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Nadolol 20 mg Tablet, 100-count — NDC 59651-0589-01 package photo

Nadolol 20 mg Tablet, 100-count

by Aurobindo Pharma Limited · 100 TABLET in 1 BOTTLE (59651-589-01)
NDC 59651-0589-01
🏷️ FDA NDC (as labeled) 59651-589-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 59651-589-01
Product NDC 59651-589
11-digit billing NDC 59651058901
NCPDP billing unit EA — each (per item)
RxCUI 198006, 198007, 198008
UNII FEN504330V
Application # ANDA201893
SPL Set ID 44c5352d-89f8-4bd3-9479-1069304562ca
Established class (EPC) beta-Adrenergic Blocker
Mechanism of action Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-06-07
Route ORAL
Dosage form TABLET
Substance NADOLOL
GPI-14 33100010000303
GCN Seq No 005135
GCN 20654
HICL code 002103
Ingredient (HICL) Nadolol
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J7
Therapeutic class — intermediate (HIC2) Antiadrenergics
HIC3 code J7C
Therapeutic class — specific (HIC3) Beta-Adrenergic Blocking Agents
AHFS code 12:16.08.08
AHFS class Selective Beta-Adrenergic Blocking Agent
FDB label name NADOLOL 20 MG TABLET
FDB brand name Nadolol
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 59651-589-01 — 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 → 59651-0589-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker
Drug family (ATC) Beta blocking agents, non-selective
How it works Adrenergic beta-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

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA201893 (ANDA)
Labeler code59651
First marketedJun 2022
Product typeHuman Prescription Drug
Portfolio1,456 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name NADOLOL 20 MG TABLET Ingredient Nadolol
📖 What it is MedlinePlus · NLM

Nadolol is used to treat high blood pressure and angina (chest pain). Nadolol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Nadolol is used to treat two main conditions: high blood pressure and angina pectoris — that's ongoing chest pain caused by the heart not getting enough blood flow. For high blood...
  • Please don't stop nadolol suddenly — this is one of the most important things to know about this medication. Stopping abruptly, especially if you have any heart disease, can trigge...
  • Can I stop taking nadolol if I feel fine or if I run out?
  • The most common things people notice are a slower heart rate, feeling tired or a little dizzy, and sometimes cold hands or feet. Stomach issues like nausea, diarrhea, or bloating a...
📖 Read our full Nadolol guide →
1
Nutrient depletion considerations

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

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.

💊 What it looks like

Color Blue
ShapeRound
ImprintNA;80
Size11 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII X7XJ6RM9Q2
    A plant-derived cellulose processed into tiny crystals. It acts as a binder and filler to give the tablet or capsule structure and helps the medicine break apart properly in your stomach.
  • UNII RDH86HJV5Z
    Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.147 $14.65 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.3844 $38.44 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.4871 $48.71 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.204 $0.147
▼ Down 13% over the last 10 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
Nadolol 20 mgthis 59651-0589-01 Aurobindo 100 tablets $0.147 AB Availability likely —
Nadolol 20 mg 60687-0887-21 American 30 tablets $0.147 AB Availability likely —
Nadolol 20 mg 68001-0630-00 BluePoint 100 tablets $0.147 AB Availability likely —
Nadolol 20 mg 68001-0690-00 BluePoint 100 tablets $0.147 AB Availability likely —
Nadolol 20 mg 68382-0732-01 Zydus 100 tablets $0.147 AB Availability likely —
Nadolol 20 mg 76282-0347-01 Exelan 100 tablets $0.147 AB Availability likely —
Nadolol 20 mg 76385-0133-01 UNICHEM 100 tablets $0.147 AB Availability likely —
Nadolol 20 mg 68001-0317-00 BluePoint 100 tablets $0.195 AB FDA listed +33%
Nadolol 20 mg 60687-0302-25 American 30 tablets $0.195 AB Discontinued +33%
Nadolol 20 mg 72664-0211-01 VGYAAN 100 tablets $0.221 AB FDA listed +51%
Nadolol 20 mg 46708-0402-30 Alembic 30 tablets — AB FDA listed —
Nadolol 20 mg 50090-7995-00 A-S 30 tablets — AB FDA listed —
Nadolol 20 mg 51407-0977-01 Golden 100 tablets — AB FDA listed —
Nadolol 20 mg 62332-0402-30 Alembic 30 tablets — AB FDA listed —
Nadolol 20 mg 69097-0867-02 Cipla 30 tablets — AB FDA listed —
Nadolol 20 mg 69238-1123-01 Amneal 1000 tablets — AB FDA listed —
Nadolol 20 mg 70771-1089-00 Zydus 1000 tablets — AB FDA listed —
Nadolol 20 mg 72162-2234-01 Bryant 100 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

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 59651-0589-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
6.4K
Units reimbursed last 4 qtrs
390.5K
Gross reimbursed last 4 qtrs
$150.1K
Avg / prescription
$23.49
Avg / unit
$0.3844
Latest quarter Q1 2026
2.6KRx
Medicaid pays / ea
$0.3844
gross reimbursed
vs
NADAC / ea
$0.1465
acquisition cost
=
Spread
+$0.2379
+162% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
29% FFS 71% MCO
Fee-for-service · 1,839 Rx Managed care · 4,551 Rx
State Medicaid map
Alaska: 1,530 units · 209 per 100k residents AK Maine: no data reported ME Washington: 4,947 units · 63.3 per 100k residents WA Idaho: 839 units · 42.7 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 2,598 units · 45.3 per 100k residents MN Wisconsin: 4,920 units · 83.2 per 100k residents WI Michigan: 6,438 units · 64.1 per 100k residents MI New York: 26,113 units · 133 per 100k residents NY Vermont: no data reported VT New Hampshire: 2,874 units · 205 per 100k residents NH Oregon: 2,988 units · 70.6 per 100k residents OR Nevada: 1,275 units · 39.9 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,948 units · 60.7 per 100k residents IA Illinois: 13,441 units · 107 per 100k residents IL Indiana: 6,206 units · 90.4 per 100k residents IN Ohio: 29,141 units · 247 per 100k residents OH Pennsylvania: 37,200 units · 287 per 100k residents PA New Jersey: 11,409 units · 123 per 100k residents NJ Massachusetts: 77,411 units · 1,106 per 100k residents MA California: 7,170 units · 18.4 per 100k residents CA Utah: no data reported UT Colorado: 2,087 units · 35.5 per 100k residents CO Nebraska: 1,287 units · 65.1 per 100k residents NE Missouri: 8,864 units · 143 per 100k residents MO Kentucky: 10,414 units · 230 per 100k residents KY West Virginia: 6,013 units · 340 per 100k residents WV Virginia: 14,012 units · 161 per 100k residents VA Maryland: 7,777 units · 126 per 100k residents MD Connecticut: 19,785 units · 547 per 100k residents CT Rhode Island: 8,802 units · 804 per 100k residents RI Arizona: 2,542 units · 34.2 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 6,003 units · 84.2 per 100k residents TN North Carolina: 15,510 units · 143 per 100k residents NC South Carolina: 10,905 units · 203 per 100k residents SC Delaware: 1,188 units · 115 per 100k residents DE Oklahoma: 4,500 units · 111 per 100k residents OK Louisiana: 705 units · 15.4 per 100k residents LA Mississippi: 495 units · 16.8 per 100k residents MS Alabama: 2,659 units · 52.1 per 100k residents AL Georgia: 21,488 units · 195 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 6,971 units · 30.8 per 100k residents FL
Units reimbursed · per 100k residents
15.41,106
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Massachusetts 1,106 /100k
2 Rhode Island 804 /100k
3 Connecticut 547 /100k
4 West Virginia 340 /100k
5 Pennsylvania 287 /100k
6 Ohio 247 /100k
7 Kentucky 230 /100k
8 Alaska 209 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Nadolol — the program that covers self-administered drugs. 9 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 Nadolol. 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
$3.19M
Claims incl. refills
69K
Beneficiaries
44.7K
Spend / beneficiary
$71.23
Spend / claim
$46.17
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 Nadolol — the ingredient across all brands.

Top reported reactions

Macular Degeneration831
Nausea673
Headache603
Fatigue526
Pain513
Weight Decreased464
Diarrhoea443

Reporter sex

7,530 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization2,573
Death611
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 663 121
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
59651-0589-01 You're viewing this 100 TABLET in 1 BOTTLE (59651-589-01) 2022-06-07 Active

📄 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.
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE Angina Pectoris Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension Nadolol tablets are indicated for the treatment of hypertension, 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 nadolol 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. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION DOSAGE MUST BE INDIVIDUALIZED. NADOLOL MAY BE ADMINISTERED WITHOUT REGARD TO MEALS. Angina Pectoris The usual initial dose is 40 mg nadolol once daily.

Dosage may be gradually increased in 40 to 80 mg increments at 3 to 7 day intervals until optimum clinical response is obtained or there is pronounced slowing of the heart rate. The usual maintenance dose is 40 or 80 mg administered once daily. Doses up to 160 or 240 mg administered once daily may be needed.

The usefulness and safety in angina pectoris of dosage exceeding 240 mg per day have not been established. If treatment is to be discontinued, reduce the dosage gradually over a period of one to two weeks (see WARNINGS ). Hypertension The usual initial dose is 40 mg nadolol once daily, whether it is used alone or in addition to diuretic therapy.

Dosage may be gradually increased in 40 to 80 mg increments until optimum blood pressure reduction is achieved. The usual maintenance dose is 40 or 80 mg administered once daily. Doses up to 240 or 320 mg administered once daily may be needed.

Dosage Adjustment in Renal Failure Absorbed nadolol is excreted principally by the kidneys and, although nonrenal elimination does occur, dosage adjustments are necessary in patients with renal impairment. The following dose intervals are recommended: Creatinine Clearance (mL/min/1.73 m 2 ) Dosage Interval (hours) >50 24 31 to 50 24 to 36 10 to 30 24 to 48 <10 40 to 60

⛔ Contraindications 25 words ▾

CONTRAINDICATIONS Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see WARNINGS ).

⚠️ Warnings ~2 min read ▾

WARNINGS Cardiac Failure Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta-blockade may precipitate more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, if necessary, they can be used with caution in patients with a history of failure who are well-compensated, usually with digitalis and diuretics. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle.

IN PATIENTS WITHOUT A HISTORY OF HEART FAILURE, continued use of beta-blockers can, in some cases, lead to cardiac failure. Therefore, at the first sign or symptom of heart failure, the patient should be digitalized and/or treated with diuretics, and the response observed closely, or nadolol should be discontinued (gradually, if possible). Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal – Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy.

When discontinuing chronically administered nadolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of one to two weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, nadolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice.

Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue nadolol therapy abruptly even in patients treated only for hypertension. Nonallergic Bronchospasm (e.g., chronic bronchitis, emphysema) PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD IN GENERAL NOT RECEIVE BETA-BLOCKERS. Nadolol should be administered with caution since it may block bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta 2 receptors.

Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. Diabetes and Hypoglycemia Beta blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting).

If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment. Beta-blockade also reduces the release of insulin in response to hyperglycemia; therefore, it may be necessary to adjust the dose of antidiabetic drugs. Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism.

Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blockade which might precipitate a thyroid storm.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Most adverse effects have been mild and transient and have rarely required withdrawal of therapy. Cardiovascular Bradycardia with heart rates of less than 60 beats per minute occurs commonly, and heart rates below 40 beats per minute and/or symptomatic bradycardia were seen in about 2 of 100 patients. Symptoms of peripheral vascular insufficiency, usually of the Raynaud type, have occurred in approximately 2 of 100 patients.

Cardiac failure, hypotension, and rhythm/conduction disturbances have each occurred in about 1 of 100 patients. Single instances of first degree and third degree heart block have been reported; intensification of AV block is a known effect of beta-blockers (see also CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS ). Central Nervous System Dizziness or fatigue has been reported in approximately 2 of 100 patients; paresthesias, sedation, and change in behavior have each been reported in approximately 6 of 1000 patients.

Respiratory Bronchospasm has been reported in approximately 1 of 1000 patients (see CONTRAINDICATIONS and WARNINGS ). Gastrointestinal Nausea, diarrhea, abdominal discomfort, constipation, vomiting, indigestion, anorexia, bloating, and flatulence have been reported in 1 to 5 of 1000 patients. Miscellaneous Each of the following has been reported in 1 to 5 of 1000 patients: rash; pruritus; headache; dry mouth, eyes, or skin; impotence or decreased libido; facial swelling; weight gain; slurred speech; cough; nasal stuffiness; sweating; tinnitus; blurred vision.

Reversible alopecia has been reported infrequently. The following adverse reactions have been reported in patients taking nadolol and/or other beta-adrenergic blocking agents, but no causal relationship to nadolol has been established. Central Nervous System Reversible mental depression progressing to catatonia; visual disturbances; hallucinations; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability with slightly clouded sensorium, and decreased performance on neuropsychometrics.

Gastrointestinal Mesenteric arterial thrombosis; ischemic colitis; elevated liver enzymes. Hematologic Agranulocytosis; thrombocytopenic or nonthrombocytopenic purpura. Allergic Fever combined with aching and sore throat; laryngospasm; respiratory distress.

Miscellaneous Pemphigoid rash; hypertensive reaction in patients with pheochromocytoma; sleep disturbances; Peyronie's disease. The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with nadolol. To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 149 words ▾

DRUG INTERACTIONS When administered concurrently, the following drugs may interact with beta-adrenergic receptor blocking agents: Anesthetics, general - exaggeration of the hypotension induced by general anesthetics (see WARNINGS , Major Surgery ). Antidiabetic drugs (oral agents and insulin) - hypoglycemia or hyperglycemia; adjust dosage of antidiabetic drug accordingly (see WARNINGS , Diabetes and Hypoglycemia ). Catecholamine-depleting drugs (e.g., reserpine) - additive effect; monitor closely for evidence of hypotension and/or excessive bradycardia (e.g., vertigo, syncope, postural hypotension).

Digitalis glycosides- Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Response to Treatment for Anaphylactic Reaction - While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic.

Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

🤰 Pregnancy 92 words ▾

PREGNANCY In animal reproduction studies with nadolol, evidence of embryo- and fetotoxicity was found in rabbits, but not in rats or hamsters, at doses 5 to 10 times greater (on a mg/kg basis) than the maximum indicated human dose. No teratogenic potential was observed in any of these species. There are no adequate and well-controlled studies in pregnant women.

Nadolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates whose mothers are receiving nadolol at parturition have exhibited bradycardia, hypoglycemia, and associated symptoms.

🧒 Pediatric Use 12 words ▾

PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 113 words ▾

OVERDOSAGE Nadolol can be removed from the general circulation by hemodialysis. In addition to gastric lavage, the following measures should be employed, as appropriate. In determining the duration of corrective therapy, note must be taken of the long duration of the effect of nadolol.

Excessive Bradycardia Administer atropine (0.25 to 1 mg). If there is no response to vagal blockade, administer isoproterenol cautiously. Cardiac Failure Administer a digitalis glycoside and diuretic.

It has been reported that glucagon may also be useful in this situation. Hypotension Administer vasopressors, e.g., epinephrine or norepinephrine. (There is evidence that epinephrine may be the drug of choice.) Bronchospasm Administer a beta 2 -stimulating agent and/or a theophylline derivative.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Nadolol is a nonselective beta-adrenergic receptor blocking agent. Clinical pharmacology studies have demonstrated beta-blocking activity by showing (1) reduction in heart rate and cardiac output at rest and on exercise, (2) reduction of systolic and diastolic blood pressure at rest and on exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia. Nadolol specifically competes with beta-adrenergic receptor agonists for available beta receptor sites; it inhibits both the beta 1 receptors located chiefly in cardiac muscle and the beta 2 receptors located chiefly in the bronchial and vascular musculature, inhibiting the chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation proportionately.

Nadolol has no intrinsic sympathomimetic activity and, unlike some other beta-adrenergic blocking agents, nadolol has little direct myocardial depressant activity and does not have an anesthetic-like membrane-stabilizing action. Animal and human studies show that nadolol slows the sinus rate and depresses AV conduction. In dogs, only minimal amounts of nadolol were detected in the brain relative to amounts in blood and other organs and tissues.

Nadolol has low lipophilicity as determined by octanol/water partition coefficient, a characteristic of certain beta-blocking agents that has been correlated with the limited extent to which these agents cross the blood-brain barrier, their low concentration in the brain, and low incidence of CNS-related side effects. In controlled clinical studies, nadolol at doses of 40 to 320 mg/day has been shown to decrease both standing and supine blood pressure, the effect persisting for approximately 24 hours after dosing. The mechanism of the antihypertensive effects of beta-adrenergic receptor blocking agents has not been established; however, factors that may be involved include (1) competitive antagonism of catecholamines at peripheral (non-CNS) adrenergic neuron sites (especially cardiac) leading to decreased cardiac output, (2) a central effect leading to reduced tonic-sympathetic nerve outflow to the periphery, and (3) suppression of renin secretion by blockade of the beta-adrenergic receptors responsible for renin release from the kidneys.

While cardiac output and arterial pressure are reduced by nadolol therapy, renal hemodynamics are stable, with preservation of renal blood flow and glomerular filtration rate. By blocking catecholamine-induced increases in heart rate, velocity and extent of myocardial contraction, and blood pressure, nadolol generally reduces the oxygen requirements of the heart at any given level of effort, making it useful for many patients in the long-term management of angina pectoris. On the other hand, nadolol can increase oxygen requirements by increasing left ventricular fiber length and end diastolic pressure, particularly in patients with heart failure.

Although beta-adrenergic receptor blockade is useful in treatment of angina and hypertension, there are also situations in which sympathetic stimulation is vital. For example, in patients with severely damaged hearts, adequate ventricular function may depend on sympathetic drive. Beta-adrenergic blockade may worsen AV block by preventing the necessary facilitating effects of sympathetic activity on conduction.

Beta 2 -adrenergic blockade results in passive bronchial constriction by interfering with endogenous adrenergic bronchodilator activity in patients subject to bronchospasm and may also interfere with exogenous bronchodilators in such patients. Absorption of nadolol after oral dosing is variable, averaging about 30 percent. Peak serum concentrations of nadolol usually occur in three to four hours after oral administration and the presence of food in the gastrointestinal tract does not affect the rate or extent of nadolol absorption.

Approximately 30 percent of the nadolol present in serum is reversibly bound to plasma…

📦 How Supplied / Storage and Handling 160 words ▾

HOW SUPPLIED Nadolol Tablets USP, 20 mg are light blue colored, round, uncoated mottled tablets with scoreline on one side and ‘NA’ and ‘20’ debossed on other side. They are supplied as follows: Bottles of 100 NDC 59651-589-01 Nadolol Tablets USP, 40 mg are light blue colored, round, biconvex, uncoated mottled tablets with scoreline separating ‘NA’ and ‘40’ debossed on one side and plain on other side. They are supplied as follows: Bottles of 100 NDC 59651-251-01 Nadolol Tablets USP, 80 mg are light blue colored, round, biconvex, uncoated mottled tablets with scoreline separating ‘NA’ and ‘80’ debossed on one side and plain on other side.

They are supplied as follows: Bottles of 100 NDC 59651-252-01 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Keep container tightly closed.

Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 01/2024

📋 Description 92 words ▾

DESCRIPTION Nadolol tablets USP are a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-( tert -butylamino)-3-[(5,6,7,8-tetrahydro- cis -6,7-dihydroxy-1-naphthyl)oxy]-2-propanol. Structural formula: Nadolol is a white to off-white powder. It is soluble in methanol, sparingly soluble in ethanol, slightly soluble in acetone and isopropyl alcohol, very slightly soluble in water pH 2, pH 7 and pH 10.

Nadolol tablets USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: citric acid anhydrous, corn starch, FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose and povidone. str

💬 Information for Patients 111 words ▾

INFORMATION FOR PATIENTS Interruption or Discontinuation of Therapy Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of nadolol therapy without the physician's advice. Although cardiac failure rarely occurs in properly selected patients, patients being treated with beta-adrenergic blocking agents should be advised to consult the physician at the first sign or symptom of impending failure. The patient should also be advised of a proper course in the event of an inadvertently missed dose.

Hypoglycemia Inform patients or caregivers that there is a risk of hypoglycemia when nadolol is given to patients who are fasting or who are vomiting. Monitor for symptoms of hypoglycemia.

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