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Irbesartan 150 mg Tablet, 50-count

by AvPAK · 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-441-15) / 1 TABLET in 1 BLISTER PACK (50268-441-11)
NDC 50268-0441-15
🏷️ FDA NDC (as labeled) 50268-441-15 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

🚨
Active recall for this product.
Class II · Jan 21, 2025 — Out of Specification for Dissolution (AvKARE) · FDA recall D-0224-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 50268-441-15
Product NDC 50268-441
11-digit billing NDC 50268044115
NCPDP billing unit EA — each (per item)
RxCUI 200094, 200095, 200096
UNII J0E2756Z7N
Application # ANDA202910
SPL Set ID 61b60f94-35e6-b90b-08ce-fbb2fe011f34
Established class (EPC) Angiotensin 2 Receptor Blocker
Mechanism of action Angiotensin 2 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jun 2026)
Marketing start 2023-08-08
Route ORAL
Dosage form TABLET
Substance IRBESARTAN
GPI-14 36150030000320
GPI class Irbesartan
GCN Seq No 034468
GCN 04749
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 150 MG TABLET
FDB brand name Irbesartan
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 50268-441-15 — 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 → 50268-0441-15. 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 Angiotensin 2 Receptor Blocker class.

Pharmacologic class Angiotensin 2 Receptor Blocker
Drug family (ATC) Angiotensin II receptor blockers (ARBs), plain
How it works Angiotensin 2 Receptor Antagonists
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

LabelerAvPAK
Application holderHETERO LABS LTD UNIT V
FDA applicationANDA202910 (ANDA)
Labeler code50268
First marketedAug 2023
Product typeHuman Prescription Drug
Portfolio346 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

Label name IRBESARTAN 150 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 is used for two main things. First, it lowers high blood pressure, which helps protect you from serious events like stroke and heart attack. Second, if you have type 2 d...
  • Food doesn't affect how well irbesartan works, so you can take it with or without a meal — whatever fits your routine best. The most important thing is to take it around the same t...
  • Does it matter if I take it with food or at a certain time of day?
  • Most people do fine on irbesartan. The most common things you might notice are mild diarrhea, heartburn, fatigue, or occasional dizziness — especially when you stand up quickly. Th...
📖 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.

🧪 Inactive Ingredients / Excipients

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

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

Inactive ingredient FAQ

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

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.111 $5.55 / 50 tablet
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 $11.63 / 50 tablet
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.116 $0.110
▼ Down 4% over the last 9 months.
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
Irbesartan 150 mg 31722-0730-05 Camber 500 tablets $0.111 AB Availability likely —
Irbesartan 150 mg 33342-0048-07 Macleods 30 tablets $0.111 AB Availability likely —
Irbesartan 150 mg 43547-0375-03 Solco 30 tablets $0.111 AB Availability likely —
Irbesartan 150 mgthis 50268-0441-15 AvPAK 50 tablets $0.111 AB Discontinued —
Irbesartan 150 mg 62332-0042-30 Alembic 30 tablets $0.111 AB Availability likely —
Irbesartan 150 mg 72603-0671-01 NorthStar 90 tablets $0.111 AB Availability likely —
Avapro 150 mg 00024-5851-30 Sanofi-Aventis 30 tablets $7.345 AB Availability likely +6521%
Irbesartan 150 mg 29300-0213-05 Unichem 500 tablets — AB FDA listed —
Irbesartan 150 mg 31722-0161-10 Camber 1000 tablets — AB FDA listed —
Irbesartan 150 mg 42291-0941-90 AvKARE 90 tablets — AB FDA listed —
Irbesartan 150 mg 42658-0122-01 Hisun 30 tablets — AB FDA listed —
Irbesartan 150 mg 46708-0440-30 Alembic 30 tablets — AB FDA listed —
Irbesartan 150 mg 50090-1284-00 A-S 30 tablets — AB FDA listed —
Irbesartan 150 mg 50228-0161-10 ScieGen 1000 tablets — AB FDA listed —
Irbesartan 150 mg 59746-0448-05 Jubilant 500 tablets — AB FDA listed —
Irbesartan 150 mg 62135-0977-30 Chartwell 30 tablets — AB FDA listed —
Irbesartan 150 mg 63187-0737-10 Proficient 100 tablets — AB FDA listed —
Irbesartan 150 mg 65162-0285-03 Amneal 30 tablets — AB FDA listed —
Irbesartan 150 mg 65862-0638-05 Aurobindo 500 tablets — AB FDA listed —
Irbesartan 150 mg 68788-8670-09 Preferred 90 tablets — AB FDA listed —
Irbesartan 150 mg 70518-1690-01 REMEDYREPACK 90 tablets — AB FDA listed —
Irbesartan 150 mg 70518-2245-00 REMEDYREPACK 90 tablets — AB FDA listed —
Irbesartan 150 mg 71205-0082-30 Proficient 30 tablets — AB FDA listed —
Irbesartan 150 mg 71205-0452-30 Proficient 30 tablets — AB FDA listed —
Irbesartan 150 mg 71335-1244-01 Bryant 30 tablets — AB FDA listed —
Irbesartan 150 mg 71335-1263-01 Bryant 30 tablets — AB FDA listed —
Irbesartan 150 mg 71335-2168-01 Bryant 30 tablets — AB FDA listed —
Irbesartan 150 mg 72162-2354-03 Bryant 30 tablets — AB FDA listed —
Irbesartan 150 mg 72162-2355-03 Bryant 30 tablets — AB FDA listed —
Irbesartan 150 mg 72189-0205-90 direct 90 tablets — AB FDA listed —
Irbesartan 150 mg 72205-0328-05 Novadoz 500 tablets — AB FDA listed —
Irbesartan 150 mg 83008-0084-30 Quality 30 tablets — AB FDA listed —
Irbesartan 150 mg 68180-0411-02 Lupin 500 tablets — — 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

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

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

Medicare Part D (outpatient prescription) spending for Irbesartan — 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. 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Irbesartan — the ingredient across all brands.

Top reported reactions

Fatigue2,816
Nausea2,812
Diarrhoea2,533
Dizziness2,346
Dyspnoea2,251
Acute Kidney Injury2,216
Headache2,164

Age at onset

Neonate22
Infant8
Child11
Adolescent11
Adult2,714
Elderly5,080

Reporter sex

49,395 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization20,408
Life-threatening3,135
Disabling1,695
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 3,027 1,332
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50268-0441-15 You're viewing this 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-441-15) / 1 TABLET in 1 BLISTER PACK (50268-441-11) 2023-08-08 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 50268-441-15, 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: 50268-0441-15, written without dashes as 50268044115. 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 50268-0441-15, the first segment (50268) is the labeler code FDA assigned to AvPAK; the middle segment (0441) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
AvPAK 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 ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 139 words ▾

WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning . • When pregnancy is detected, discontinue irbesartan tablets as soon as possible. (5.1) • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)

5.3Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the reninangiotensin system. Patients whose renal function may depend in part on the activity of the reninangiotensin 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)].

🎯 Indications and Usage ~2 min read ▾

INDICATIONS & USAGE

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 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 199 words ▾

DOSAGE & ADMINISTRATION

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 Irbesartan Tablets USP, 75 mg are white to off white, capsule shaped, biconvex tablets debossed with '158' on one side and 'H' on the other side. Irbesartan Tablets USP, 150 mg are white to off white, capsule shaped, biconvex tablets debossed with '159' on one side and 'H' on the other side.

Irbesartan Tablets USP, 300 mg are white to off white, capsule shaped, biconvex tablets debossed with '160' on one side and 'H' on the other side.

💊 Dosage Forms and Strengths 82 words ▾

Dosage Forms and Strengths Irbesartan Tablets USP, 75 mg are white to off white, capsule shaped, biconvex tablets debossed with '158' on one side and 'H' on the other side. Irbesartan Tablets USP, 150 mg are white to off white, capsule shaped, biconvex tablets debossed with '159' on one side and 'H' on the other side. Irbesartan Tablets USP, 300 mg are white to off white, capsule shaped, biconvex tablets debossed with '160' on one side and 'H' on the other side.

⛔ Contraindications 35 words ▾

CONTRAINDICATIONS Irbesartan tablet USP is contraindicated in patients who are hypersensitive to any component of this product. Do not co-administer aliskiren with irbesartan tablet USP in patients with diabetes (see PRECAUTIONS , Drug Interactions ).

⚠️ Warnings and Cautions 95 words ▾

5.3Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the reninangiotensin system. Patients whose renal function may depend in part on the activity of the reninangiotensin 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)].

⚠️ Warnings 135 words ▾

WARNINGS

5.1Fetal Toxicity 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 tablets 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)].

🤒 Adverse Reactions ~2 min read ▾

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)]

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 >6.0 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%).

6.2Post-Marketing Experience The following adverse reactions have been identified during post-approval 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. Urticaria; angioedema (involving swelling of the face, lips, pharynx, and/or tongue); anaphylactic reaction including anaphylactic shock; increased liver function tests; jaundice; hepatitis; hyperkalemia; thrombocytopenia; increased CPK; tinitus.

To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~2 min read ▾

Drug Interactions Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan or thiazide diuretics. Monitor lithium levels in patients receiving irbesartan and lithium. In vitro studies show significant inhibition of the formation of oxidized irbesartan metabolites with the known cytochrome CYP 2C9 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 with drugs whose metabolism is dependent upon cytochrome P450 isoenzymes 1A1, 1A2, 2A6, 2B6, 2D6, 2E1, or 3A4. In separate studies of patients receiving maintenance doses of warfarin, hydrochlorothiazide, or digoxin, irbesartan administration for 7 days had no effect on the pharmacodynamics of warfarin (prothrombin time) or pharmacokinetics of digoxin.

The pharmacokinetics of irbesartan were not affected by coadministration of nifedipine or hydrochlorothiazide. Concomitant use of potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.

7.1Agents Increas ing 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.

7.3Non-Steroidal Anti-Inflammatory Drugs (NSAIDs ) Including Selective Cyclooxygenas e-2 Inhibitors (COX-2 Inhibitors ) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration 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-Angiotens in Sys tem (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 co-administer aliskiren with irbesartan in patients with diabetes. Avoid use of aliskiren with irbesartan in patients with renal impairment (GFR <60 mL/min).

7.1Agents Increas ing 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.

7.3Non-Steroidal Anti-Inflammatory Drugs (NSAIDs ) Including Selective Cyclooxygenas e-2 Inhibitors (COX-2 Inhibitors ) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including irbesartan) may result in deterioration of renal function,…

🤰 Pregnancy ~2 min read ▾

Pregnancy Pregnancy Category D 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. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters of pregnancy. 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.

Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the reninangiotensin 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.

If oligohydramnios is observed, discontinue irbesartan, unless it is considered lifesaving for the mother. 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.

Closely observe infants with histories of in utero exposure to irbesartan for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4)]. Irbesartan crosses the placenta in rats and rabbits. In pregnant rats given irbesartan at doses greater than the maximum recommended human dose (MRHD), fetuses showed increased incidences of renal pelvic cavitation, hydroureter and/or absence of renal papilla.

Subcutaneous edema also occurred in fetuses at doses about 4 times the MRHD (based on body surface area). These anomalies occurred when pregnant rats received irbesartan through Day 20 of gestation but not when drug was stopped on gestation Day 15. The observed effects are believed to be late gestational effects of the drug.

Pregnant rabbits given oral doses of irbesartan equivalent to 1.5 times the MRHD experienced a high rate of maternal mortality and abortion. Surviving females had a slight increase in early resorptions and a corresponding decrease in live fetuses [see Nonclinical Toxicology (13.2)]. Radioactivity was present in the rat and rabbit fetus during late gestation and in rat milk following oral doses of radiolabeled irbesartan.

🧒 Pediatric Use 92 words ▾

Pediatric Use In infants with histories of in utero exposure to an angiotensin II receptor antagonist observe for hypotension, oliguria, and hyperkalemia. If oliguria occurs, support blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.

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 68 words ▾

Geriatric Use Of 4925 subjects receiving irbesartan in controlled clinical studies of hypertension, 911 (18.5%) were 65 years and over, while 150 (3%) 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 : Pharmacokinetics , Special Populations , and Clinical Studies . )

🆘 Overdosage 80 words ▾

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- and 50-fold the MRHD (300 mg) on a mg/m basis, respectively.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism 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 principal pressor agent of the renin-angiotensin system (RAS) and also stimulates aldosterone synthesis and secretion by adrenal cortex, cardiac contraction, renal resorption of sodium, activity of the sympathetic nervous system, and smooth muscle cell growth. Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT 1 angiotensin II receptor.

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. Because irbesartan does not inhibit ACE, it does not affect the response to bradykinin; whether this has clinical relevance is not known. Pharmacokinetics 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- to 2-fold rise in angiotensin II plasma concentration and a 2- 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, HDL-cholesterol, or fasting glucose concentrations. There was no effect on serum uric acid during chronic oral administration, and no uricosuric effect.

Special Populations Gender No gender-related differences in pharmacokinetics were 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 was no gender difference in half-life or accumulation, but somewhat higher plasma concentrations of irbesartan were observed in females (11 to 44%). No gender-related dosage adjustment is necessary.

Geriatric In elderly subjects (age 65 to 80 years), irbesartan elimination half-life was not significantly altered, but AUC and C max values were about 20% to 50% greater than those of young subjects (age 18 to 40 years). No dosage adjustment is necessary in the elderly. Race In healthy black subjects, irbesartan AUC values were approximately 25% greater than whites; there were no differences in C max values.

Renal Insufficiency The pharmacokinetics of irbesartan were 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 : Hypotension in Volume- or Salt-Depleted Patients and DOSAGE AND ADMINISTRATION .) Hepatic Insufficiency The pharmacokinetics of irbesartan f…

📦 How Supplied / Storage and Handling 153 words ▾

HOW SUPPLIED Irbesartan Tablets USP, 75 mg are white, capsule shaped, biconvex tablets debossed with ‘158’ on one side and ‘H’ on the other side. They are supplied as follows: NDC 50268-440-15 (10 tablets per card, 5 cards per carton). Irbesartan Tablets USP, 150 mg are white, capsule shaped, biconvex tablets debossed with‘159’ on one side and ‘H’ on the other side.

They are supplied as follows: NDC 50268-441-15 (10 tablets per card, 5 cards per carton). Irbesartan Tablets USP, 300 mg are white, capsule shaped, biconvex tablets debossed with ‘160’ on one side and ‘H’ on the other side. They are supplied as follows: NDC 50268-442-15 (10 tablets per card, 5 cards per carton).

Dispensed in Blister Punch Material. For Institutional Use Only. Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature] Manufactured for: AvKARE Pulaski, TN 38478 Mfg.

Rev. 09/19 AV Rev. 07/23 (P)

📋 Description 119 words ▾

DESCRIPTION Irbesartan USP is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical 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 is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of Irbesartan USP.

Inactive ingredients include: calcium stearate, carboxy methyl cellulose calcium, colloidal silicon dioxide, microcrystalline cellulose and povidone. structure.jpg

💬 Information for Patients 44 words ▾

Information for Patients Pregnancy Female patients of childbearing age should be told about the consequences of exposure to irbesartan 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50268-0431-15 · AvPAK 50268-0442-15 · AvPAK →
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.