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Irbesartan 300 mg Tablet, 100-count — NDC 65862-0639-78 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Irbesartan 300 mg Tablet, 100-count — NDC 65862-639-78 (Billing 65862-0639-78)

by Aurobindo Pharma Limited · 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK

This is a package of 100 tablets of Irbesartan 300 mg Tablet from Aurobindo Pharma Limited, marketed since Sep 2012 and currently FDA-listed.

NDC 65862-0639-78
🏷️ FDA NDC (as labeled) 65862-639-78 billing pads the product segment with a zero
This package
Contains100-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.2325/unit — full pricing hub ↓
Product page 65862-0639-05 Also comes in: 30 tablets 65862-639-30 90 tablets 65862-639-90 500 tablets 65862-639-05 2500 tablets 65862-639-26
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65862-639-78
Product NDC 65862-639
11-digit billing NDC 65862063978
SPL Set ID 2113a901-2612-4557-b86d-3afc006fb8bb
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-09-27
Dosage form TABLET
Substance IRBESARTAN

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

GPI-14 36150030000340
GPI class Irbesartan
GCN Seq No 034469
GCN 04750
HICL code 015576
Ingredient (HICL) Irbesartan
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4F
Therapeutic class — specific (HIC3) Antihypertensives, Angiotensin Receptor Antagonist
AHFS code 24:32.08.00
AHFS class Angiotensin Ii Receptor Antagonists
FDB label name IRBESARTAN 300 MG TABLET
FDB brand name Irbesartan
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 034469
  • GCN: 04750
  • GPI-14 (Medi-Span): 36150030000340
  • HICL (First Databank): 015576
  • AHFS class code: 24:32.08.00
Why two NDCs? The FDA registers this code as 65862-639-78 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65862-0639-78. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name IRBESARTAN 300 MG TABLET Ingredient Irbesartan
📖 What it is MedlinePlus · NLM

Irbesartan is used alone or in combination with other medications to treat high blood pressure. It is also used to treat kidney disease caused by diabetes in patients with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) and high blood pressure. Irbesartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. High b...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Irbesartan lowers high blood pressure, which helps reduce your risk of stroke and heart attack. It is also used to slow kidney damage in people with type 2 diabetes, high blood pre...
  • Take it by mouth once a day, with or without food. Following your prescriber's directions and the pharmacy label is important. Try to take it at the same time each day.
  • Some people feel tired, get diarrhea or heartburn, or feel dizzy, especially when standing up quickly. Call your doctor if dizziness is severe or you faint. Get emergency help for...
  • No. Irbesartan can seriously harm or even kill a developing baby, especially in the second and third trimesters. If you become pregnant or think you might be, call your doctor righ...
📖 Read our full Irbesartan guide →
1
Nutrient depletion considerations

Irbesartan may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Irbesartan nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2325 $23.25 / 100 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65862-0639-05 65862-639-05 Main listing 500 TABLET in 1 BOTTLE 2012-09-27 — Active
65862-0639-30 65862-639-30 30 TABLET in 1 BOTTLE 2012-09-27 — Active
65862-0639-78 You're viewing this 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK 2014-09-22 — Active
65862-0639-90 65862-639-90 90 TABLET in 1 BOTTLE 2012-09-27 — Active
65862-0639-26 65862-639-26 2500 TABLET in 1 BAG — — Active

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 10 blister pack in 1 carton / 10 tablet in 1 blister pack.
How does this package differ from NDC 65862-0639-30?
Both are Irbesartan 300 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 65862-0639-30 is the 30 tablets package.
What NDC number is used to bill for this package of Irbesartan 300 mg Tablet?
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
Irbesartan 300 mg 50268-0442-15 AvPAK 50 tablets $0.156 AB Discontinued —
Irbesartan 300 mg 31722-0731-05 Camber 500 tablets $0.162 AB Availability likely —
Irbesartan 300 mg 33342-0049-07 Macleods 30 tablets $0.162 AB Availability likely —
Irbesartan 300 mg 43547-0376-03 Solco 30 tablets $0.162 AB Availability likely —
Irbesartan 300 mg 62332-0043-30 Alembic 30 tablets $0.162 AB Availability likely —
Irbesartan 300 mg 72603-0672-01 NorthStar 30 tablets $0.162 AB Availability likely —
Avapro 300 mg 00024-5852-30 Sanofi-Aventis 30 tablets $8.792 AB Availability likely —
Irbesartan 300 mg 29300-0214-05 Unichem 500 tablets — AB FDA listed —
Irbesartan 300 mg 31722-0162-05 Camber 500 tablets — AB FDA listed —
Irbesartan 300 mg 42291-0942-90 AvKARE 90 tablets — AB FDA listed —
Irbesartan 300 mg 42658-0123-01 Hisun 30 tablets — AB FDA listed —
Irbesartan 300 mg 46708-0441-30 Alembic 30 tablets — AB FDA listed —
Irbesartan 300 mg 50090-2017-00 A-S 30 tablets — AB FDA listed —
Irbesartan 300 mg 50090-2978-00 A-S 30 tablets — AB FDA listed —
Irbesartan 300 mg 50090-6938-00 A-S 90 tablets — AB FDA listed —
Irbesartan 300 mg 50090-7622-00 A-S 90 tablets — AB FDA listed —
Irbesartan 300 mg 50228-0162-05 ScieGen 500 tablets — AB FDA listed —
Irbesartan 300 mg 59746-0449-05 Jubilant 500 tablets — AB FDA listed —
Irbesartan 300 mg 62135-0978-30 Chartwell 30 tablets — AB FDA listed —
Irbesartan 300 mg 63629-5241-01 Bryant 30 tablets — AB FDA listed —
Irbesartan 300 mg 65162-0286-03 Amneal 30 tablets — AB FDA listed —
Irbesartan 300 mgthis 65862-0639-78 Aurobindo 100 tablets — — FDA listed —
Irbesartan 300 mg 70518-1543-01 REMEDYREPACK 90 tablets — AB FDA listed —
Irbesartan 300 mg 70518-2246-00 REMEDYREPACK 90 tablets — AB FDA listed —
Irbesartan 300 mg 71335-0071-01 Bryant 30 tablets — AB FDA listed —
Irbesartan 300 mg 71335-1826-01 Bryant 30 tablets — AB FDA listed —
Irbesartan 300 mg 72189-0270-90 direct 90 tablets — AB FDA listed —
Irbesartan 300 mg 72205-0329-05 Novadoz 500 tablets — AB FDA listed —
Irbesartan 300 mg 68180-0412-02 Lupin 500 tablets — — FDA listed —
Irbesartan 300 mg 53360-1307-00 Sanofi 46153 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2012
On the market since
Sep 2012
📍
2026
Currently FDA-listed
14 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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
ShapeOval
ImprintT33
Size17 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 O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • 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

LabelerAurobindo Pharma Limited
Labeler code65862
First marketedSep 2012
Product typeDrug For Further Processing
Portfolio1,456 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full FDA label FDA SPL

The complete FDA label for this product, 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.
🚨 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 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 102 words ▾

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue irbesartan as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.

When pregnancy is detected, discontinue irbesartan as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 , 8.1 )

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Irbesartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ( 1.2 )

1.1Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Irbesartan tablets may be used alone or in combination with other antihypertensive agents.

1.2Nephropathy in Type 2 Diabetic Patients Irbesartan tablets are indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300 mg/day). In this population, irbesartan tablets reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.2) ] .

⏱️ Dosage and Administration 145 words ▾

2 DOSAGE AND ADMINISTRATION Indication Dose Hypertension ( 2.2 ) 150 mg to 300 mg once daily Diabetic Nephropathy ( 2.3 ) 300 mg once daily

2.1General Considerations Irbesartan tablets may be administered with other antihypertensive agents and with or without food.

2.2Hypertension The recommended initial dose of irbesartan tablets is 150 mg once daily. The dosage can be increased to a maximum dose of 300 mg once daily as needed to control blood pressure [see Clinical Studies (14.1) ].

2.3Nephropathy in Type 2 Diabetic Patients The recommended dose is 300 mg once daily [see Clinical Studies (14.2) ] .

2.4Dose Adjustment in Volume and Salt-Depleted Patients The recommended initial dose is 75 mg once daily in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) [see Warnings and Precautions (5.2) ] .

💊 Dosage Forms and Strengths 90 words ▾

3 DOSAGE FORMS AND STRENGTHS Irbesartan Tablets USP, 75 mg are white to off-white, biconvex, oval shaped uncoated tablets debossed with ‘T31’ on one side and plain on other side. Irbesartan Tablets USP, 150 mg are white to off-white, biconvex, oval shaped uncoated tablets debossed with ‘T32’ on one side and plain on other side. Irbesartan Tablets USP, 300 mg are white to off-white, biconvex, oval shaped uncoated tablets debossed with ‘T33’ on one side and plain on other side.

Tablets: 75 mg, 150 mg, 300 mg ( 3 )

⛔ Contraindications 48 words ▾

4 CONTRAINDICATIONS Irbesartan tablets are contraindicated in patients who are hypersensitive to any component of this product. Do not coadminister aliskiren with irbesartan tablets in patients with diabetes. Hypersensitivity to any component of this product. ( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume or salt depletion prior to administration. ( 5.2 ) Monitor renal function and serum potassium. ( 5.3 )

5.1Fetal Toxicity Irbesartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue irbesartan as soon as possible [see Use in Specific Populations (8.1) ].

5.2Hypotension in Volume or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with irbesartan. Correct volume or salt depletion prior to administration of irbesartan or use a lower starting dose [see Dosage and Administration (2.4) ].

5.3Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe heart failure, or volume depletion) may be at particular risk of developing acute renal failure or death on irbesartan. Monitor renal function periodically in these patients.

Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on irbesartan [see Drug Interactions (7.3) ].

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in the labeling: Hypotension in Volume or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] Impaired Renal Function [see Warnings and Precautions (5.3) ] Nephropathy in type 2 diabetic patients: The most common adverse reactions which were more frequent than placebo were hyperkalemia, dizziness, orthostatic dizziness, and orthostatic hypotension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension Irbesartan has been evaluated for safety in more than 4300 patients with hypertension and about 5000 subjects overall.

This experience includes 1303 patients treated for over 6 months and 407 patients for 1 year or more. In placebo-controlled clinical trials, the following adverse reactions were reported in at least 1% of patients treated with irbesartan (n=1965) and at a higher incidence versus placebo (n=641), excluding those too general to be informative and those not reasonably associated with the use of drug because they were associated with the condition being treated or are very common in the treated population, include: diarrhea (3% vs 2%), dyspepsia/heartburn (2% vs 1%), and fatigue (4% vs 3%).

Irbesartan use was not associated with an increased incidence of dry cough, as is typically associated with ACE inhibitor use. In placebo-controlled studies, the incidence of cough in irbesartan-treated patients was 2.8% versus 2.7% in patients receiving placebo. Nephropathy in Type 2 Diabetic Patients Hyperkalemia: In the Irbesartan Diabetic Nephropathy Trial (IDNT) (proteinuria ≥900 mg/day, and serum creatinine ranging from 1.0 to 3.0 mg/dL), the percent of patients with potassium >6 mEq/L was 18.6% in the irbesartan group versus 6.0% in the placebo group.

Discontinuations due to hyperkalemia in the irbesartan group were 2.1% versus 0.4% in the placebo group. In IDNT, the adverse reactions were similar to those seen in patients with hypertension with the exception of an increased incidence of orthostatic symptoms which occurred more frequently in the irbesartan versus placebo group: dizziness (10.2% vs 6.0%), orthostatic dizziness (5.4% vs 2.7%) and orthostatic hypotension (5.4% vs 3.2%).

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of irbesartan. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure. Blood and lymphatic system : Anemia, Thrombocytopenia Ear and labyrinth : Tinnitus Gastrointestinal: Intestinal angioedema Hepatobiliary : Hepatitis, Jaundice Immune system : Anaphylactic reaction including anaphylactic shock Investigations : Increased liver function tests, Increased CPK (Creatine Phosphokinase) Metabolism and nutrition : Hyperkalemia, Hypoglycemia in diabetic patients Skin and subcutaneous tissue : Urticaria, Angioedema (involving swelling of the face, lips, pharynx, and/or tongue)

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Lithium: Risk of lithium toxicity. ( 7 ) Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and COX-2 inhibitors: Increased risk of renal impairment. Reduced antihypertensive effects. ( 7 ) Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. ( 7 )

7.1Agents Increasing Serum Potassium Coadministration of irbesartan with other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe. Monitor serum potassium in such patients.

7.2Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan and lithium. Monitor lithium levels in patients receiving irbesartan and lithium.

7.3Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including irbesartan) may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving irbesartan and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including irbesartan, may be attenuated by NSAIDs including selective COX-2 inhibitors.

7.4Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.

Closely monitor blood pressure, renal function and electrolytes in patients on irbesartan and other agents that affect the RAS. Do not coadminister aliskiren with irbesartan in patients with diabetes. Avoid use of aliskiren with irbesartan in patients with renal impairment (GFR <60 mL/min).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Potential for adverse effects in infants. ( 8.2 )

8.1Pregnancy Risk Summary Irbesartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [see Clinical Considerations]. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.

When pregnancy is detected, discontinue irbesartan as soon as possible. All pregnancies have a background risk of birth defect, loss or other adverse outcomes regardless of drug exposure. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo-fetal risk Hypertension in pregnancy increases the maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and postpartum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.

Fetal/neonatal adverse reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus.

Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.

If oligohydramnios is observed, consider alternative treatment. Closely observe infants with histories of in utero exposure to irbesartan for hypotension, oliguria, and hyperkalemia and other symptoms of renal impairment. In neonates with a history of in utero exposure to irbesartan, if oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion.

Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function. Data Animal data Irbesartan crosses the placenta in rats and rabbits. In female rats given irbesartan prior to mating through gestation and lactation at oral doses of 50, 180, or 650 mg/kg/day (1.6 to 21.1 times the maximum recommended human dose (MRHD) based on body surface area), fetuses examined on Gestation Day 20 showed increased incidences of hydroureter and renal pelvic cavitation and/or absence of renal papilla in all irbesartan-treated groups.

Subcutaneous edema also occurred in fetuses at maternal doses ≥180 mg/kg/day (5.8 times the MRHD). These anomalies occurred when female rats received irbesartan from prior to mating through Day 20 of gestation but were not observed in pups postnatally in the same study, or when irbesartan was given to pregnant rats only during organogenesis (Gestation Day 6 through Gestation Day 15) at oral doses from 50 to 450 mg/kg/day (up to 14.6 times the MRHD). In addition, no adverse effects on kidney development were observed in pups from dams given irbesartan from Gestation Day 15 through Lactation Day 24 at doses of 50, 180, or 650 mg/kg/day (up to 21.1 times the MRHD).

The observed effects are beli… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Irbesartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [see Clinical Considerations]. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.

When pregnancy is detected, discontinue irbesartan as soon as possible. All pregnancies have a background risk of birth defect, loss or other adverse outcomes regardless of drug exposure. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo-fetal risk Hypertension in pregnancy increases the maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and postpartum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.

Fetal/neonatal adverse reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus.

Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.

If oligohydramnios is observed, consider alternative treatment. Closely observe infants with histories of in utero exposure to irbesartan for hypotension, oliguria, and hyperkalemia and other symptoms of renal impairment. In neonates with a history of in utero exposure to irbesartan, if oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion.

Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function. Data Animal data Irbesartan crosses the placenta in rats and rabbits. In female rats given irbesartan prior to mating through gestation and lactation at oral doses of 50, 180, or 650 mg/kg/day (1.6 to 21.1 times the maximum recommended human dose (MRHD) based on body surface area), fetuses examined on Gestation Day 20 showed increased incidences of hydroureter and renal pelvic cavitation and/or absence of renal papilla in all irbesartan-treated groups.

Subcutaneous edema also occurred in fetuses at maternal doses ≥180 mg/kg/day (5.8 times the MRHD). These anomalies occurred when female rats received irbesartan from prior to mating through Day 20 of gestation but were not observed in pups postnatally in the same study, or when irbesartan was given to pregnant rats only during organogenesis (Gestation Day 6 through Gestation Day 15) at oral doses from 50 to 450 mg/kg/day (up to 14.6 times the MRHD). In addition, no adverse effects on kidney development were observed in pups from dams given irbesartan from Gestation Day 15 through Lactation Day 24 at doses of 50, 180, or 650 mg/kg/day (up to 21.1 times the MRHD).

The observed effects are believed to be late gestational effects of the drug. Pregnant rabbits given oral doses of irbes… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 46 words ▾

8.4Pediatric Use Irbesartan, in a study at a dose of up to 4.5 mg/kg/day, once daily, did not appear to lower blood pressure effectively in pediatric patients ages 6 to 16 years. Irbesartan has not been studied in pediatric patients less than 6 years old.

🧓 Geriatric Use 64 words ▾

8.5Geriatric Use Of 4925 subjects receiving irbesartan in controlled clinical studies of hypertension, 911 (18.5%) were 65 years and over, while 150 (3.0%) were 75 years and over. No overall differences in effectiveness or safety were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. [See Clinical Pharmacology (12.3) and Clinical Studies (14.1) .]

🆘 Overdosage 82 words ▾

10 OVERDOSAGE No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well-tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.

Irbesartan is not removed by hemodialysis. Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25-fold and 50-fold the MRHD (300 mg) based on body surface area, respectively.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.

Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT 1 angiotensin II receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland). There is also an AT 2 receptor in many tissues, but it is not involved in cardiovascular homeostasis. Irbesartan is a specific competitive antagonist of AT 1 receptors with a much greater affinity (more than 8500-fold) for the AT 1 receptor than for the AT 2 receptor and no agonist activity.

Blockade of the AT 1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure. Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis.

12.2Pharmacodynamics In healthy subjects, single oral irbesartan doses of up to 300 mg produced dose-dependent inhibition of the pressor effect of angiotensin II infusions. Inhibition was complete (100%) 4 hours following oral doses of 150 mg or 300 mg and partial inhibition was sustained for 24 hours (60% and 40% at 300 mg and 150 mg, respectively). In hypertensive patients, angiotensin II receptor inhibition following chronic administration of irbesartan causes a 1.5-fold to 2-fold rise in angiotensin II plasma concentration and a 2-fold to 3-fold increase in plasma renin levels.

Aldosterone plasma concentrations generally decline following irbesartan administration, but serum potassium levels are not significantly affected at recommended doses. In hypertensive patients, chronic oral doses of irbesartan (up to 300 mg) had no effect on glomerular filtration rate, renal plasma flow, or filtration fraction. In multiple dose studies in hypertensive patients, there were no clinically important effects on fasting triglycerides, total cholesterol or HDL-cholesterol concentrations.

There was no effect on serum uric acid during chronic oral administration, and no uricosuric effect.

12.3Pharmacokinetics Absorption The oral absorption of irbesartan is rapid and complete with an average absolute bioavailability of 60% to 80%. Following oral administration of irbesartan, peak plasma concentrations of irbesartan are attained at 1.5 to 2 hours after dosing. Food does not affect the bioavailability of irbesartan.

Irbesartan exhibits linear pharmacokinetics over the therapeutic dose range. Distribution Irbesartan is 90% bound to serum proteins (primarily albumin and α 1 -acid glycoprotein) with negligible binding to cellular components of blood. The average volume of distribution is 53 to 93 liters.

Studies in animals indicate that radiolabeled irbesartan weakly crosses the blood-brain barrier and placenta. Irbesartan is excreted in the milk of lactating rats. Elimination Total plasma and renal clearances are in the range of 157 to 176 mL/min and 3.0 to 3.5 mL/min, respectively.

The terminal elimination half-life of irbesartan averages 11 to 15 hours. Steady-state concentrations are achieved within 3 days. Limited accumulation of irbesartan (<20%) is observed in plasma upon repeated once-daily dosing and is not clinically relevant.

Metabolism Irbesartan is an orally active agent that does not require biotransformation into an active form. Irbesartan is metabolized via glucuronide conjugation and oxidation. Following oral or intravenous administration of 14 C-labeled irbesartan, more than 80% of the circulating plasma r… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 200 words ▾

12.1Mechanism of Action Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.

Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT 1 angiotensin II receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland). There is also an AT 2 receptor in many tissues, but it is not involved in cardiovascular homeostasis. Irbesartan is a specific competitive antagonist of AT 1 receptors with a much greater affinity (more than 8500-fold) for the AT 1 receptor than for the AT 2 receptor and no agonist activity.

Blockade of the AT 1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure. Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis.

📦 How Supplied / Storage and Handling 160 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Irbesartan Tablets USP, 75 mg are white to off-white, biconvex, oval shaped uncoated tablets debossed with ‘T31’ on one side and plain on other side. Bottles of 30 NDC 65862-637-30 Bottles of 90 NDC 65862-637-90 Bottles of 500 NDC 65862-637-05 10 x 10 Unit-dose Tablets NDC 65862-637-78 Irbesartan Tablets USP, 150 mg are white to off-white, biconvex, oval shaped uncoated tablets debossed with ‘T32’ on one side and plain on other side. Bottles of 30 NDC 65862-638-30 Bottles of 90 NDC 65862-638-90 Bottles of 500 NDC 65862-638-05 10 x 10 Unit-dose Tablets NDC 65862-638-78 Irbesartan Tablets USP, 300 mg are white to off-white, biconvex, oval shaped uncoated tablets debossed with ‘T33’ on one side and plain on other side.

Bottles of 30 NDC 65862-639-30 Bottles of 90 NDC 65862-639-90 Bottles of 500 NDC 65862-639-05 10 x 10 Unit-dose Tablets NDC 65862-639-78 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

📋 Description 133 words ▾

11 DESCRIPTION Irbesartan is an angiotensin II receptor (AT 1 subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its molecular formula is C 25 H 28 N 6 O, and the structural formula: Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5.

It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan tablets, USP are available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan USP.

Inactive ingredients include: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, microcrystalline cellulose, polysorbate, sodium starch glycolate, sodium stearyl fumarate, and talc. Structure

💬 Information for Patients 94 words ▾

17 PATIENT COUNSELING INFORMATION Pregnancy Advise female patients of childbearing age about the consequences of exposure to irbesartan tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

Potassium Supplements Advise patients receiving irbesartan tablets not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions (7.1) ]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 11/2025

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption The oral absorption of irbesartan is rapid and complete with an average absolute bioavailability of 60% to 80%. Following oral administration of irbesartan, peak plasma concentrations of irbesartan are attained at 1.5 to 2 hours after dosing. Food does not affect the bioavailability of irbesartan.

Irbesartan exhibits linear pharmacokinetics over the therapeutic dose range. Distribution Irbesartan is 90% bound to serum proteins (primarily albumin and α 1 -acid glycoprotein) with negligible binding to cellular components of blood. The average volume of distribution is 53 to 93 liters.

Studies in animals indicate that radiolabeled irbesartan weakly crosses the blood-brain barrier and placenta. Irbesartan is excreted in the milk of lactating rats. Elimination Total plasma and renal clearances are in the range of 157 to 176 mL/min and 3.0 to 3.5 mL/min, respectively.

The terminal elimination half-life of irbesartan averages 11 to 15 hours. Steady-state concentrations are achieved within 3 days. Limited accumulation of irbesartan (<20%) is observed in plasma upon repeated once-daily dosing and is not clinically relevant.

Metabolism Irbesartan is an orally active agent that does not require biotransformation into an active form. Irbesartan is metabolized via glucuronide conjugation and oxidation. Following oral or intravenous administration of 14 C-labeled irbesartan, more than 80% of the circulating plasma radioactivity is attributable to unchanged irbesartan.

The primary circulating metabolite is the inactive irbesartan glucuronide conjugate (approximately 6%). The remaining oxidative metabolites do not add appreciably to irbesartan’s pharmacologic activity. In vitro studies indicate irbesartan is oxidized primarily by CYP2C9; metabolism by CYP3A4 is negligible.

Excretion Irbesartan and its metabolites are excreted by both biliary and renal routes. Following either oral or intravenous administration of 14 C-labeled irbesartan, about 20% of radioactivity is recovered in the urine and the remainder in the feces, as irbesartan or irbesartan glucuronide. Specific Populations Sex No sex-related differences in pharmacokinetics are observed in healthy elderly (age 65 to 80 years) or in healthy young (age 18 to 40 years) subjects.

In studies of hypertensive patients, there is no sex difference in half-life or accumulation, but somewhat higher plasma concentrations of irbesartan are observed in females (11% to 44%). No sex-related dosage adjustment is necessary. Geriatrics In elderly subjects (age 65 to 80 years), irbesartan elimination half-life is not significantly altered, but AUC and C max values are about 20% to 50% greater than those of young subjects (age 18 to 40 years).

No dosage adjustment is necessary in the elderly. Race/ethnicity In healthy black subjects, irbesartan AUC values are approximately 25% greater than whites; there is no difference in C max values. Renal impairment The pharmacokinetics of irbesartan is not altered in patients with renal impairment or in patients on hemodialysis.

Irbesartan is not removed by hemodialysis. No dosage adjustment is necessary in patients with mild to severe renal impairment unless a patient with renal impairment is also volume depleted [see Warnings and Precautions (5.2) and Dosage and Administration (2.4) ]. Hepatic insufficiency The pharmacokinetics of irbesartan following repeated oral administration are not significantly affected in patients with mild to moderate cirrhosis of the liver.

No dosage adjustment is necessary in patients with hepatic insufficiency. Drug-Drug Interactions In vitro studies show significant inhibition of the formation of oxidized irbesartan metabolites with the known cytochrome CYP2C9 substrates/inhibitors sulphenazole, tolbutamide and nifedipine. However, in clinical studies the consequences of concomitant irbesartan on the pharmacodynamics of warfarin were negligible.

Based on in vitro data, no interaction would be expected w… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 172 words ▾

12.2Pharmacodynamics In healthy subjects, single oral irbesartan doses of up to 300 mg produced dose-dependent inhibition of the pressor effect of angiotensin II infusions. Inhibition was complete (100%) 4 hours following oral doses of 150 mg or 300 mg and partial inhibition was sustained for 24 hours (60% and 40% at 300 mg and 150 mg, respectively). In hypertensive patients, angiotensin II receptor inhibition following chronic administration of irbesartan causes a 1.5-fold to 2-fold rise in angiotensin II plasma concentration and a 2-fold to 3-fold increase in plasma renin levels.

Aldosterone plasma concentrations generally decline following irbesartan administration, but serum potassium levels are not significantly affected at recommended doses. In hypertensive patients, chronic oral doses of irbesartan (up to 300 mg) had no effect on glomerular filtration rate, renal plasma flow, or filtration fraction. In multiple dose studies in hypertensive patients, there were no clinically important effects on fasting triglycerides, total cholesterol or HDL-cholesterol concentrations.

There was no effect on serum uric acid during chronic oral administration, and no uricosuric effect.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Hypertension The antihypertensive effects of irbesartan were examined in 7 placebo-controlled 8- to 12-week trials in patients with baseline diastolic blood pressures of 95 to 110 mmHg. Doses of 1 to 900 mg were included in these trials in order to fully explore the dose-range of irbesartan. These studies allowed comparison of once or twice-daily regimens at 150 mg/day, comparisons of peak and trough effects, and comparisons of response by sex, age, and race.

Two of the seven placebo-controlled trials identified above examined the antihypertensive effects of irbesartan and hydrochlorothiazide in combination. The 7 studies of irbesartan monotherapy included a total of 1915 patients randomized to irbesartan (1 to 900 mg) and 611 patients randomized to placebo. Once-daily doses of 150 mg and 300 mg provided statistically and clinically significant decreases in systolic and diastolic blood pressure with trough (24 hours post-dose) effects after 6 to 12 weeks of treatment compared to placebo, of about 8 to 10/5 to 6 mmHg and 8 to 12/5 to 8 mmHg, respectively.

No further increase in effect was seen at dosages greater than 300 mg. The dose-response relationships for effects on systolic and diastolic pressure are shown in Figures 1 and 2. Once-daily administration of therapeutic doses of irbesartan gave peak effects at around 3 to 6 hours and, in one ambulatory blood pressure monitoring study, again around 14 hours.

This was seen with both once-daily and twice-daily dosing. Trough-to-peak ratios for systolic and diastolic response were generally between 60% and 70%. In a continuous ambulatory blood pressure monitoring study, once-daily dosing with 150 mg gave trough and mean 24-hour responses similar to those observed in patients receiving twice-daily dosing at the same total daily dose.

In controlled trials, the addition of irbesartan to hydrochlorothiazide doses of 6.25 mg, 12.5 mg, or 25 mg produced further dose-related reductions in blood pressure similar to those achieved with the same monotherapy dose of irbesartan. HCTZ also had an approximately additive effect. Analysis of age, sex, and race subgroups of patients showed that men and women, and patients over and under 65 years of age, had generally similar responses.

Irbesartan was effective in reducing blood pressure regardless of race, although the effect was somewhat less in blacks (usually a low-renin population). The effect of irbesartan is apparent after the first dose, and it is close to its full observed effect at 2 weeks. At the end of an 8-week exposure, about 2/3 of the antihypertensive effect was still present one week after the last dose.

Rebound hypertension was not observed. There was essentially no change in average heart rate in irbesartan-treated patients in controlled trials. Figure 1.

Placebo-subtracted reduction in trough SeSBP; integrated analysis Figure 1. Placebo-subtracted reduction in trough SeDBP; integrated analysis

14.2Nephropathy in Type 2 Diabetic Patients The Irbesartan Diabetic Nephropathy Trial (IDNT) was a randomized, placebo- and active-controlled, double-blind, multicenter study conducted worldwide in 1715 patients with type 2 diabetes, hypertension (SeSBP >135 mmHg or SeDBP >85 mmHg), and nephropathy (serum creatinine 1.0 to 3.0 mg/dL in females or 1.2 to 3.0 mg/dL in males and proteinuria ≥900 mg/day). Patients were randomized to receive irbesartan 75 mg, amlodipine 2.5 mg, or matching placebo once-daily. Patients were titrated to a maintenance dose of irbesartan 300 mg, or amlodipine 10 mg, as tolerated.

Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and calcium channel blockers) were added as needed to achieve blood pressure goal (≤135/85 or 10 mmHg reduction in systolic blood pressure if higher than 160 mmHg) for patients in all groups. The study population was 66.5% male, 72.9% below 65 years of age, and 72% White (Asian/Pacific Islander 5.0%, Black 13.3%, His… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of carcinogenicity was observed when irbesartan was administered at dosages of up to 500/1000 mg/kg/day (males/females, respectively) in rats and 1000 mg/kg/day in mice for up to 2 years. For male and female rats, 500 mg/kg/day provided an average systemic exposure to irbesartan (AUC 0-24 hour , bound plus unbound) about 3 and 11 times, respectively, the average systemic exposure in humans receiving the maximum recommended human dose (MRHD) of 300 mg irbesartan/day, whereas 1000 mg/kg/day (administered to females only) provided an average systemic exposure about 21 times that reported for humans at the MRHD.

For male and female mice, 1000 mg/kg/day provided an exposure to irbesartan about 3 and 5 times, respectively, the human exposure at 300 mg/day. Irbesartan was not mutagenic in a battery of in vitro tests (Ames microbial test, rat hepatocyte DNA repair test, V79 mammalian-cell forward gene-mutation assay). Irbesartan was negative in several tests for induction of chromosomal aberrations ( in vitro —human lymphocyte assay; in vivo —mouse micronucleus study).

Irbesartan had no adverse effects on fertility or mating of male or female rats at oral dosages ≤650 mg/kg/day, the highest dose providing a systemic exposure to irbesartan (AUC 0-24 hour , bound plus unbound) about 5 times that found in humans receiving the MRHD of 300 mg/day.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of carcinogenicity was observed when irbesartan was administered at dosages of up to 500/1000 mg/kg/day (males/females, respectively) in rats and 1000 mg/kg/day in mice for up to 2 years. For male and female rats, 500 mg/kg/day provided an average systemic exposure to irbesartan (AUC 0-24 hour , bound plus unbound) about 3 and 11 times, respectively, the average systemic exposure in humans receiving the maximum recommended human dose (MRHD) of 300 mg irbesartan/day, whereas 1000 mg/kg/day (administered to females only) provided an average systemic exposure about 21 times that reported for humans at the MRHD.

For male and female mice, 1000 mg/kg/day provided an exposure to irbesartan about 3 and 5 times, respectively, the human exposure at 300 mg/day. Irbesartan was not mutagenic in a battery of in vitro tests (Ames microbial test, rat hepatocyte DNA repair test, V79 mammalian-cell forward gene-mutation assay). Irbesartan was negative in several tests for induction of chromosomal aberrations ( in vitro —human lymphocyte assay; in vivo —mouse micronucleus study).

Irbesartan had no adverse effects on fertility or mating of male or female rats at oral dosages ≤650 mg/kg/day, the highest dose providing a systemic exposure to irbesartan (AUC 0-24 hour , bound plus unbound) about 5 times that found in humans receiving the MRHD of 300 mg/day.

📄 Package Label / Principal Display Panel 216 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg (90 Tablet Bottle) NDC 65862-637-90 Rx only Irbesartan Tablets, USP 75 mg AUROBINDO 90 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg (90 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -75 mg Blister Carton (10 x 10 Unit-dose) NDC 65862-637-78 Rx only Irbesartan Tablets, USP 75 mg AUROBINDO 100 Tablets (10 x 10 Unit-dose) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -75 mg Blister Carton (10 x 10 Unit-dose)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL- 150 mg (90 Tablet Bottle) NDC 65862-638-90 Rx only Irbesartan Tablets, USP 150 mg AUROBINDO 90 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL- 150 mg (90 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -150 mg Blister Carton (10 x 10 Unit-dose) NDC 65862-638-78 Rx only Irbesartan Tablets, USP 150 mg AUROBINDO 100 Tablets (10 x 10 Unit-dose) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -150 mg Blister Carton (10 x 10 Unit-dose)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 300 mg (90 Tablet Bottle) NDC 65862-639-90 Rx only Irbesartan Tablets, USP 300 mg AUROBINDO 90 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 300 mg (90 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 300 mg Blister Carton (10 x 10 Unit-dose) NDC 65862-639-78 Rx only Irbesartan Tablets, USP 300 mg AUROBINDO 100 Tablets (10 x 10 Unit-dose) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 300 mg Blister Carton (10 x 10 Unit-dose)

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 Irbesartan (matched by generic name) — the program that covers self-administered drugs. 8 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 Irbesartan. CMS lists 2 products for this generic; we show the highest-spend one. 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
$12.61M
Claims incl. refills
647.9K
Beneficiaries
530.1K
Spend / beneficiary
$23.80
Spend / claim
$19.47
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Aurobindo Pharma Limited supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aurobindo Pharma Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 30 tablets (65862-0639-30), 90 tablets (65862-0639-90), 500 tablets (65862-0639-05). 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?
Aurobindo Pharma Limited 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.
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.
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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.