Home › NDC Lookup › Ingredients › Olmesartan Medoxomil › 72189-0558-90
Olmesartan Medoxomil 20 mg Tablet, 90-count — NDC 72189-0558-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Olmesartan Medoxomil 20 mg Tablet, 90-count — NDC 72189-558-90 (Billing 72189-0558-90)

by Direct_rx · 90 TABLET in 1 BOTTLE

This is a package of 90 tablets of Olmesartan Medoxomil 20 mg Tablet from Direct_rx, marketed since Jun 2024 and currently FDA-listed.

NDC 72189-0558-90
🏷️ FDA NDC (as labeled) 72189-558-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.2000/unit — full pricing hub ↓
Product page 72189-0558-30 Also comes in: 30 tablets 72189-558-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-558-90
Product NDC 72189-558
11-digit billing NDC 72189055890
NCPDP billing unit EA — each (per item)
RxCUI 349401
UNII 6M97XTV3HD
Application # ANDA206720
SPL Set ID 1ba299e7-0651-c23b-e063-6294a90a0245
Established class (EPC) Angiotensin 2 Receptor Blocker
Mechanism of action Angiotensin 2 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-24
Route ORAL
Dosage form TABLET
Substance OLMESARTAN MEDOXOMIL
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 050289
GCN 17285
HICL code 023490
Ingredient (HICL) Olmesartan Medoxomil
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 OLMESARTAN MEDOXOMIL 20 MG TAB
FDB brand name Olmesartan Medoxomil
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 050289
  • GCN: 17285
  • HICL (First Databank): 023490
  • AHFS class code: 24:32.08.00
  • RxCUI (RxNorm): 349401
Why two NDCs? The FDA registers this code as 72189-558-90 — 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 → 72189-0558-90. 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.

Clinical

Label name OLMESARTAN MEDOXOMIL 20 MG TAB Ingredient Olmesartan Medoxomil
📗 Our plain-language guide HelloPharmacist
  • Olmesartan is used to treat high blood pressure (hypertension) in adults and in kids as young as six years old. It works by relaxing your blood vessels so your heart doesn't have t...
  • No — this is one of the most important things to know about olmesartan. It can cause very serious harm to an unborn baby, including kidney failure and even death, especially after...
  • Can I take this if I'm pregnant or trying to get pregnant?
  • Dizziness is the most commonly reported side effect — it happens in about 3 out of 100 people in clinical trials. It's most likely when you first start the medicine, especially if...
📖 Read our full Olmesartan guide →
1
Nutrient depletion considerations

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

🧪 Full Olmesartan Medoxomil 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 $0.2000 $18.00 / 90 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
72189-0558-30 72189-558-30 Main listing 30 TABLET in 1 BOTTLE 2024-06-24 — Active
72189-0558-90 You're viewing this 90 TABLET in 1 BOTTLE 2024-06-24 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet in 1 bottle.
How does this package differ from NDC 72189-0558-30?
Both are Olmesartan Medoxomil 20 mg Tablet — the drug itself is identical. This page's package is the 90-count one, while NDC 72189-0558-30 is the 30 tablets package.
What NDC number is used to bill for this package of Olmesartan Medoxomil 20 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
olmesartan medoxomil 20 mg 16729-0321-10 Accord 30 tablets $0.078 AB Availability likely —
Olmesartan Medoxomil 20 mg 00527-2426-32 Lannett 30 tablets $0.080 AB Availability likely —
Olmesartan Medoxomil 20 mg 31722-0853-30 Camber 30 tablets $0.080 AB Availability likely —
Olmesartan Medoxomil 20 mg 43547-0300-03 Solco 30 tablets $0.080 AB Availability likely —
olmesartan medoxomil 20 mg 50228-0340-10 ScieGen 1000 tablets $0.080 AB Availability likely —
Olmesartan Medoxomil 20 mg 64980-0602-03 Rising 30 tablets $0.080 AB Availability likely —
Olmesartan medoxomil 20 mg 72205-0166-30 Novadoz 30 tablets $0.080 AB Availability likely —
Olmesartan Medoxomil 20 mg 72241-0079-04 Modavar 90 tablets $0.080 AB Availability likely —
Olmesartan Medoxomil 20 mg 72303-0849-01 HEC 30 tablets $0.080 AB Availability likely —
Olmesartan Medoxomil 20 mg 82009-0074-90 QUALLENT 90 tablets $0.080 AB Availability likely —
Olmesartan medoxomil 20 mg 33342-0179-07 Macleods 30 tablets $0.081 AB Availability likely —
Olmesartan Medoxomil 20 mg 70756-0809-30 Lifestar 30 tablets $0.089 AB FDA listed —
Benicar 20 mg 00713-0861-30 Cosette 30 tablets $12.316 AB Availability likely —
Benicar 20 mg 00713-0941-30 Cosette 30 tablets $12.316 AB Availability likely —
Olmesartan Medoxomil 20 mg 42571-0202-05 Micro 500 tablets — AB Discontinued —
Olmesartan Medoxomil 20 mg 46708-0132-10 Alembic 100 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 49252-0066-10 Inventia 30 tablets — AB FDA listed —
olmesartan medoxomil 20 mg 50090-3471-00 A-S 30 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 50090-3656-00 A-S 30 tablets — AB FDA listed —
olmesartan medoxomil 20 mg 50090-6606-00 A-S 90 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 50090-6686-00 A-S 90 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 50090-7872-00 A-S 90 tablets — AB FDA listed —
olmesartan medoxomil 20 mg 51407-0198-30 Golden 30 tablets — AB FDA listed —
olmesartan medoxomil 20 mg 59746-0465-01 Jubilant 100 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 60290-0010-01 Umedica 30 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 62135-0881-30 Chartwell 30 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 62332-0132-10 Alembic 100 tablets — AB FDA listed —
olmesartan medoxomil 20 mg 63629-8522-01 Bryant 90 tablets — AB FDA listed —
olmesartan medoxomil 20 mg 63629-8523-01 Bryant 30 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 65862-0742-01 Aurobindo 100 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 67877-0446-05 Ascend 500 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 68462-0437-10 Glenmark 1000 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 70518-1343-00 REMEDYREPACK 90 tablets — AB FDA listed —
olmesartan medoxomil 20 mg 70518-4316-00 REMEDYREPACK 100 tablets — AB FDA listed —
Olmesartan medoxomil 20 mg 70518-4598-00 REMEDYREPACK 100 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 71205-0172-30 Proficient 30 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 71205-0458-30 Proficient 30 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 71209-0080-01 Cadila 30 tablets — AB FDA listed —
olmesartan medoxomil 20 mg 71335-0775-01 Bryant 30 tablets — AB FDA listed —
olmesartan medoxomil 20 mg 71335-1920-01 Bryant 30 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 71335-2399-01 Bryant 30 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 71335-2448-01 Bryant 30 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 72189-0137-30 direct 30 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mg 72189-0548-90 Direct_Rx 90 tablets — AB FDA listed —
Olmesartan Medoxomil 20 mgthis 72189-0558-90 Direct_rx 90 tablets — AB FDA listed —
Olmesartan medoxomil 20 mg 72603-0951-01 NorthStar 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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.

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.

Manufacturer & labeler

LabelerDirect_rx
Application holderPRINSTON PHARMACEUTICAL INC
FDA applicationANDA206720 (ANDA)
Labeler code72189
First marketedJun 2024
Product typeHuman Prescription Drug
Portfolio352 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 prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🚨 Boxed Warning 38 words ▾

WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue olmesartan medoxomil tablets 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 ▾

Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.

There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. 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 one 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. It may be used alone or in combination with other antihypertensive agents.

⏱️ Dosage and Administration ~2 min read ▾

2.1Adult Hypertension Dosage must be individualized. The usual recommended starting dose of olmesartan medoxomil tablets is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of olmesartan medoxomil tablets may be increased to 40 mg.

Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate olmesartan medoxomil tablets under close medical supervision and give consideration to use of a lower starting dose [see Warnings and Precautions (5.3)].

2.2Pediatric Hypertension (6 Years of Age and Older) Dosage must be individualized. For children who can swallow tablets, the usual recommended starting dose of olmesartan medoxomil tablets is 10 mg once daily for patients who weigh 20 to <35 kg (44 to 77 lb), or 20 mg once daily for patients who weigh ≥35 kg. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of olmesartan medoxomil tablets may be increased to a maximum of 20 mg once daily for patients who weigh <35 kg or 40 mg once daily for patients who weigh ≥35 kg.

Use of olmesartan medoxomil tablets in children <1 year of age is not recommended [see Warnings and Precautions (5.2) and Use in Specific Populations (8.4)]. For children who cannot swallow tablets, the same dose can be given using an extemporaneous suspension as described below [see Clinical Pharmacology (12.3)]. Follow the suspension preparation instructions below to administer olmesartan medoxomil tablets as a suspension.

Preparation of Suspension (for 200 mL of a 2 mg/mL suspension) Add 50 mL of Purified Water to an amber polyethylene terephthalate (PET) bottle containing twenty olmesartan medoxomil 20 mg tablets and allow to stand for a minimum of 5 minutes. Shake the container for at least 1 minute and allow the suspension to stand for at least 1 minute. Repeat 1-minute shaking and 1-minute standing for four additional times.

Add 100 mL of ORA-Sweet® and 50 mL of ORA-Plus®1* to the suspension and shake well for at least 1 minute. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 4 weeks. Shake the suspension well before each use and return promptly to the refrigerator.

1 * ORA-Sweet® and ORA-Plus® are registered trademarks of their respective owners.

💊 Dosage Forms and Strengths 59 words ▾

5 mg pink, round, film-coated, non-scored tablets debossed with S299 on one side and plain on the other side • 20 mg white, round, film-coated, non-scored tablets debossed with S300 on one side and plain on the other side • 40 mg white, capsule-shaped, film-coated, non-scored tablets debossed with S301 on one side and plain on the other side

⛔ Contraindications 16 words ▾

Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes [see Drug Interactions (7.3)].

⚠️ Warnings and Cautions ~2 min read ▾

5.1Fetal Toxicity Olmesartan medoxomil tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system (RAS) 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 olmesartan medoxomil tablets as soon as possible [see Use in Specific Populations (8.1)].

5.2Morbidity in Infants Use of olmesartan medoxomil tablets in children <1 year of age is not recommended. Drugs that act directly on the renin-angiotensin-aldosterone system (RAAS) can have effects on the development of immature kidneys [see Use in Specific Populations (8.4)].

5.3Hypotension in Volume- or Salt-Depleted Patients In patients with an activated renin-angiotensin-aldosterone system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may be anticipated after initiation of treatment with olmesartan medoxomil tablets. Initiate treatment under close medical supervision and consider starting at a lower dose. If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline [see Dosage and Administration (2.1)].

A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

5.4Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil tablets. In patients whose renal function may depend upon the activity of the renin-angiotensinaldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death.

Similar results may be anticipated in patients treated with olmesartan medoxomil tablets [see Dosage and Administration (2.1), Drug Interactions (7.3), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil tablets in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected.

5.5Sprue-like Enteropathy Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider alternative antihypertensive therapy in cases where no other etiology is identified.

5.6Hyperkalemia Serum potassium should be monitored in patients receiving olmesartan medoxomil tablets. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes [see Drug Interactions (7.3)].

🤒 Adverse Reactions ~3 min read ▾

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Olmesartan medoxomil tablets has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. This experience included about 900 patients treated for at least 6 months and more than 525 for at least 1 year.

Events generally were mild, transient and had no relationship to the dose of olmesartan medoxomil tablets. Analysis of gender, age and race groups demonstrated no differences between olmesartan medoxomil tablets and placebo-treated patients. The rate of withdrawals due to adverse reactions in all trials of hypertensive patients was 2.4% (i.e., 79/3278) of patients treated with olmesartan medoxomil tablets and 2.7% (i.e., 32/1179) of control patients.

In placebo-controlled trials, the only adverse reaction that occurred in more than 1% of patients treated with olmesartan medoxomil tablets and at a higher incidence versus placebo was dizziness (3% vs. 1%). Facial edema was reported in five patients receiving olmesartan medoxomil tablets.

Angioedema has been reported with angiotensin II antagonists. Pediatric Hypertension No relevant differences were identified between the adverse experience profile for pediatric patients aged 1 to 16 years and that previously reported for adult patients.

6.2Post-Marketing Experience The following adverse reactions have been reported in post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole: Asthenia, angioedema, anaphylactic reactions Gastrointestinal: Vomiting, sprue-like enteropathy [see Warnings and Precautions (5.5)] Metabolic and Nutritional Disorders: Hyperkalemia Musculoskeletal: Rhabdomyolysis Urogenital System: Acute renal failure, increased blood creatinine levels Skin and Appendages: Alopecia, pruritus, urticaria Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive.

The randomized, placebo-controlled, double-blind ROADMAP trial (Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention trial, n=4447) examined the use of olmesartan, 40 mg daily, vs. placebo in patients with type 2 diabetes mellitus, normoalbuminuria, and at least one additional risk factor for CV disease. The trial met its primary endpoint, delayed onset of microalbuminuria, but olmesartan had no beneficial effect on decline in glomerular filtration rate (GFR). There was a finding of increased CV mortality (adjudicated sudden cardiac death, fatal myocardial infarction, fatal stroke, revascularization death) in the olmesartan group compared to the placebo group (15 olmesartan vs.

3 placebo, HR 4.9, 95% confidence interval [CI], 1.4, 17), but the risk of non-fatal myocardial infarction was lower with olmesartan (HR 0.64, 95% CI 0.35, 1.18). The epidemiologic study included patients 65 years and older with overall exposure of > 300,000 patient-years. In the sub-group of diabetic patients receiving high-dose olmesartan (40 mg/d) for > 6 months, there appeared to be an increased risk of death (HR 2.0, 95% CI 1.1, 3.8) compared to similar patients taking other angiotensin receptor blockers.

In contrast, high-dose olmesartan use in non-diabetic patients appeared to be associated with a decreased risk of death (HR 0.46, 95% CI 0.24, 0.86) compared to similar patients taking other angiotensin receptor blockers. No differences were observed between the groups receiving lower doses of olmesartan com…

🔄 Drug Interactions ~2 min read ▾

7.1Agents Increasing Serum Potassium Concomitant use of olmesartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium. If co-medication is considered necessary, monitoring of serum potassium is advisable.

7.2Non-Steroidal Anti-Inflammatory Agents 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, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including olmesartan medoxomil, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving olmesartan medoxomil and NSAID therapy.

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

7.3Dual 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 olmesartan medoxomil tablets and other agents that affect the RAS. Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes [see Contraindications (4)]. Avoid use of aliskiren with olmesartan medoxomil tablets in patients with renal impairment (GFR <60 ml/min).

7.4Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including olmesartan medoxomil tablets. Monitor serum lithium levels during concomitant use.

7.5Colesevelam Hydrochloride Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose [see Clinical Pharmacology (12.3)].

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Risk Summary Olmesartan medoxomil tablets 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. 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.

In animal reproduction studies, olmesartan medoxomil tablets treatment during organogenesis resulted in increased embryofetal toxicity in rats at doses lower than maternally toxic doses. When pregnancy is detected, discontinue olmesartan medoxomil tablets as soon as possible. Consider alternative antihypertensive therapy during pregnancy.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum 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 patients taking olmesartan medoxomil tablets during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation.

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 olmesartan medoxomil tablets for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to olmesartan medoxomil tablets, if oliguria or hypotension occurs, utilize measures to maintain adequate blood pressure and renal perfusion.

Exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function. Data Animal Data No teratogenic effects were observed when olmesartan medoxomil was administered to pregnant rats at oral doses up to 1000 mg/kg/day (240 times the maximum recommended human dose (MRHD) on a mg/m2 basis) or pregnant rabbits at oral doses up to 1 mg/kg/day (half the MRHD on a mg/m2 basis; higher doses could not be evaluated for effects on fetal development as they were lethal to the does).

In rats, significant decreases in pup birth weight and weight gain were observed at doses ≥1.6 mg/kg/day, and delays in developmental milestones (delayed separation of ear auricula, eruption of lower incisors, appearance of abdominal hair, descent of testes, and separation of eyelids) and dose-dependent increases in the incidence of dilation of the renal pelvis were observed at doses ≥ 8 mg/kg/day. The no observed effect dose for developmental toxicity in rats is 0.3 mg/kg/day, about one-tenth the MRHD of 40 mg/day.

8.2Lactation Risk Summary There is no information regarding the presence of olmesartan in human milk, the effects on the breastfed infant, or the effects on milk production. Olmesartan is secreted at l…

🆘 Overdosage 42 words ▾

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. If symptomatic hypotension occurs, initiate supportive treatment. The dialyzability of olmesartan is unknown.

🧬 Clinical Pharmacology ~3 min read ▾

12.1Mechanism of Action Angiotensin II is 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, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation and renal reabsorption of sodium. Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle.

Its action is, therefore, independent of the pathways for angiotensin II synthesis. An AT2 receptor is found also in many tissues, but this receptor is not known to be associated with cardiovascular homeostasis. Olmesartan has more than a 12,500-fold greater affinity for the AT1 receptor than for the AT2 receptor.

Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is a mechanism of many drugs used to treat hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because olmesartan medoxomil does not inhibit ACE (kininase II), it does not affect the response to bradykinin.

Whether this difference has clinical relevance is not yet known. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II levels do not overcome the effect of olmesartan on blood pressure.

12.2Pharmacodynamics Olmesartan medoxomil tablets doses of 2.5 mg to 40 mg inhibit the pressor effects of angiotensin I infusion. The duration of the inhibitory effect was related to dose, with doses of olmesartan medoxomil tablets >40 mg giving >90% inhibition at 24 hours. Plasma concentrations of angiotensin I and angiotensin II and plasma renin activity (PRA) increase after single and repeated administration of olmesartan medoxomil tablets to healthy subjects and hypertensive patients.

Repeated administration of up to 80 mg olmesartan medoxomil tablets had minimal influence on aldosterone levels and no effect on serum potassium.

12.3Pharmacokinetics Absorption Olmesartan medoxomil is rapidly and completely bioactivated by ester hydrolysis to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil tablets and the suspension formulation prepared from olmesartan medoxomil tablets are bioequivalent [see Dosage and Administration (2.2)]. The absolute bioavailability of olmesartan is approximately 26%.

After oral administration, the peak plasma concentration (Cmax) of olmesartan is reached after 1 to 2 hours. Food does not affect the bioavailability of olmesartan. Olmesartan medoxomil tablets may be administered with or without food.

Distribution The volume of distribution of olmesartan is approximately 17 L. Olmesartan is highly bound to plasma proteins (99%) and does not penetrate red blood cells. The protein binding is constant at plasma olmesartan concentrations well above the range achieved with recommended doses.

In rats, olmesartan crossed the blood-brain barrier poorly, if at all. Olmesartan passed across the placental barrier in rats and was distributed to the fetus. Olmesartan was distributed to milk at low levels in rats.

Metabolism and Excretion Following the rapid and complete conversion of olmesartan medoxomil to olmesartan during absorption, there is virtually no further metabolism of olmesartan. Total plasma clearance of olmesartan is

1.3 L/h, with a renal clearance of

0.6L/h. Approximately 35% to 50% of the absorbed dose is recovered in urine while the remainder is eliminated in feces via the bile. Olmesartan appears to be eliminated in a biphasic manner with a terminal elimination half-life of approximately 13 hours. Olmesartan shows linear pharmacokinetics following single oral doses of up to 320 mg and multiple oral doses of up…

📦 How Supplied / Storage and Handling 107 words ▾

Olmesartan medoxomil tablets, USP, are supplied as pink, round, film-coated, non-scored tablets containing 5 mg of olmesartan medoxomil, as white, round, film-coated, non-scored tablets containing 20 mg of olmesartan medoxomil, and as white, capsule-shaped, film-coated, non-scored tablets containing 40 mg of olmesartan medoxomil. Tablets are plain on one side and debossed with S299, S300, or S301 on the other side of the 5, 20, and 40 mg tablets, respectively. Tablets are supplied as follows: 5 mg 20 mg 40 mg Bottle of 30 NDC 43547-299-03 NDC 43547-300-03 NDC 43547-301-03 Bottle of 90 NDC 43547-299-09 NDC 72189-558-90 NDC 43547-301-09 Bottle of 500 NDC 43547-299-50 NDC 43547-300-50 NDC 43547-301-50

📦 Storage and Handling 10 words ▾

Storage Store at 20-25oC (68-77oF) [see USP Controlled Room Temperature].

📋 Description 156 words ▾

Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.

Its empirical formula is C29H30N6O6 and its structural formula is: [structural formula] Olmesartan medoxomil is a white or off-white crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP, are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil (USP) and the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol/polyethylene glycol 3350, talc, (5 mg only) FD&C Red #40 Aluminum Lake, (5 mg only) FD&C Yellow #6 Aluminum Lake, (5 mg only) FD&C Blue #1 Aluminum Lake.

FDA approved dissolution test specifications differ from USP.

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 Olmesartan Medoxomil — the program that covers self-administered drugs. 14 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 Olmesartan Medoxomil. 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
$18.95M
Claims incl. refills
1M
Beneficiaries
847.8K
Spend / beneficiary
$22.35
Spend / claim
$18.14
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

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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 Direct_rx. 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 1 other package presentation of this same product, including 30 tablets (72189-0558-30). 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?
Direct_rx 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.
← 72189-0557-30 · Direct_rx 72189-0559-20 · Diirect_rx →
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.