Pentoxifylline 400 mg Tablet, Extended Release, 100-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Blood Viscosity Reducer class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Pentoxifylline is used to improve blood flow in patients with circulation problems to reduce aching, cramping, and tiredness in the hands and feet. It works by decreasing the thickness (viscosity) of blood. This change allows your blood to flow more easily, especially in the small blood vessels of the hands and feet. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗- Pentoxifylline helps your blood flow more easily through the narrowed arteries in your legs. It makes your blood less thick and your red blood cells more flexible, so more oxygen c...
- What exactly does pentoxifylline do for my legs?
- You might start to notice some improvement in your walking ability within 2 to 4 weeks, but it's recommended to keep taking it for at least 8 weeks to get the full benefit. Studies...
- How long will it take before I notice it working?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Pentoxifylline — tap one for details:
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💊 What it looks like
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🧪 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.
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UNII 2S42T2808B
A synthetic red dye used as a colorant to give the medicine its red color. It helps make pills or liquids visually distinct and easier to identify.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII T4V6TWG28D
A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
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UNII 0VUT3PMY82
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
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UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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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.
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UNII 7T9FYH5QMK
A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
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UNII VH2XOU12IE
Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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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.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
13 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
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Can inactive ingredients matter?
💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.230 | $23.03 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.3244 | $32.44 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.3020 | $30.20 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pentoxifylline 400 mg 00904-5448-61 | Major | 1 tablet | $0.230 | AB | Availability likely | — |
| Pentoxifylline 400 mgthis 16571-0856-01 | Rising | 100 tablets | $0.230 | AB | Availability likely | — |
| Pentoxifylline 400 mg 60505-0033-06 | Apotex | 100 tablets | $0.230 | AB | Availability likely | — |
| Pentoxifylline 400 mg 70954-0668-10 | ANI | 100 tablets | $0.230 | AB | Availability likely | — |
| Pentoxifylline 400 mg 00615-8511-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Pentoxifylline 400 mg 63629-2910-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Pentoxifylline 400 mg 71335-2586-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 16571-0856-01 You're viewing this | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-01) | $0.2303 / ea | $23.03 | 2026-06-05 | Active |
| 16571-0856-50 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-50) | $0.2303 / ea | $115.15 | 2026-06-05 | Active |
| 16571-0856-90 | 1 BLISTER PACK in 1 CARTON (16571-856-90) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | — | — | 2026-06-05 | Active |
| 16571-0856-05 | 50 BLISTER PACK in 1 CARTON (16571-856-05) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | — | — | 2026-06-05 | Active |
| 16571-0856-11 | 10 BLISTER PACK in 1 CARTON (16571-856-11) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | — | — | 2026-06-05 | Active |
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.2303 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 51% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 16571-0856-01?
What is the difference between NDC 16571-0856-01 and NDC 16571-0856-90?
What NDC number is used to bill for this package of Pentoxifylline 400 mg Tablet, Extended Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS & USAGE Pentoxifylline extended-release tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline extended-release tablets can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals. While the effect of pentoxifylline extended-release tablets may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline extended-release tablets should be discontinued.
In patients with severe renal impairment (creatinine clearance below 30 mL/min) reduce dose to 400 mg once a day. Dosing information cannot be provided for patients with hepatic impairment.
⛔ Contraindications ▾
CONTRAINDICATIONS Pentoxifylline extended-release tablets should not be used in patients with recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to this product or methylxanthines such as caffeine, theophylline, and theobromine.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Clinical trials were conducted using either extended-release pentoxifylline tablets for up to 60 weeks or immediate-release pentoxifylline capsules for up to 24 weeks. Dosage ranges in the tablet studies were 400 mg bid to tid and in the capsule studies, 200 mg to 400 mg tid. The table summarizes the incidence (in percent) of adverse reactions considered drug related, as well as the numbers of patients who received extended-release pentoxifylline tablets, immediate-release pentoxifylline capsules, or the corresponding placebos.
The incidence of adverse reactions was higher in the capsule studies (where dose related increases were seen in digestive and nervous system side effects) than in the tablet studies. Studies with the capsule include domestic experience, whereas studies with the extended-release tablets were conducted outside the U.S. The table indicates that in the tablet studies few patients discontinued because of adverse effects.
INCIDENCE (%) OF SIDE EFFECTS Pentoxifylline extended-release tablets have been marketed in Europe and elsewhere since 1972. In addition to the above symptoms, the following have been reported spontaneously since marketing or occurred in other clinical trials with an incidence of less than 1%; the causal relationship was uncertain: Cardiovascular: dyspnea, edema, hypotension. Digestive: anorexia, cholecystitis, constipation, dry mouth/thirst.
Nervous: anxiety, confusion, depression, seizures, aseptic meningitis. Respiratory: epistaxis, flu-like symptoms, laryngitis, nasal congestion. Skin and Appendages: brittle fingernails, pruritus, rash, urticaria, angioedema.
Special Senses: blurred vision, conjunctivitis, earache, scotoma. Miscellaneous: bad taste, excessive salivation, leukopenia, malaise, sore throat/swollen neck glands, weight change. A few rare events have been reported spontaneously worldwide since marketing in 1972.
Although they occurred under circumstances in which a causal relationship with pentoxifylline could not be established, they are listed to serve as information for physicians: Cardiovascular: angina, arrhythmia, tachycardia; Digestive: hepatitis, jaundice, cholestasis, increased liver enzymes; and Hemic and Lymphatic: decreased serum fibrinogen, pancytopenia, aplastic anemia, leukemia, purpura, thrombocytopenia; Immune system disorders: anaphylactic reaction, anaphylactoid reaction, anaphylactic shock. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. pentoxifyllinetable.jpg
🔄 Drug Interactions ▾
DRUG INTERACTIONS Bleeding has been reported in patients treated with pentoxifylline extended-release tablets with or without concomitant NSAIDs, anticoagulants, or platelet aggregation inhibitors. Increased prothrombin time has been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.
Concomitant administration of pentoxifylline extended-release tablets and theophylline-containing drugs leads to increased theophylline levels and theophylline toxicity in some individuals. Monitor theophylline levels when starting pentoxifylline extended-release tablets or changing dose. Concomitant administration of strong CYP1A2 inhibitors (including e.g., ciprofloxacin or fluvoxamine) may increase the exposure to pentoxifylline (see ADVERSE REACTIONS).
Pentoxifylline extended-release tablets have been used concurrently with antihypertensive drugs, beta blockers, digitalis, diuretics, and antiarrhythmics, without observed problems. Small decreases in blood pressure have been observed in some patients treated with pentoxifylline extended-release tablets; periodic systemic blood pressure monitoring is recommended for patients receiving concomitant antihypertensive therapy. If indicated, dosage of the antihypertensive agents should be reduced.
Postmarketing cases of increased anticoagulant activity have been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed. Concomitant administration with cimetidine is reported to increase the average steady state plasma concentration of pentoxifylline (~25%) and the Metabolite I (~30%).
🤰 Pregnancy ▾
Pregnancy: Teratogenicity studies have been performed in rats and rabbits using oral doses up to 576 mg/kg and 264 mg/kg, respectively. On a weight basis, these doses are 24 and 11 times the maximum recommended human daily dose (MRHD); on a body-surface-area basis, they are 4.2 and 3.5 times the MRHD. No evidence of fetal malformation was observed.
Increased resorption was seen in rats of the 576 mg/kg group. There are no adequate and well controlled studies in pregnant women. Pentoxifylline extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
GERIATRIC USE Clinical studies of pentoxifylline extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting 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.
The active Metabolite V is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
OVERDOSAGE Overdosage with pentoxifylline extended-release tablets has been reported in pediatric patients and adults. Symptoms appear to be dose related. A report from a poison control center on 44 patients taking overdoses of enteric-coated pentoxifylline extended-release tablets noted that symptoms usually occurred 4 to 5 hours after ingestion and lasted about 12 hours.
The highest amount ingested was 80 mg/kg; flushing, hypotension, convulsions, somnolence, loss of consciousness, fever, and agitation occurred. All patients recovered. In addition to symptomatic treatment and gastric lavage, special attention must be given to supporting respiration, maintaining systemic blood pressure, and controlling convulsions.
Activated charcoal has been used to absorb pentoxifylline in patients who have overdosed.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mode of Action: Pentoxifylline and its metabolites improve the flow properties of blood by decreasing its viscosity. In patients with chronic peripheral arterial disease, this increases blood flow to the affected microcirculation and enhances tissue oxygenation. The precise mode of action of pentoxifylline and the sequence of events leading to clinical improvement are still to be defined.
Pentoxifylline administration has been shown to produce dose-related hemorrheologic effects, lowering blood viscosity, and improving erythrocyte flexibility. Leukocyte properties of hemorrheologic importance have been modified in animal and in vitro human studies. Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation.
Tissue oxygen levels have been shown to be significantly increased by therapeutic doses of pentoxifylline in patients with peripheral arterial disease. Pharmacokinetics and Metabolism: After oral administration in aqueous solution pentoxifylline is almost completely absorbed. It undergoes a first-pass effect and the various metabolites appear in plasma very soon after dosing.
Peak plasma levels of the parent compound and its metabolites are reached within 1 hour. The major metabolites are Metabolite I (1-[5-hydroxyhexyl]- 3,7-dimethylxanthine) and Metabolite V (1-[3-carboxypropyl]-3,7-dimethylxanthine), and plasma levels of these metabolites are 5 and 8 times greater, respectively, than pentoxifylline. Following oral administration of aqueous solutions containing 100 mg to 400 mg of pentoxifylline, the pharmacokinetics of the parent compound and Metabolite I are dose-related and not proportional (non-linear), with half-life and area under the blood-level time curve (AUC) increasing with dose.
The elimination kinetics of Metabolite V are not dose-dependent. The apparent plasma half-life of pentoxifylline varies from 0.4 to 0.8 hours and the apparent plasma half-lives of its metabolites vary from 1 to 1.6 hours. There is no evidence of accumulation or enzyme induction (Cytochrome P450) following multiple oral doses.
Excretion is almost totally urinary; the main biotransformation product is Metabolite V. Essentially no parent drug is found in the urine. Despite large variations in plasma levels of parent compound and its metabolites, the urinary recovery of Metabolite V is consistent and shows dose proportionality.
Less than 4% of the administered dose is recovered in feces. Food intake shortly before dosing delays absorption of an immediate-release dosage form but does not affect total absorption. The pentoxifylline AUC was increased and elimination rate decreased in an older population (60 to 68 years, n=6) compared to younger individuals (22 to 30 years, n=6) (see PRECAUTIONS: Geriatric Use).
After administration of the 400 mg extended-release pentoxifylline tablet, plasma levels of the parent compound and its metabolites reach their maximum within 2 to 4 hours and remain constant over an extended period of time. Coadministration of pentoxifylline extended-release tablets with meals resulted in an increase in mean AUC and C max of about 1.1 and 1.3 fold for pentoxifylline, respectively. C max for Metabolite I also increased about 1.2 fold.
The extended-release of pentoxifylline from the tablet eliminates peaks and troughs in plasma levels for improved gastrointestinal tolerance. Patients with Hepatic Impairment: In patients with mild to moderate liver impairment AUC and C max of pentoxifylline increased 6.5 and 7.5 fold, respectively, after a single 400 mg dose of pentoxifylline extended-release tablets. AUC and C max of the active Metabolite I also increased 6.9 and 8.2 fold, respectively, in hepatic impaired subjects.
Pentoxifylline extended-release tablets have not been studied in patients with severe hepatic failure. Patients with Renal Impairment: In patients with mild, moderate, or severe renal impairment the exposure to pentoxifylline and…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Pentoxifylline Extended-Release Tablets, USP are available containing 400 mg of pentoxifylline, USP. The 400 mg tablet is a lavender, film-coated, modified capsule-shaped, biconvex tablet debossed with R856 on one side of the tablet and plain on the other side. It is available as follows: NDC 16571-856-01 bottles of 100 tablets NDC 16571-856-50 bottles of 500 tablets NDC 16571-856-90 blister pack of 1 x 10 tablets NDC 16571-856-11 Blister Carton of 100 (10 x 10) tablets NDC 16571-856-05 Blister Carton of 50 (5 x 10) tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India.
Code No. GUJ/DRUGS/G-1430 Revised: 01/2026 PIR85601-03 143186 Rising logo.jpg
📋 Description ▾
DESCRIPTION Pentoxifylline extended-release tablets, USP for oral administration contain 400 mg of the active drug and the following inactive ingredients: D&C Red No. 30 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No.
6 Aluminum Lake, hydroxyethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, titanium dioxide and triacetin in an extended-release formulation. Pentoxifylline USP is a tri-substituted xanthine derivative designated chemically as 1-(5-oxohexyl)-3,7-dimethylxanthine that, unlike theophylline, is a hemorrheologic agent, i.e., an agent that affects blood viscosity. Pentoxifylline USP is soluble in water and ethanol, and sparingly soluble in toluene.
The CAS Registry Number is 6493-05-6. The chemical structure is: Meets USP Dissolution Test 6. pentoxifyllinestruct.jpg