88 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. In cases of extreme overdose of ranolazine 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 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 QT c 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.

These effects are believed to be caused by ranolazine and not by its metabolites. The relationship between the change in QT c 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 QT c .

At T max following repeat dosing at 1000 mg twice daily, the mean change in QT c is about 6 msec, but in the 5% of the population with the highest plasma concentrations, the prolongation of QT c is at least 15 msec. In cirrhotic subjects with mild or moderate hepatic impairment, the relationship between plasma level of ranolazine and QT c 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 QT c -concentration relationship of ranolazine.

No proarrhythmic effects were observed on 7-day Holter recordings in 3,162 acute coronary syndrome patients treated with ranolazine. There was a significantly lower incidence of arrhythmias (ventricular tachycardia, bradycardia, supraventricular tachycardia, and new atrial fibrillation) in patients treated with ranolazine (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 The pharmacokinetic parameter of ranolazine after single dose administration of 1000 mg ASPRUZYO Sprinkle under fasting conditions are summarized in table 1. Table 1: Pharmacokinetic parameters of ranolazine after single dose administration of 1000 mg ASPRUZYO Sprinkle under fasting conditions. Parameter ASPRUZYO Sprinkle Mean CV (%) C max (mcg/mL) 1.95 30 T max (hr) * 10 (2 to 16) AUC 0-t (mcg.hr/mL) 31.4 36 AUC 0-∞ (mcg.hr/mL) 31.7 36 T 1/2 (hr) 5.3 27 Kel (hr -1 ) 0.15 29 *Median range (min-max) is provided Ranolazine is extensively metabolized in the gut and liver and its absorption is highly variable.

The pharmacokinetics of the (+) R-and (-) S-enantiomers of ranolazine are similar in healthy volunteers. Steady state is generally achieved within 3 days of twice-daily dosing with ranolazine. 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, 120% and 140%, respectively.

With twice-daily dosing, the trough:peak ratio of the ranolazine plasma concentration is 0.3 to 0.6. The pharmacokinetics o… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 98 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 97 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ASPRUZYO Sprinkle is supplied as white to off-white coated, extended-release granules in sachets of 500 or 1000 mg. Packages are Strength NDC Unit-dose Sachet (Child-resistant) 500 mg NDC 47335-624-11 Unit-dose Sachet (Child-resistant) 1000 mg NDC 47335-625-11 30 Unit-dose Sachets (Child-resistant) 500 mg NDC 47335-624-30 30 Unit-dose Sachets (Child-resistant) 1000 mg NDC 47335-625-30 60 Unit-dose Sachets (Child-resistant) 500 mg NDC 47335-624-60 60 Unit-dose Sachets (Child-resistant) 1000 mg NDC 47335-625-60 Store ASPRUZYO Sprinkle at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

📋 Description 109 words ▾

11 DESCRIPTION ASPRUZYO Sprinkle contains ranolazine, an antianginal available as white to off-white coated extended-release granules filled in a sachet 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 a molecular 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 off-white to white powder.

Ranolazine is soluble in dichloromethane and methanol. ASPRUZYO Sprinkle contains 500 mg or 1000 mg of ranolazine and the following inactive ingredients: amino methacrylate copolymer, dibutyl sebacate, ethyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, and talc. structural-formula

💬 Information for Patients 213 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients that ASPRUZYO Sprinkle will not abate an acute angina episode. Drug Interactions Advise patients to discuss with their healthcare provider any prescription or over-the-counter medications and supplements prior to concomitant use [see Drug Interactions (7)].

Advise patients to limit grapefruit juice or grapefruit products when taking ASPRUZYO Sprinkle [see Drug Interactions (7)] . QT Interval Prolongation Advise patients to inform their physician of any personal or family history of QT c prolongation, congenital long QT syndrome, or if they are receiving drugs that prolong the QT c interval such as [see Warnings and Precautions (5.1)]. Dizziness, Fainting Inform patients that ASPRUZYO Sprinkle may cause dizziness and lightheadedness.

Patients should know how they react to ASPRUZYO Sprinkle before they operate an automobile or machinery, or engage in activities requiring mental alertness or coordination [see Adverse Reactions (6.1)]. Advise patients to contact their physician if they experience fainting spells while taking ASPRUZYO Sprinkle. Administration Instruct patients to take ASPRUZYO Sprinkle as directed.

Advise patients not to crush or chew the granules. All trademarks are the property of their respective owners. Manufactured by: Sun Pharmaceutical Industries Ltd.

Mohali, INDIA Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 FDA-04

💬 Patient Medication Information ~3 min read ▾

Patient Medication Information Patient Information ASPRUZYO Sprinkle (as-PROO-zee-oh spring-KUHL) (ranolazine) extended-release granules What is ASPRUZYO Sprinkle? ASPRUZYO Sprinkle is a prescription medicine used to treat angina that keeps coming back (chronic angina). ASPRUZYO Sprinkle may be used with other medicines that are used for heart problems and blood pressure control.

It is not known if ASPRUZYO Sprinkle is safe and effective in children. Do not take ASPRUZYO Sprinkle if: you take any of the following medicines: for fungus infection: ketoconazole, itraconazole for infection: clarithromycin for depression: nefazodone for HIV: nelfinavir, ritonavir, indinavir saquinavir for tuberculosis (TB): rifampin, rifabutin, rifapentine for seizures: phenobarbital, phenytoin, and carbamazepine St. John's wort you have scarring of your liver (liver cirrhosis) Before taking ASPRUZYO Sprinkle, tell your healthcare provider about all of your medical conditions, including if you: have or have a family history of a heart problem, called 'QT prolongation' or 'long QT syndrome' have liver problems have kidney problems are pregnant or plan to become pregnant.

It is not known if ASPRUZYO Sprinkle will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ranolazine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ASPRUZYO Sprinkle may affect the way other medicines work and other medicines may affect how ASPRUZYO Sprinkle works. Know the medicines you take.

Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. How should I take ASPRUZYO Sprinkle? Take ASPRUZYO Sprinkle exactly as your healthcare provider tells you.

Your healthcare provider will tell you how much ASPRUZYO Sprinkle to take and when to take it. Do not change your dose unless your healthcare provider tells you to. Tell your healthcare provider if you still have symptoms of angina after starting ASPRUZYO Sprinkle.

Take ASPRUZYO Sprinkle 2 times a day. ASPRUZYO Sprinkle may be taken or given as follows: To open the sachet fold back on dotted line and tear at notch or use scissors. Directions for use with soft food (e.g., applesauce and yogurt): Sprinkle granules on one tablespoonful of soft food and consume immediately.

Do not crush or chew the granules. Giving ASPRUZYO Sprinkle with water through a 12 French or larger nasogastric (NG) tube : Add the granules from the sachet to a plastic catheter tip syringe and add 50 mL of water. Gently shake the syringe for about 15 seconds.

Connect the catheter tip syringe to the NG tube and give the mixture right away. Make sure that no granules are left in the syringe. Rinse the syringe with about 15 mL of additional water if needed and give through NG tube.

Giving ASPRUZYO Sprinkle with water through a 12 French or larger gastric (G) tube: Add the granules from the sachet to a plastic catheter tip syringe and add 30 mL of water. Gently shake the syringe for about 15 seconds. Connect the catheter tip syringe to the G-tube and give the mixture right away.

Rinse the syringe with 20 mL of additional water and give through G-tube. Make sure that no granules are left in the syringe. Rinse the syringe with about 15 mL of additional water if needed and give through G-tube.

If you miss a dose of ASPRUZYO Sprinkle, take the next dose of ASPRUZYO Sprinkle at your regular time. Do not make up for the missed dose. Do not take 2 doses at the same time.

If you take too much ASPRUZYO Sprinkle, call your healthcare provider, or go to the nearest emergency room right away. What should I avoid while taking ASPRUZYO Sprinkle? You should limit grapefruit, grapefruit juice, and products that contain grapefruit during treatment with ASPRUZYO Sprinkle.

Grapefruit products can increase the a… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetic parameter of ranolazine after single dose administration of 1000 mg ASPRUZYO Sprinkle under fasting conditions are summarized in table 1. Table 1: Pharmacokinetic parameters of ranolazine after single dose administration of 1000 mg ASPRUZYO Sprinkle under fasting conditions. Parameter ASPRUZYO Sprinkle Mean CV (%) C max (mcg/mL) 1.95 30 T max (hr) * 10 (2 to 16) AUC 0-t (mcg.hr/mL) 31.4 36 AUC 0-∞ (mcg.hr/mL) 31.7 36 T 1/2 (hr) 5.3 27 Kel (hr -1 ) 0.15 29 *Median range (min-max) is provided Ranolazine is extensively metabolized in the gut and liver and its absorption is highly variable.

The pharmacokinetics of the (+) R-and (-) S-enantiomers of ranolazine are similar in healthy volunteers. Steady state is generally achieved within 3 days of twice-daily dosing with ranolazine. 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, 120% and 140%, 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 and sex. Absorption and Distribution After oral administration of ranolazine 1000 mg, median T max was 10 hours under fasting conditions and 4.5 to 6 hours under fed.

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 granules 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.

Over the concentration range of 0.25 to 10 mcg/mL, ranolazine is approximately 62% bound to human plasma proteins. Food Effect Compared to the fasted state, the systemic exposure (AUC) increased by 10% and peak drug concentration (C max ) increased by 27% when the dose was given 30 minutes after a high fat meal. After administration with a low fat low calorie meal AUC increased by 6% and C max increased by 48%.

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. The mean elimination half-lives of ranolazine is approximately 5 hours post single dose ranging from 2 to 11 hours. 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 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 1000 mg twice daily are increased by 50 to 130% by diltiazem 180 to 360 mg, respectively. Plasma levels of ranolazine with ranolazine 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 ranolazi… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Hemodynamic Effects Patients with chronic angina treated with ranolazine 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 QT c 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.

These effects are believed to be caused by ranolazine and not by its metabolites. The relationship between the change in QT c 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 QT c .

At T max following repeat dosing at 1000 mg twice daily, the mean change in QT c is about 6 msec, but in the 5% of the population with the highest plasma concentrations, the prolongation of QT c is at least 15 msec. In cirrhotic subjects with mild or moderate hepatic impairment, the relationship between plasma level of ranolazine and QT c 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 QT c -concentration relationship of ranolazine.

No proarrhythmic effects were observed on 7-day Holter recordings in 3,162 acute coronary syndrome patients treated with ranolazine. There was a significantly lower incidence of arrhythmias (ventricular tachycardia, bradycardia, supraventricular tachycardia, and new atrial fibrillation) in patients treated with ranolazine (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 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 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 2. Exercise treadmill results showed no increase in effect on exercise at the 1000 mg dose compared to the 750-mg dose. Table 2 Exercise Treadmill Results (CARISA) Mean Difference from Placebo (sec) Study CARISA (N = 791) Ranolazine Twice-daily Dose 750 mg 1000 mg Exercise Duration Trough Peak 24 a 34 b 24 a 26 a Time to Angina Trough Peak 30 a 38 b 26 a 38 b Time to 1 mm ST-Segment Depression Trough Peak 20 41 b 21 35 b a p-value ≤ 0.05 b p-value ≤ 0.005 The effects of ranolazine on angina frequency and nitroglycerin use are shown in Table 3.

Table 3 Angina Frequency and Nitroglycerin Use (CARISA) Placebo Ranolazine 750 mg a Ranolazine 1000 mg a 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 a Twice daily Tolerance to ranolazine 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. Ranolazine 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 500 mg twice daily or placebo for 1 week, followed by 6 weeks of treatment with ranolazine 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 4. Statistically significant decreases in angina attack frequency (p = 0.028) and nitroglycerin use (p = 0.014) were observed with ranolazine compared to placebo. These treatment effects appeared consistent across age and use of long-acting nitrates.

Table 4 Angina Frequency and Nitroglycerin Use (ERICA) Placebo Ranolazine a 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 1.3 a 1000 mg twice daily Gender 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 measures. However, the study is somewhat reassuring regarding proarrhythmic risks, as ventricular arrhythmias were less common on ranolazine [see Clinical Pharmacology (12.2)], and there was no difference between ranolazine and placebo in the risk of all-cause mortality (relative risk… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 184 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 2,000 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 . 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 181 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 2,000 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 . 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.

📄 Package Label / Principal Display Panel 89 words ▾

Package/Label Display Panel NDC 47335-624-30 ASPRUZYO Sprinkle™ (ranolazine) extended-release granules 500 mg per sachet Rx only SUN PHARMA Contains 30 sachets spl-aspruzyo-500 mg-30 carton

Package/Label Display Panel NDC 47335-624-60 ASPRUZYO Sprinkle™ (ranolazine) extended-release granules 500 mg per sachet Rx only SUN PHARMA Contains 60 sachets spl-aspruzyo-500 mg-60 carton

Package/Label Display Panel NDC 47335-624-11 ASPRUZYO Sprinkle™ (ranolazine) extended-release granules 500 mg per sachet Each sachet contains 500 mg ranolazine Recommended Dosage: See prescribing information. Rx only SUN PHARMA This package is child-resistant. Keep out of reach of children. spl-aspruzyo-sachet-500 mg

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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ASPRUZYO SPRINKLE (this brand).

Top reported reactions

Death826
Myocardial Infarction646
Chest Pain614
Angina Pectoris595
Stent Placement582
Dyspnoea439
Dizziness427

Age at onset

Neonate3
Infant16
Child1
Adolescent2
Adult1,878
Elderly4,639

Reporter sex

10,376 reports
Male · 59%
Female · 41%
Unknown · 0%

Serious outcomes

Hospitalization4,453
Death1,337
Disabling347
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 983 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) ✓ 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 granules (47335-0624-30), 60 granules (47335-0624-60). 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?
SUN PHARMACEUTICAL INDUSTRIES, INC. 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.
← 47335-0619-10 · SUN 47335-0625-11 · SUN →
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.