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rivaroxaban 10 mg Tablet, Film Coated, 30-count — NDC 55488-0540-01 package photo

rivaroxaban 10 mg Tablet, Film Coated, 30-count

by Changzhou Pharmaceutical Factory · 30 TABLET, FILM COATED in 1 BOTTLE (55488-0540-1)
NDC 55488-0540-01
🏷️ FDA NDC (as labeled) 55488-0540-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 55488-0540-1
Product NDC 55488-0540
11-digit billing NDC 55488054001
RxCUI 1114198, 1232082, 1232086
UNII 9NDF7JZ4M3
UPC 0355488054114, 0355488054015, 0355488054213
Application # ANDA216995
SPL Set ID 9178947d-9d58-4c1a-b158-6030e17556af
Established class (EPC) Factor Xa Inhibitor
Mechanism of action Factor Xa Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance RIVAROXABAN
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 55488-0540-1 — a 5-4-1 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 package segment → 55488-0540-01. 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 Factor Xa Inhibitor class.

Pharmacologic class Factor Xa Inhibitor
Drug family (ATC) Direct factor Xa inhibitors
How it works Factor Xa 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.

🏭 Manufacturer & labeler

LabelerChangzhou Pharmaceutical Factory
Application holderAIPING PHARMACEUTICAL INC
FDA applicationANDA216995 (ANDA)
Labeler code55488
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio11 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.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Rivaroxaban is used to: prevent and treat deep vein thrombosis (DVT; a blood clot) and pulmonary embolism (PE; a blood clot in the lung). lower the risk of a heart attack, stroke, or death in people with coronary artery disease (narrowing of the blood vessels that bring blood to the heart) or peripheral arterial disease (poor blood flow to the arms and legs). Rivaroxaban is in a class of medications called factor Xa inhibitors. It works by blocking a natural substance that helps blood clots to form.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes, rivaroxaban is a blood thinner, but it covers a pretty wide range of conditions. It's used to treat blood clots in the legs (DVT) and lungs (pulmonary embolism), prevent those...
  • What exactly is rivaroxaban used for — is it just a blood thinner?
  • It depends on the strength you've been prescribed. Certain higher-strength tablets need to be taken with food — food helps your body absorb enough of the medication. Lower-strength...
  • Do I need to take rivaroxaban with food?
📖 Read our full Rivaroxaban 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.

💊 What it looks like

Color pink / red / yellow
ShapeRound
Imprint20
Size6 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.

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

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 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 G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 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.

💲 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 · 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.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rivaroxaban 10 mg 14445-0148-10 Indoco 10 tablets — AB FDA listed —
Rivaroxaban 10 mg 46708-0346-10 Alembic 10 tablets — AB FDA listed —
Xarelto 10 mg 50090-3625-00 A-S 90 tablets — AB FDA listed —
Xarelto 10 mg 50090-4469-00 A-S 90 tablets — AB FDA listed —
Xarelto 10 mg 50458-0580-07 Janssen 7 tablets — AB FDA listed —
Xarelto 10 mg 55154-1422-00 Cardinal 1 tablet — AB Discontinued —
rivaroxaban 10 mgthis 55488-0540-01 Changzhou 30 tablets — AB FDA listed —
Rivaroxaban 10 mg 62332-0346-10 Alembic 10 tablets — AB FDA listed —
Xarelto 10 mg 71610-0690-42 Aphena 1800 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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

Medicare Part D (outpatient prescription) spending for Rivaroxaban — the program that covers self-administered drugs. 12 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 Rivaroxaban. 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
$25.98M
Claims incl. refills
66.6K
Beneficiaries
42.6K
Spend / beneficiary
$609.07
Spend / claim
$390.13
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55488-0540-01 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (55488-0540-1) 2026-02-01 Active

🧭 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) ✓ 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 FDA registers it as 55488-0540-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 55488-0540-01, written without dashes as 55488054001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 55488-0540-01, the first segment (55488) is the labeler code FDA assigned to Changzhou Pharmaceutical Factory; the middle segment (0540) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Changzhou Pharmaceutical Factory. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Changzhou Pharmaceutical Factory 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 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 💬 Medication Guide
🚨 Boxed Warning ~2 min read ▾

WARNING: (A) PREMATURE DISCONTINUATION OF RIVAROXABAN INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA WARNING: (A) PREMATURE DISCONTINUATION OF RIVAROXABAN INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) Premature discontinuation of rivaroxaban increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including rivaroxaban, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if rivaroxaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy.

( 2.2 , 2.3 , 5.1 , 14.1 ) (B) Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with rivaroxaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. ( 5.2 , 5.3 , 6.2 ) Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently.

Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated. ( 5.3 ) A. Premature discontinuation of rivaroxaban increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including rivaroxaban, increases the risk of thrombotic events.

If anticoagulation with rivaroxaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.3 , 2.4) , Warnings and Precautions (5.1) , and Clinical Studies (14.1) ] . B. Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with rivaroxaban who are receiving neuraxial anesthesia or undergoing spinal puncture.

These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants a history of traumatic or repeated epidural or spinal punctures a history of spinal deformity or spinal surgery optimal timing between the administration of rivaroxaban and neuraxial procedures is not known [see Warnings and Precautions (5.2 , 5.3) and Adverse Reactions (6.2) ].

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.3) ] . Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.3) ] .

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Rivaroxaban is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6 ) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD ( 1.8 ) for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9 ) for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10 )

1.1Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation Rivaroxaban tablets are indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. There are limited data on the relative effectiveness of rivaroxaban and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see Clinical Studies (14.1) ].

1.2Treatment of Deep Vein Thrombosis Rivaroxaban tablets are indicated for the treatment of deep vein thrombosis (DVT).

1.3Treatment of Pulmonary Embolism Rivaroxaban tablets are indicated for the treatment of pulmonary embolism (PE).

1.4Reduction in the Risk of Recurrence of Deep Vein Thrombosis and/or Pulmonary Embolism Rivaroxaban tablets are indicated for the reduction in the risk of recurrence of DVT and/or PE in adult patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months.

1.5Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery Rivaroxaban tablets are indicated for the prophylaxis of DVT, which may lead to PE in adult patients undergoing knee or hip replacement surgery.

1.6Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding Rivaroxaban tablets are indicated for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding [see Warnings and Precautions (5.2) and Clinical Studies (14.5) ] .

1.7Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) Rivaroxaban tablets, in combination with aspirin, are indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease.

1.8Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD Rivaroxaban tablets, in combination with aspirin, are indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.

1.9Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients Rivaroxaban tablets are indicated for the treatment of venous thromboembolism (VTE) and the reduction in the ri…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Nonvalvular Atrial Fibrillation : 15 or 20 mg, once daily with food ( 2.1 ) Treatment of DVT and/or PE : 15 mg orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food for the remaining treatment ( 2.1 ) Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE : 10 mg once daily with or without food, after at least 6 months of standard anticoagulant treatment ( 2.1 ) Prophylaxis of DVT Following Hip or Knee Replacement Surgery : 10 mg orally once daily with or without food ( 2.1 ) Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding : 10 mg once daily, with or without food, in hospital and after hospital discharge for a total recommended duration of 31 to 39 days ( 2.1 ) CAD or PAD : 2.5 mg orally twice daily with or without food, in combination with aspirin (75–100 mg) once daily ( 2.1 ) Pediatric Patients: See dosing recommendations in the Full Prescribing Information ( 2.2 )

2.1Recommended Dosage in Adults Table 1: Recommended Dosage in Adults Indication Renal Considerations Calculate CrCl based on actual weight. [See Warnings and Precautions (5.4) and Use in Specific Populations (8.6) ] Dosage Food/Timing See Clinical Pharmacology (12.3) Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation CrCl >50 mL/min 20 mg once daily Take with evening meal CrCl ≤50 mL/min Patients with CrCl <30 mL/min were not studied, but administration of rivaroxaban tablets is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Use in Specific Populations (8.6) ] 15 mg once daily Take with evening meal Treatment of DVT and/or PE CrCl ≥15 mL/min 15 mg twice daily ▼ after 21 days, transition to ▼ 20 mg once daily Take with food, at the same time each day CrCl <15 mL/min Avoid Use Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE CrCl ≥15 mL/min 10 mg once daily, after at least 6 months of standard anticoagulant treatment Take with or without food CrCl <15 mL/min Avoid Use Prophylaxis of DVT Following: Hip Replacement Surgery See Dosage and Administration (2.4) CrCl ≥15 mL/min 10 mg once daily for 35 days, 6–10 hours after surgery once hemostasis has been established Take with or without food CrCl <15 mL/min Avoid Use Knee Replacement Surgery CrCl ≥15 mL/min 10 mg once daily for 12 days, 6–10 hours after surgery once hemostasis has been established Take with or without food CrCl <15 mL/min Avoid Use Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding CrCl ≥15 mL/min 10 mg once daily, in hospital and after hospital discharge, for a total recommended duration of 31 to 39 days Take with or without food CrCl <15 mL/min Avoid Use Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD No dose adjustment needed based on CrCl 2.5 mg twice daily , plus aspirin (75–100 mg) once daily Take with or without food Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD No dose adjustment needed based on CrCl 2.5 mg twice daily , plus aspirin (75–100 mg) once daily.

When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established. Take with or without food

2.2Recommended Dosage in Pediatric Patients Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients Table 2: Recommended Dosage in Pediatric Patients Birth to Less than 18 Years for Treatment of and Reduction in Risk of Recurrent VTE Initiate rivaroxaban tablets treatment following at least 5 days of initial parenteral anticoagulation therapy. , Patients <6 months of age should…

💊 Dosage Forms and Strengths 75 words ▾

3 DOSAGE FORMS AND STRENGTHS 2.5 mg tablets: Round, white, biconvex and film-coated with “2.5” marked on one side 10 mg tablets: Round, pink, biconvex and film-coated with “10” marked on one side 15 mg tablets: Round, red, biconvex, and film-coated with “15” marked on one side 20 mg tablets: Round, light yellow, biconvex, and film-coated with “20” marked on one side Tablets: 2.5 mg, 10 mg, 15 mg, and 20 mg ( 3 )

⛔ Contraindications 45 words ▾

4 CONTRAINDICATIONS Rivaroxaban tablets are contraindicated in patients with: active pathological bleeding [see Warnings and Precautions (5.2) ] severe hypersensitivity reaction to rivaroxaban (e.g., anaphylactic reactions) [see Adverse Reactions (6.2) ] Active pathological bleeding ( 4 ) Severe hypersensitivity reaction to rivaroxaban ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Risk of bleeding: Rivaroxaban can cause serious and fatal bleeding. An agent to reverse the activity of rivaroxaban is available. ( 5.2 ) Pregnancy-related hemorrhage: Use rivaroxaban with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery.

( 5.7 , 8.1 ) Prosthetic heart valves: Rivaroxaban use not recommended. ( 5.8 ) Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: Rivaroxaban use not recommended. ( 5.10 )

5.1Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including rivaroxaban, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from rivaroxaban to warfarin in clinical trials in atrial fibrillation patients. If rivaroxaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.3 , 2.4) and Clinical Studies (14.1) ] .

5.2Risk of Bleeding Rivaroxaban increases the risk of bleeding, including in any organ, and can cause serious or fatal bleeding. In deciding whether to prescribe rivaroxaban tablets to patients at increased risk of bleeding, the risk of thrombotic events should be weighed against the risk of bleeding. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement.

Discontinue rivaroxaban tablets in patients with active pathological hemorrhage. The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years. Concomitant use of other drugs that impair hemostasis increases the risk of bleeding.

These include aspirin, P2Y 12 platelet inhibitors, dual antiplatelet therapy, other antithrombotic agents, fibrinolytic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions (7.4) ] , selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors. Concomitant use of drugs that are known combined P-gp and strong CYP3A inhibitors increases rivaroxaban exposure and may increase bleeding risk [see Drug Interactions (7.2) ] . Risk of Hemorrhage in Acutely Ill Medical Patients at High Risk of Bleeding Acutely ill medical patients with the following conditions are at increased risk of bleeding with the use of rivaroxaban tablets for primary VTE prophylaxis: history of bronchiectasis, pulmonary cavitation, or pulmonary hemorrhage, active cancer (i.e., undergoing acute, in-hospital cancer treatment), active gastroduodenal ulcer in the three months prior to treatment, history of bleeding in the three months prior to treatment, or dual antiplatelet therapy.

Rivaroxaban tablets are not for use for primary VTE prophylaxis in these hospitalized, acutely ill medical patients at high risk of bleeding. Reversal of Anticoagulant Effect An agent to reverse the anti-factor Xa activity of rivaroxaban is available. Because of high plasma protein binding, rivaroxaban is not dialyzable [see Clinical Pharmacology (12.3) ] .

Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. Use of procoagulant reversal agents, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered but has not been evaluated in clinical efficacy and safety studies. Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity is not recommended.

5.3Spinal/Epidural Anesthesia or Puncture When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed in other sections of the labeling: Increased Risk of Stroke After Discontinuation in Nonvalvular Atrial Fibrillation [see Boxed Warning and Warnings and Precautions (5.1) ] Bleeding Risk [see Warnings and Precautions (5.2 , 5.4 , 5.5 , 5.6 , 5.7) ] Spinal/Epidural Hematoma [see Boxed Warning and Warnings and Precautions (5.3) ] The most common adverse reaction (>5%) in adult patients was bleeding. ( 6.1 ) The most common adverse reactions (>10%) in pediatric patients were bleeding, cough, vomiting, and gastroenteritis.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Changzhou Pharmaceutical Factory at 1-800-947-0391 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials 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 clinical practice. During clinical development for the approved indications, 34,947 adult patients were exposed to rivaroxaban. Hemorrhage The most common adverse reactions with rivaroxaban were bleeding complications [see Warnings and Precautions (5.2) ] .

Nonvalvular Atrial Fibrillation In the ROCKET AF trial, the most frequent adverse reactions associated with permanent drug discontinuation were bleeding events, with incidence rates of 4.3% for rivaroxaban vs. 3.1% for warfarin. The incidence of discontinuations for non-bleeding adverse events was similar in both treatment groups.

Table 5 shows the number of patients experiencing various types of bleeding events in the ROCKET AF trial. Table 5: Bleeding Events in ROCKET AF Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. These events occurred during treatment or within 2 days of stopping treatment. - On Treatment Plus 2 Days Parameter Rivaroxaban N=7111 n (%/year) Warfarin N=7125 n (%/year) Rivaroxaban vs.

Warfarin HR (95% CI) Abbreviations: HR = Hazard Ratio, CI = Confidence interval, CRNM = Clinically Relevant Non-Major. Major Bleeding Defined as clinically overt bleeding associated with a decrease in hemoglobin of ≥2 g/dL, a transfusion of ≥2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome. 395 (3.6) 386 (3.5) 1.04 (0.90, 1.20) Intracranial Hemorrhage (ICH) Intracranial bleeding events included intraparenchymal, intraventricular, subdural, subarachnoid and/or epidural hematoma.

55 (0.5) 84 (0.7) 0.67 (0.47, 0.93) Hemorrhagic Stroke Hemorrhagic stroke in this table specifically refers to non-traumatic intraparenchymal and/or intraventricular hematoma in patients on treatment plus 2 days. 36 (0.3) 58 (0.5) 0.63 (0.42, 0.96) Other ICH 19 (0.2) 26 (0.2) 0.74 (0.41, 1.34) Gastrointestinal (GI) Gastrointestinal bleeding events included upper GI, lower GI, and rectal bleeding. 221 (2.0) 140 (1.2) 1.61 (1.30, 1.99) Fatal Bleeding Fatal bleeding is adjudicated death with the primary cause of death from bleeding.

27 (0.2) 55 (0.5) 0.50 (0.31, 0.79) ICH 24 (0.2) 42 (0.4) 0.58 (0.35, 0.96) Non-intracranial 3 (0.0) 13 (0.1) 0.23 (0.07, 0.82) Figure 1 shows the risk of major bleeding events across major subgroups. Note: The figure above presents effects in various subgroups all of which are baseline characteristics and all of which were pre-specified (diabetic status was not pre-specified in the subgroup but was a criterion for the CHADS2 score). The 95% confidence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors.

Apparent homogeneity or heterogeneity among groups should not be over-interpreted. Figure 1: Risk of Major Bleeding Events by Baseline Characteristics in ROCKET AF –…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Avoid combined P-gp and strong CYP3A inhibitors and inducers ( 7.2 , 7.3 ) Anticoagulants: Avoid concomitant use ( 7.4 )

7.1General Inhibition and Induction Properties Rivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding cassette G2 (ABCG2) transporters. Combined P-gp and strong CYP3A inhibitors increase exposure to rivaroxaban and may increase the risk of bleeding. Combined P-gp and strong CYP3A inducers decrease exposure to rivaroxaban and may increase the risk of thromboembolic events.

7.2Drugs that Inhibit Cytochrome P450 3A Enzymes and Drug Transport Systems Interaction with Combined P-gp and Strong CYP3A Inhibitors Avoid concomitant administration of rivaroxaban with known combined P-gp and strong CYP3A inhibitors (e.g., ketoconazole and ritonavir) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3) ] . Although clarithromycin is a combined P-gp and strong CYP3A inhibitor, pharmacokinetic data suggests that no precautions are necessary with concomitant administration with rivaroxaban as the change in exposure is unlikely to affect the bleeding risk [see Clinical Pharmacology (12.3) ] .

Interaction with Combined P-gp and Moderate CYP3A Inhibitors in Patients with Renal Impairment Rivaroxaban should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A inhibitors (e.g., erythromycin) unless the potential benefit justifies the potential risk [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ] .

7.3Drugs that Induce Cytochrome P450 3A Enzymes and Drug Transport Systems Avoid concomitant use of rivaroxaban with drugs that are combined P-gp and strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3) ] .

7.4Anticoagulants and NSAIDs/Aspirin Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3) ]. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk unless benefit outweighs risk. Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs [see Warnings and Precautions (5.2) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Renal impairment: Avoid or adjust dose ( 8.6 ) Hepatic impairment: Avoid use in Child-Pugh B and C hepatic impairment or hepatic disease associated with coagulopathy ( 8.7 )

8.1Pregnancy Risk Summary The limited available data on rivaroxaban in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use rivaroxaban tablets with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of rivaroxaban cannot be reliably monitored with standard laboratory testing.

Consider the benefits and risks of rivaroxaban for the mother and possible risks to the fetus when prescribing rivaroxaban tabkets to a pregnant woman [see Warnings and Precautions (5.2 , 5.7) ] . Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnancy is a risk factor for venous thromboembolism and that risk is increased in women with inherited or acquired thrombophilias. Pregnant women with thromboembolic disease have an increased risk of maternal complications including pre-eclampsia.

Maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption and early and late pregnancy loss. Fetal/Neonatal Adverse Reactions Based on the pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate. Labor or Delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding and this risk may be increased during labor or delivery [see Warnings and Precautions (5.7) ].

The risk of bleeding should be balanced with the risk of thrombotic events when considering the use of rivaroxaban tablets in this setting. Data Human Data There are no adequate or well-controlled studies of rivaroxaban in pregnant women, and dosing for pregnant women has not been established. Post-marketing experience is currently insufficient to determine a rivaroxaban-associated risk for major birth defects or miscarriage.

In an in vitro placenta perfusion model, unbound rivaroxaban was rapidly transferred across the human placenta. Animal Data Rivaroxaban crosses the placenta in animals. Rivaroxaban increased fetal toxicity (increased resorptions, decreased number of live fetuses, and decreased fetal body weight) when pregnant rabbits were given oral doses of ≥10 mg/kg rivaroxaban during the period of organogenesis.

This dose corresponds to about 4 times the human exposure of unbound drug, based on AUC comparisons at the highest recommended human dose of 20 mg/day. Fetal body weights decreased when pregnant rats were given oral doses of 120 mg/kg during the period of organogenesis. This dose corresponds to about 14 times the human exposure of unbound drug.

In rats, peripartal maternal bleeding and maternal and fetal death occurred at the rivaroxaban dose of 40 mg/kg (about 6 times maximum human exposure of the unbound drug at the human dose of 20 mg/day).

8.2Lactation Risk Summary Rivaroxaban has been detected in human milk. There are insufficient data to determine the effects of rivaroxaban on the breastfed child or on milk production. Rivaroxaban and/or its metabolites were present in the milk of rats.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for rivaroxaban and any potential adverse effects on the breastfed infant from rivaroxaban or from the underlying maternal condition (see Data ) . Data Animal Data Following a sin…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary The limited available data on rivaroxaban in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use rivaroxaban tablets with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of rivaroxaban cannot be reliably monitored with standard laboratory testing.

Consider the benefits and risks of rivaroxaban for the mother and possible risks to the fetus when prescribing rivaroxaban tabkets to a pregnant woman [see Warnings and Precautions (5.2 , 5.7) ] . Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnancy is a risk factor for venous thromboembolism and that risk is increased in women with inherited or acquired thrombophilias. Pregnant women with thromboembolic disease have an increased risk of maternal complications including pre-eclampsia.

Maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption and early and late pregnancy loss. Fetal/Neonatal Adverse Reactions Based on the pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate. Labor or Delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding and this risk may be increased during labor or delivery [see Warnings and Precautions (5.7) ].

The risk of bleeding should be balanced with the risk of thrombotic events when considering the use of rivaroxaban tablets in this setting. Data Human Data There are no adequate or well-controlled studies of rivaroxaban in pregnant women, and dosing for pregnant women has not been established. Post-marketing experience is currently insufficient to determine a rivaroxaban-associated risk for major birth defects or miscarriage.

In an in vitro placenta perfusion model, unbound rivaroxaban was rapidly transferred across the human placenta. Animal Data Rivaroxaban crosses the placenta in animals. Rivaroxaban increased fetal toxicity (increased resorptions, decreased number of live fetuses, and decreased fetal body weight) when pregnant rabbits were given oral doses of ≥10 mg/kg rivaroxaban during the period of organogenesis.

This dose corresponds to about 4 times the human exposure of unbound drug, based on AUC comparisons at the highest recommended human dose of 20 mg/day. Fetal body weights decreased when pregnant rats were given oral doses of 120 mg/kg during the period of organogenesis. This dose corresponds to about 14 times the human exposure of unbound drug.

In rats, peripartal maternal bleeding and maternal and fetal death occurred at the rivaroxaban dose of 40 mg/kg (about 6 times maximum human exposure of the unbound drug at the human dose of 20 mg/day).

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of rivaroxaban have been established in pediatric patients from birth to less than 18 years for the treatment of VTE and the reduction in risk of recurrent VTE. Use of rivaroxaban tablets is supported in these age groups by evidence from adequate and well-controlled studies of rivaroxaban in adults with additional pharmacokinetic, safety and efficacy data from a multicenter, prospective, open-label, active-controlled randomized study in 500 pediatric patients from birth to less than 18 years of age.

Rivaroxaban tablets were not studied and therefore dosing cannot be reliably determined or recommended in children less than 6 months who were less than 37 weeks of gestation at birth; had less than 10 days of oral feeding, or had a body weight of less than 2.6 kg [see Dosage and Administration (2.2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) and Clinical Studies (14.8) ] . The safety and effectiveness of rivaroxaban have been established for use in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.

Use of rivaroxaban tablets is supported in these age groups by evidence from adequate and well-controlled studies of rivaroxaban in adults with additional data from a multicenter, prospective, open-label, active controlled study in 112 pediatric patients to evaluate the single- and multiple-dose pharmacokinetic properties of rivaroxaban and the safety and efficacy of rivaroxaban when used for thromboprophylaxis for 12 months in children with single ventricle physiology who had the Fontan procedure [see Dosage and Administration (2.2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) and Clinical Studies (14.9) ] .

Clinical studies that evaluated safety, efficacy, pharmacokinetic and pharmacodynamic data support the use of rivaroxaban 10 mg, 15 mg, and 20 mg tablets in pediatric patients. For the rivaroxaban 2.5 mg tablets, there are no safety, efficacy, pharmacokinetic and pharmacodynamic data to support the use in pediatric patients. Therefore, Rivaroxaban 2.5 mg tablets are not recommended for use in pediatric patients.

Although not all adverse reactions identified in the adult population have been observed in clinical trials of children and adolescent patients, the same warnings and precautions for adults should be considered for children and adolescents.

🧓 Geriatric Use 82 words ▾

8.5Geriatric Use Of the total number of adult patients in clinical trials for the approved indications of rivaroxaban (N=64,943 patients), 64 percent were 65 years and over, with 27 percent 75 years and over. In clinical trials the efficacy of rivaroxaban in the elderly (65 years or older) was similar to that seen in patients younger than 65 years. Both thrombotic and bleeding event rates were higher in these older patients [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] .

🆘 Overdosage 105 words ▾

10 OVERDOSAGE Overdose of rivaroxaban tablets may lead to hemorrhage. Discontinue rivaroxaban tablets and initiate appropriate therapy if bleeding complications associated with overdosage occur. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption.

The use of activated charcoal to reduce absorption in case of rivaroxaban tablets overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not dialyzable [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ] . Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.

An agent to reverse the anti-factor Xa activity of rivaroxaban is available.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Rivaroxaban is a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. Rivaroxaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, rivaroxaban decreases thrombin generation.

12.2Pharmacodynamics Rivaroxaban produces dose-dependent inhibition of FXa activity. Clotting tests, such as prothrombin time (PT), activated partial thromboplastin time (aPTT) and HepTest ® , are also prolonged dose-dependently. In children treated with rivaroxaban, the correlation between anti-factor Xa to plasma concentrations is linear with a slope close to 1.

Monitoring for anticoagulation effect of rivaroxaban using anti-FXa activity or a clotting test is not recommended. Specific Populations Renal Impairment The relationship between systemic exposure and pharmacodynamic activity of rivaroxaban was altered in adult subjects with renal impairment relative to healthy control subjects [see Use in Specific Populations (8.6) ] . Table 18: Percentage Increase in Rivaroxaban PK and PD Measures in Adult Subjects with Renal Impairment Relative to Healthy Subjects from Clinical Pharmacology Studies Measure Parameter Creatinine Clearance (mL/min) 50–79 30–49 15–29 ESRD (on dialysis) Separate stand-alone study.

ESRD (post-dialysis) PT = Prothrombin time; FXa = Coagulation factor Xa; AUC = Area under the plasma concentration-time curve; AUEC = Area under the effect-time curve Exposure AUC 44 52 64 47 56 FXa Inhibition AUEC 50 86 100 49 33 PT Prolongation AUEC 33 116 144 112 158 Hepatic Impairment Anti-Factor Xa activity was similar in adult subjects with normal hepatic function and in mild hepatic impairment (Child-Pugh A class). There is no clear understanding of the impact of hepatic impairment beyond this degree on the coagulation cascade and its relationship to efficacy and safety.

12.3Pharmacokinetics Absorption The absolute bioavailability of rivaroxaban is dose-dependent. For the 2.5 mg and 10 mg dose, it is estimated to be 80% to 100% and is not affected by food. Rivaroxaban 2.5 mg and 10 mg tablets can be taken with or without food.

Rivaroxaban tablets 20 mg administered in the fasted state has an absolute bioavailability of approximately 66%. Coadministration of rivaroxaban tablets with food increases the bioavailability of the 20 mg dose (mean AUC and C max increasing by 39% and 76% respectively with food). Rivaroxaban 15 mg and 20 mg tablets should be taken with food [see Dosage and Administration (2.1) ] .

The maximum concentrations (C max ) of rivaroxaban appear 2 to 4 hours after tablet intake. The pharmacokinetics of rivaroxaban were not affected by drugs altering gastric pH. Coadministration of rivaroxaban tablets (30 mg single dose) with the H 2 -receptor antagonist ranitidine (150 mg twice daily), the antacid aluminum hydroxide/magnesium hydroxide (10 mL) or rivaroxaban tablets (20 mg single dose) with the PPI omeprazole (40 mg once daily) did not show an effect on the bioavailability and exposure of rivaroxaban (see Figure 3 ).

Absorption of rivaroxaban is dependent on the site of drug release in the GI tract. A 29% and 56% decrease in AUC and C max compared to tablet was reported when rivaroxaban granulate is released in the proximal small intestine. Exposure is further reduced when drug is released in the distal small intestine, or ascending colon.

Avoid administration of rivaroxaban distal to the stomach which can result in reduced absorption and related drug exposure. In a study with 44 healthy subjects, both mean AUC and C max values for 20 mg rivaroxaban administered orally as a crushed tablet mixed in applesauce were comparable to that after the whole tablet. However, for the crushed tablet suspended in water and administered via an NG tube followed by a liquid meal, only mean AUC was comparable to t…

🧬 Mechanism of Action 53 words ▾

12.1Mechanism of Action Rivaroxaban is a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. Rivaroxaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, rivaroxaban decreases thrombin generation.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rivaroxaban Tablets, USP are available in the strengths and packages listed below: 2.5 mg tablets are round, white, biconvex and film-coated tablets with “2.5” on one side. The tablets are supplied in the packages listed: NDC 55488-0679-1 Bottle containing 60 tablets NDC 55488-0679-2 Bottle containing 180 tablets NDC 55488-0679-3 Blister package containing 100 tablets (10 blister cards containing 10 tablets each) 10 mg tablets are round, pink, biconvex film-coated tablets with “10” marked on one side.

The tablets are supplied in the packages listed: NDC 55488-0540-1 Bottle containing 30 tablets NDC 55488-0540-2 Bottle containing 90 tablets NDC 55488-0540-3 Bottle containing 1000 tablets 15 mg tablets are round, red, biconvex film-coated tablets with “15” marked on one side. The tablets are supplied in the packages listed: NDC 55488-0541-1 Bottle containing 30 tablets NDC 55488-0541-2 Bottle containing 90 tablets NDC 55488-0541-3 Bottle containing 1000 tablets 20 mg tablets are round, light yellow, biconvex film-coated tablets with “20” marked on one side.

The tablets are supplied in the packages listed: NDC 55488-0542-1 Bottle containing 30 tablets NDC 55488-0542-2 Bottle containing 90 tablets NDC 55488-0542-3 Bottle containing 1000 tablets Store at room temperature between 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]. Keep out of the reach of children.

📦 Storage and Handling 40 words ▾

Store at room temperature between 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]. Keep out of the reach of children.

📋 Description 200 words ▾

11 DESCRIPTION Rivaroxaban USP, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19 H 18 ClN 3 O 5 S and the molecular weight is 435.89. The structural formula is: Rivaroxaban USP is a pure ( S )-enantiomer.

It is an odorless, non-hygroscopic, white or off-white powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablet contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban.

The inactive ingredients of rivaroxaban are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban 2.5 mg tablets is Opadry ® White, containing hypromellose, polyethylene glycol 4000, and titanium dioxide, and for rivaroxaban 10 mg tablets is Opadry ® Pink and for rivaroxaban 15 mg tablets is Opadry ® Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for rivaroxaban 20 mg tablets is Opadry ® Light Yellow, containing ferric oxide yellow, hypromellose, polyethylene glycol 3350, and titanium dioxide.

Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION For the tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Instructions for Patient Use Advise patients to take rivaroxaban tablets only as directed. Remind patients to not discontinue rivaroxaban tablets without first talking to their healthcare professional.

Adults Advise patients with atrial fibrillation to take rivaroxaban tablets once daily with the evening meal. Advise patients for initial treatment of DVT and/or PE to take rivaroxaban 15 mg or 20 mg tablets with food at approximately the same time every day [see Dosage and Administration (2.1) ] . Advise patients who are at a continued risk of recurrent DVT and/or PE after at least 6 months of initial treatment, to take rivaroxaban tablets 10 mg once daily with or without food [see Dosage and Administration (2.1) ].

Advise patients who cannot swallow the tablet whole to crush rivaroxaban tablets and combine with a small amount of applesauce followed by food [see Dosage and Administration (2.6) ] . For patients requiring an NG tube or gastric feeding tube, instruct the patient or caregiver to crush the rivaroxaban tablet and mix it with a small amount of water before administering via the tube [see Dosage and Administration (2.6) ] . If a dose is missed, advise the patient according to the instructions in the Full Prescribing Information based on their dosing schedule [see Dosage and Administration (2.5) ] .

Pediatric Patients The adult caregiver should administer the dose. Advise the caregiver whether the dose needs to be taken with food or not [see Dosage and Administration (2.2) ] . Advise the caregiver the tablet must not be split in an attempt to provide a fraction of a tablet dose [see Dosage and Administration (2.2) ] .

If a child vomits or spits up the dose within 30 minutes after receiving the dose, a new dose should be given. However, if the child vomits more than 30 minutes after the dose is taken, the dose should not be re-administered and the next dose should be taken as scheduled. If a child vomits or spits up the dose repeatedly, the caregiver should contact the child's doctor right away [see Dosage and Administration (2.2) ] .

For children who are unable to swallow whole tablets, rivaroxaban oral suspension may be used. If a dose is missed, advise the patient according to the instructions in the Full Prescribing Information based on their dosing schedule [see Dosage and Administration (2.5) ] . Bleeding Risks Advise patients to report any unusual bleeding or bruising to their physician.

Inform patients that it might take them longer than usual to stop bleeding, and that they may bruise and/or bleed more easily when they are treated with rivaroxaban [see Warnings and Precautions (5.2) ] . If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs or platelet inhibitors, advise patients to watch for signs and symptoms of spinal or epidural hematoma, such as back pain, tingling, numbness (especially in the lower limbs), muscle weakness, and stool or urine incontinence.

If any of these symptoms occur, advise the patient to contact his or her physician immediately [see Boxed Warning ] . Invasive or Surgical Procedures Instruct patients to inform their healthcare professional that they are taking rivaroxaban tablets before any invasive procedure (including dental procedures) is scheduled. Concomitant Medication and Herbals Advise patients to inform their physicians and dentists if they are taking, or plan to take, any prescription or over-the-counter drugs or herbals, so their healthcare professionals can evaluate potential interactions [see Drug Interactions (7) ] .

Pregnancy and Pregnancy-Related Hemorrhage Advise patients to inform their physician immediately if they become pregnant or intend to become pregnant during treatment with rivaroxaban [see Use in Specific Populations (8.1) ] . Advise pregnant women rec…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Rivaroxaban (riv a rox a ban) tablets This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 11/2025 What is the most important information I should know about rivaroxaban tablets? Rivaroxaban tablets may cause serious side effects, including: Increased risk of blood clots if you stop taking rivaroxaban tablets.

People with atrial fibrillation (a type of irregular heart beat) that is not caused by a heart valve problem (non-valvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. Rivaroxaban tablets lower your chance of having a stroke by helping to prevent clots from forming. If you stop taking rivaroxaban tablets, you may have increased risk of forming a clot in your blood.

Do not stop taking rivaroxaban tablets without talking to the doctor who prescribes it for you. Stopping rivaroxaban tablets increases your risk of having a stroke. If you have to stop taking rivaroxaban tablets, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.

Increased risk of bleeding. Rivaroxaban tablets can cause bleeding which can be serious and may lead to death. This is because rivaroxaban tablets are a blood thinner medicine (anticoagulant) that lowers blood clotting.

During treatment with rivaroxaban tablets you are likely to bruise more easily, and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take rivaroxaban tablets and have certain other medical problems. You may have a higher risk of bleeding if you take rivaroxaban tablets and take other medicines that increase your risk of bleeding, including: aspirin or aspirin containing products long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs) warfarin sodium (Coumadin ® , Jantoven ® ) any medicine that contains heparin clopidogrel (Plavix ® ) selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) other medicines to prevent or treat blood clots Tell your doctor if you take any of these medicines.

Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Call your doctor or get medical help right away if you or your child develop any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time, such as: nose bleeds that happen often unusual bleeding from the gums menstrual bleeding that is heavier than normal or vaginal bleeding bleeding that is severe or you cannot control red, pink or brown urine bright red or black stools (looks like tar) cough up blood or blood clots vomit blood or your vomit looks like "coffee grounds" headaches, feeling dizzy or weak pain, swelling, or new drainage at wound sites left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder or diffuse abdominal discomfort (these may be symptoms of rupture of the spleen) Spinal or epidural blood clots (hematoma).

People who take a blood thinner medicine (anticoagulant) like rivaroxaban tablets, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if: a thin tube called an epidural catheter is placed in your back to give you certain medicine you take NSAIDs or a medicine to prevent blood from clotting you have a history of difficult or repeated epidural or spinal punctures you have a history of problems with your spine or have had surgery on your spine If you take rivaroxaban tablets and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots.

Tell your doctor right away if you have: back pain tingling numbness muscle weakness (especial…

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