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Propranolol Hydrochloride 20 mg Tablet, 90-count — NDC 43353-0961-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Propranolol Hydrochloride 20 mg Tablet, 90-count — NDC 43353-961-60 (Billing 43353-0961-60)

by Aphena Pharma Solutions - Tennessee, LLC · 90 TABLET in 1 BOTTLE, PLASTIC

This is a package of 90 tablets of Propranolol Hydrochloride 20 mg Tablet from Aphena Pharma Solutions - Tennessee, LLC, marketed since Nov 1985 and currently FDA-listed. It is this product's only package size.

NDC 43353-0961-60
🏷️ FDA NDC (as labeled) 43353-961-60 billing pads the product segment with a zero
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 →

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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) 43353-961-60
Product NDC 43353-961
11-digit billing NDC 43353096160
NCPDP billing unit EA — each (per item)
RxCUI 856457, 856519
UNII F8A3652H1V
Application # ANDA070213
SPL Set ID 7da9bb37-cc22-4eff-8de0-429f64cb599e
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 1985-11-19
Route ORAL
Dosage form TABLET
Substance PROPRANOLOL HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 33100040100310
GPI class Propranolol HCl
GCN Seq No 005124
GCN 20631
HICL code 002101
Ingredient (HICL) Propranolol Hcl
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 12:16.08.04
AHFS class Non-Sel. Beta-Adrenergic Blocking Agents
FDB label name PROPRANOLOL 20 MG TABLET
FDB brand name Propranolol Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 005124
  • GCN: 20631
  • GPI-14 (Medi-Span): 33100040100310
  • HICL (First Databank): 002101
  • AHFS class code: 12:16.08.04
  • RxCUI (RxNorm): 856457
Why two NDCs? The FDA registers this code as 43353-961-60 — 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 → 43353-0961-60. 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.

Clinical

Label name PROPRANOLOL 20 MG TABLET Ingredient Propranolol Hcl
📖 What it is MedlinePlus · NLM

Propranolol is used to treat high blood pressure irregular heartbeats pheochromocytoma (tumor on a small gland near the kidneys) certain types of tremor hypertrophic subaortic stenosis (a heart muscle disease angina (chest pain) migraine headaches Propranolol is also used to improve survival after a heart attack. Propranolol 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
  • It depends on the product. Tablets and solution treat high blood pressure, angina, atrial fibrillation, migraine prevention and essential tremor, and lower death risk after a heart...
  • Please don't stop on your own. Stopping suddenly can worsen angina or even trigger a heart attack. If you need to stop, your prescriber will taper the dose over at least a few week...
  • Some people feel tired, lightheaded or have a slow heartbeat. Others get vivid dreams, nausea or stomach upset. Call your doctor for wheezing, fainting, swelling, a severe rash or...
  • For InnoPran XL and Inderal XL, take it at bedtime, consistently with food or without. Protein-rich food can increase how much propranolol you absorb, so keep your routine steady....
📖 Read our full Propranolol guide →
1
Nutrient depletion considerations

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

🧪 Full Propranolol Hydrochloride 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 $0.1164 $10.48 / 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
43353-0961-60 You're viewing this Main listing 90 TABLET in 1 BOTTLE, PLASTIC 2014-09-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Propranolol Hydrochloride 20 mg 00378-0183-01 Mylan 100 tablets $0.049 AB Availability likely —
Propranolol Hydrochloride 20 mg 00603-5483-21 Par 100 tablets $0.049 AB Availability likely —
Propranolol Hydrochloride 20 mg 00904-7468-06 Major 50 tablets $0.049 AB Availability likely —
Propranolol Hydrochloride 20 mg 50268-0663-15 AvPAK 50 tablets $0.049 AB Availability likely —
Propranolol Hydrochloride 20 mg 60687-0598-01 American 100 tablets $0.049 AB Availability likely —
Propranolol Hydrochloride 20 mg 60687-0937-01 American 100 tablets $0.049 AB Availability likely —
Propranolol Hydrochloride 20 mg 69238-2078-01 Amneal 100 tablets $0.049 AB Availability likely —
Propranolol Hydrochloride 20 mg 69292-0532-01 AMICI 100 tablets $0.049 AB Availability likely —
Propranolol hydrochloride 20 mg 70756-0095-11 Lifestar 100 tablets $0.049 AB Availability likely —
Propranolol Hydrochloride 20 mg 83980-0006-01 Ipca 100 tablets $0.049 AB Availability likely —
Propranolol Hydrochloride 20 mg 00615-8426-39 NCS 30 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mgthis 43353-0961-60 Aphena 90 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 50090-7101-01 A-S 100 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 50090-7620-00 A-S 30 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 51407-0236-01 Golden 100 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 51655-0302-26 Northwind 90 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 51655-0426-26 Northwind 90 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 55154-2646-00 Cardinal 10 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 60760-0545-60 St. 60 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 60760-0731-60 St. 60 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 63629-2277-01 Bryant 1000 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 67046-1657-03 Coupler 30 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 68788-4089-01 Preferred 100 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 68788-7791-03 Preferred 30 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 68788-8595-03 Preferred 30 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 70518-3466-00 REMEDYREPACK 100 tablets — AB Discontinued —
Propranolol Hydrochloride 20 mg 70518-4454-00 REMEDYREPACK 30 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 71205-0590-30 Proficient 30 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 71335-0082-01 Bryant 20 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 71335-1712-01 Bryant 20 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 71335-2299-01 Bryant 1000 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 71335-2371-01 Bryant 20 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 71335-3097-01 Bryant 20 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 71610-0339-45 Aphena 45 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 71610-0987-53 Aphena 60 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 72162-1176-00 Bryant 1000 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 72789-0280-30 PD-Rx 30 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 72789-0423-30 PD-Rx 30 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 76420-0384-00 Asclemed 1000 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 82804-0284-60 Proficient 60 tablets — AB FDA listed —
Propranolol Hydrochloride 20 mg 82868-0003-30 Northwind 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

🏛️
1985
On the market since
Nov 1985
📍
2026
Currently FDA-listed
41 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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderMYLAN PHARMACEUTICALS INC
FDA applicationANDA070213 (ANDA)
Labeler code43353
First marketedNov 1985
Product typeHuman Prescription Drug
Portfolio800 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Hypertension Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.

Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction Propranolol hydrochloride tablets are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.

Migraine Propranolol hydrochloride tablets are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor Propranolol hydrochloride tablets are indicated in the management of familial or hereditary essential tremor.

Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol hydrochloride tablets cause a reduction in the tremor amplitude but not in the tremor frequency.

Propranolol hydrochloride tablets are not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis Propranolol hydrochloride tablets improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma Propranolol hydrochloride tablets are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION General Because of the variable bioavailability of propranolol, the dose should be individualized based on response. Hypertension The usual initial dosage is 40 mg propranolol hydrochloride tablets twice daily, whether used alone or added to a diuretic. Dosage may be increased gradually until adequate blood pressure control is achieved.

The usual maintenance dosage is 120 mg to 240 mg per day. In some instances a dosage of 640 mg a day may be required. The time needed for full antihypertensive response to a given dosage is variable and may range from a few days to several weeks.

While twice-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, some patients, especially when lower doses are used, may experience a modest rise in blood pressure toward the end of the 12-hour dosing interval. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. If control is not adequate, a larger dose, or 3-times-daily therapy may achieve better control.

Angina Pectoris Total daily doses of 80 mg to 320 mg propranolol hydrochloride tablets, when administered orally, twice a day, 3 times a day, or 4 times a day, have been shown to increase exercise tolerance and to reduce ischemic changes in the ECG. If treatment is to be discontinued, reduce dosage gradually over a period of several weeks. (See WARNINGS .) Atrial Fibrillation The recommended dose is 10 mg to 30 mg propranolol hydrochloride tablets 3 or 4 times daily before meals and at bedtime.

Myocardial Infarction In the Beta-Blocker Heart Attack Trial (BHAT), the initial dose was 40 mg t.i.d., with titration after one month to 60 mg to 80 mg t.i.d. as tolerated. The recommended daily dosage is 180 mg to 240 mg propranolol hydrochloride tablets per day in divided doses. Although a t.i.d. regimen was used in BHAT and a q.i.d. regimen in the Norwegian Multicenter Trial, there is a reasonable basis for the use of either a t.i.d. or b.i.d. regimen (see CLINICAL PHARMACOLOGY ).

The effectiveness and safety of daily dosages greater than 240 mg for prevention of cardiac mortality have not been established. However, higher dosages may be needed to effectively treat coexisting diseases such as angina or hypertension (see above). Migraine The initial dose is 80 mg propranolol hydrochloride tablets daily in divided doses.

The usual effective dose range is 160 mg to 240 mg per day. The dosage may be increased gradually to achieve optimum migraine prophylaxis. If a satisfactory response is not obtained within 4 to 6 weeks after reaching the maximum dose, propranolol hydrochloride tablet therapy should be discontinued.

It may be advisable to withdraw the drug gradually over a period of several weeks. Essential Tremor The initial dosage is 40 mg propranolol hydrochloride tablets twice daily. Optimum reduction of essential tremor is usually achieved with a dose of 120 mg per day.

Occasionally, it may be necessary to administer 240 mg to 320 mg per day. Hypertrophic Subaortic Stenosis The usual dosage is 20 mg to 40 mg propranolol hydrochloride tablets 3 or 4 times daily before meals and at bedtime. Pheochromocytoma The usual dosage is 60 mg propranolol hydrochloride tablets daily in divided doses for 3 days prior to surgery as adjunctive therapy to alpha-adrenergic blockade.

For the management of inoperable tumors, the usual dosage is 30 mg daily in divided doses as adjunctive therapy to alpha-adrenergic blockade.

⛔ Contraindications 32 words ▾

CONTRAINDICATIONS Propranolol hydrochloride tablets are contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.

⚠️ Warnings ~2 min read ▾

WARNINGS Angina Pectoris There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. Therefore, when discontinuance of propranolol is planned, the dosage should be gradually reduced over at least a few weeks and the patient should be cautioned against interruption or cessation of therapy without the physician’s advice. If propranolol therapy is interrupted and exacerbation of angina occurs, it usually is advisable to reinstitute propranolol therapy and take other measures appropriate for the management of angina pectoris.

Since coronary artery disease may be unrecognized, it may be prudent to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease who are given propranolol for other indications. Hypersensitivity and Skin Reactions Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been associated with the administration of propranolol (see ADVERSE REACTIONS ). Cutaneous reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and urticaria, have been reported with use of propranolol (see ADVERSE REACTIONS ).

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, some have been shown to be highly beneficial when used with close follow-up in patients with a history of failure who are well compensated and are receiving additional therapies, including diuretics as needed. 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. Nonallergic Bronchospasm (e.g., Chronic Bronchitis, Emphysema) In general, patients with bronchospastic lung disease should not receive beta-blockers. Propranolol should be administered with caution in this setting since it may provoke a bronchial asthmatic attack by blocking bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta-receptors.

Major Surgery The necessity or desirability of withdrawal of beta-blocking therapy prior to major surgery is controversial. It should be noted, however, that the impaired ability of the heart to respond to reflex adrenergic stimuli in propranolol-treated patients may augment the risks of general anesthesia and surgical procedures. Propranolol is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol.

However, such patients may be subject to protracted severe hypotension. Diabetes and Hypoglycemia Beta-adrenergic blockade may prevent the appearance of certain premonitory signs and symptoms (pulse rate and pressure changes) of acute hypoglycemia, especially in labile insulin-dependent diabetics. In these patients, it may be more difficult to adjust the dosage of insulin.

Propranolol therapy, particularly when given to infants and children, diabetic or not, has been associated with hypoglycemia especially during fasting as in preparation for surgery. Hypoglycemia has been reported in patients taking propranolol after prolonged physical exertion and in patients with renal insufficiency. Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism.

Therefore, abrupt withdrawal of propranolol may be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Propranolol may change thyroid-function tests, increasing T 4 and reverse T 3 and decreasing T 3 . Wolff-Parkinson-White Syndrome Beta-adrenergic blockade in patients with Wolf-Parkinson-White Syndrome and tachycardia has been a…

🤒 Adverse Reactions 187 words ▾

ADVERSE REACTIONS The following adverse events were observed and have been reported in patients using propranolol. Cardiovascular: Bradycardia; congestive heart failure; intensification of AV block; hypotension; paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type. Central Nervous System: Light-headedness, mental depression manifested by insomnia, lassitude, weakness, fatigue; catatonia; visual disturbances; hallucinations; vivid dreams; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics.

For immediate-release formulations, fatigue, lethargy, and vivid dreams appear dose related. Gastrointestinal: Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis. Allergic: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat; laryngospasm, and respiratory distress.

Respiratory: Bronchospasm. Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura. Autoimmune: Systemic lupus erythematosus (SLE).

Skin and Mucous Membranes: Stevens-Johnson Syndrome, toxic epidermal necrolysis, dry eyes, exfoliative dermatitis, erythema multiforme, urticaria, alopecia, SLE-like reactions, and psoriasiform rashes. Oculomucocutaneous syndrome involving the skin, serous membranes and conjunctivae reported for a beta-blocker (practolol) have not been associated with propranolol. Genitourinary: Male impotence; Peyronie’s disease.

🔄 Drug Interactions ~2 min read ▾

Drug Interactions Caution should be exercised when propranolol is administered with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways. Coadministration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see CLINICAL PHARMACOLOGY: Drug Interactions ). Cardiovascular Drugs Antiarrhythmics Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.

Quinidine increases the concentration of propranolol and produces greater degrees of clinical beta-blockade and may cause postural hypotension. Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta-blockers such as propranolol. The clearance of lidocaine is reduced with administration of propranolol.

Lidocaine toxicity has been reported following coadministration with propranolol. Caution should be exercised when administering propranolol with drugs that slow A-V nodal conduction, e.g. digitalis, lidocaine and calcium channel blockers. Digitalis Glycosides Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate.

Concomitant use can increase the risk of bradycardia. Calcium Channel Blockers Caution should be exercised when patients receiving a beta-blocker are administered a calcium channel-blocking drug with negative inotropic and/or chronotropic effects. Both agents may depress myocardial contractility or atrioventricular conduction.

There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta-blockers. Coadministration of propranolol and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high degree heart block, and heart failure. ACE Inhibitors When combined with beta-blockers, ACE inhibitors can cause hypotension, particularly in the setting of acute myocardial infarction.

The antihypertensive effects of clonidine may be antagonized by beta-blockers. Propranolol should be administered cautiously to patients withdrawing from clonidine. Alpha Blockers Prazosin has been associated with prolongation of first dose hypotension in the presence of beta-blockers.

Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin. Reserpine Patients receiving catecholamine-depleting drugs, such as reserpine, should be closely observed for excessive reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension. Inotropic Agents Patients on long-term therapy with propranolol may experience uncontrolled hypertension if administered epinephrine as a consequence of unopposed alpha-receptor stimulation.

Epinephrine is therefore not indicated in the treatment of propranolol overdose (see OVERDOSAGE ). Isoproterenol and Dobutamine Propranolol is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol. Also, propranolol may reduce sensitivity to dobutamine stress echocardiography in patients undergoing evaluation for myocardial ischemia.

Non-Cardiovascular Drugs Nonsteroidal Anti-Inflammatory Drugs Nonsteroidal anti-inflammatory drugs (NSAIDs) have been reported to blunt the antihypertensive effect of beta-adrenoreceptor blocking agents. Administration of indomethacin with propranolol may reduce the efficacy of propranolol in reducing blood pressure and heart rate. Antidepressants The hypotensive effects of MAO inhibitors or tricyclic antidepressants may be exacerbated when administered with beta-blockers by interfering with the beta-blocking activity of propranolol.

Anesthetic Agents Methoxyflurane and trichloroethylene may depress myocardial contractility when administered with propranolol. Warfarin Propran…

🤰 Pregnancy 182 words ▾

Pregnancy Pregnancy Category C In a series of reproductive and developmental toxicology studies, propranolol hydrochloride was given to rats by gavage or in the diet throughout pregnancy and lactation. At doses of 150 mg/kg/day, but not at doses of 80 mg/kg/day (equivalent to the MRHD on a body surface area basis), treatment was associated with embryotoxicity (reduced litter size and increased resorption rates) as well as neonatal toxicity (deaths). Propranolol hydrochloride also was administered (in the feed) to rabbits (throughout pregnancy and lactation) at doses as high as 150 mg/kg/day (about 5 times the maximum recommended human oral daily dose).

No evidence of embryo or neonatal toxicity was noted. There are no adequate and well controlled studies in pregnant women. Intrauterine growth retardation, small placentas, and congenital abnormalities have been reported in neonates whose mothers received propranolol during pregnancy.

Neonates whose mothers received propranolol at parturition have exhibited bradycardia, hypoglycemia, and/or respiratory depression. Adequate facilities for monitoring such infants at birth should be available. Propranolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 32 words ▾

Pediatric Use Safety and effectiveness of propranolol in pediatric patients have not been established. Bronchospasm and congestive heart failure have been reported coincident with the administration of propranolol therapy in pediatric patients.

🧓 Geriatric Use 82 words ▾

Geriatric Use Clinical studies of propranolol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 156 words ▾

OVERDOSAGE Propranolol is not significantly dialyzable. In the event of overdosage or exaggerated response, the following measures should be employed: General If ingestion is or may have been recent, evacuate gastric contents, taking care to prevent pulmonary aspiration. Supportive Therapy Hypotension and bradycardia have been reported following propranolol overdose and should be treated appropriately.

Glucagon can exert potent inotropic and chronotropic effects and may be particularly useful for the treatment of hypotension or depressed myocardial function after a propranolol overdose. Glucagon should be administered as 50 to 150 mcg/kg intravenously followed by continuous drip of 1 to 5 mg/hour for positive chronotropic effect. Isoproterenol, dopamine or phosphodiesterase inhibitors may also be useful.

Epinephrine, however, may provoke uncontrolled hypertension. Bradycardia can be treated with atropine or isoproterenol. Serious bradycardia may require temporary cardiac pacing.

The electrocardiogram, pulse, blood pressure, neurobehavioral status and intake and output balance must be monitored. Isoproterenol and aminophylline may be used for bronchospasm.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY General Propranolol is a nonselective beta-adrenergic receptor blocking agent possessing no other autonomic nervous system activity. It specifically competes with beta-adrenergic receptor agonist agents for available receptor sites. When access to beta-receptor sites is blocked by propranolol, the chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation are decreased proportionately.

At dosages greater than required for beta-blockade, propranolol also exerts a quinidine-like or anesthetic-like membrane action, which affects the cardiac action potential. The significance of the membrane action in the treatment of arrhythmias is uncertain. Mechanism of Action The mechanism of the antihypertensive effect of propranolol has not been established.

Factors that may contribute to the antihypertensive action include: (1) decreased cardiac output, (2) inhibition of renin release by the kidneys, and (3) diminution of tonic sympathetic nerve outflow from vasomotor centers in the brain. Although total peripheral resistance may increase initially, it readjusts to or below the pretreatment level with chronic use of propranolol. Effects of propranolol on plasma volume appear to be minor and somewhat variable.

In angina pectoris, propranolol generally reduces the oxygen requirement of the heart at any given level of effort by blocking the catecholamine-induced increases in the heart rate, systolic blood pressure, and the velocity and extent of myocardial contraction. Propranolol may increase oxygen requirements by increasing left ventricular fiber length, end diastolic pressure, and systolic ejection period. The net physiologic effect of beta-adrenergic blockade is usually advantageous and is manifested during exercise by delayed onset of pain and increased work capacity.

Propranolol exerts its antiarrhythmic effects in concentrations associated with beta-adrenergic blockade, and this appears to be its principal antiarrhythmic mechanism of action. In dosages greater than required for beta-blockade, propranolol also exerts a quinidine-like or anesthetic-like membrane action, which affects the cardiac action potential. The significance of the membrane action in the treatment of arrhythmias is uncertain.

The mechanism of the antimigraine effect of propranolol has not been established. Beta-adrenergic receptors have been demonstrated in the pial vessels of the brain. The specific mechanism of propranolol’s antitremor effects has not been established, but beta-2 (noncardiac) receptors may be involved.

A central effect is also possible. Clinical studies have demonstrated that propranolol is of benefit in exaggerated physiological and essential (familial) tremor. Pharmacokinetics and Drug Metabolism Absorption Propranolol is highly lipophilic and almost completely absorbed after oral administration.

However, it undergoes high first-pass metabolism by the liver and on average, only about 25% of propranolol reaches the systemic circulation. Peak plasma concentrations occur about 1 to 4 hours after an oral dose. Administration of protein-rich foods increase the bioavailability of propranolol by about 50% with no change in time to peak concentration, plasma binding, half-life, or the amount of unchanged drug in the urine.

Distribution Approximately 90% of circulating propranolol is bound to plasma proteins (albumin and alpha 1 acid glycoprotein). The binding is enantiomer-selective. The S(-)-enantiomer is preferentially bound to alpha 1 glycoprotein and the R(+)-enantiomer preferentially bound to albumin.

The volume of distribution of propranolol is approximately 4 liters/kg. Propranolol crosses the blood-brain barrier and the placenta, and is distributed into breast milk. Metabolism and Elimination Propranolol is extensively metabolized with most metabolites appearing in the urine.

Propranolol is metabolized through three primary routes: aromatic hydroxylation (mainly 4-hydroxylation), N-dealkylation follow…

🧬 Mechanism of Action ~1 min read ▾

Mechanism of Action The mechanism of the antihypertensive effect of propranolol has not been established. Factors that may contribute to the antihypertensive action include: (1) decreased cardiac output, (2) inhibition of renin release by the kidneys, and (3) diminution of tonic sympathetic nerve outflow from vasomotor centers in the brain. Although total peripheral resistance may increase initially, it readjusts to or below the pretreatment level with chronic use of propranolol.

Effects of propranolol on plasma volume appear to be minor and somewhat variable. In angina pectoris, propranolol generally reduces the oxygen requirement of the heart at any given level of effort by blocking the catecholamine-induced increases in the heart rate, systolic blood pressure, and the velocity and extent of myocardial contraction. Propranolol may increase oxygen requirements by increasing left ventricular fiber length, end diastolic pressure, and systolic ejection period.

The net physiologic effect of beta-adrenergic blockade is usually advantageous and is manifested during exercise by delayed onset of pain and increased work capacity. Propranolol exerts its antiarrhythmic effects in concentrations associated with beta-adrenergic blockade, and this appears to be its principal antiarrhythmic mechanism of action. In dosages greater than required for beta-blockade, propranolol also exerts a quinidine-like or anesthetic-like membrane action, which affects the cardiac action potential.

The significance of the membrane action in the treatment of arrhythmias is uncertain. The mechanism of the antimigraine effect of propranolol has not been established. Beta-adrenergic receptors have been demonstrated in the pial vessels of the brain.

The specific mechanism of propranolol’s antitremor effects has not been established, but beta-2 (noncardiac) receptors may be involved. A central effect is also possible. Clinical studies have demonstrated that propranolol is of benefit in exaggerated physiological and essential (familial) tremor.

📦 How Supplied / Storage and Handling ~1 min read ▾

HOW SUPPLIED Propranolol hydrochloride tablets, USP are available containing 10 mg, 20 mg, 40 mg, 60 mg and 80 mg of propranolol hydrochloride, USP. The 10 mg tablets are orange, round, scored tablets debossed with MYLAN above the score and 182 below the score on one side of the tablet and 10 on the other side. They are available as follows: NDC 0378-0182-01 bottles of 100 tablets NDC 0378-0182-10 bottles of 1000 tablets The 20 mg tablets are blue, round, scored tablets debossed with MYLAN above the score and 183 below the score on one side of the tablet and 20 on the other side.

They are available as follows: NDC 0378-0183-01 bottles of 100 tablets NDC 0378-0183-10 bottles of 1000 tablets The 40 mg tablets are green, round, scored tablets debossed with MYLAN above the score and 184 below the score on one side of the tablet and 40 on the other side. They are available as follows: NDC 0378-0184-01 bottles of 100 tablets NDC 0378-0184-10 bottles of 1000 tablets The 60 mg tablets are light purple, round, scored tablets debossed with MYLAN above the score and PR60 below the score on one side of the tablet and 60 on the other side.

They are available as follows: NDC 0378-0187-01 bottles of 100 tablets NDC 0378-0187-05 bottles of 500 tablets The 80 mg tablets are yellow, round, scored tablets debossed with MYLAN above the score and 185 below the score on one side of the tablet and 80 on the other side. They are available as follows: NDC 0378-0185-01 bottles of 100 tablets NDC 0378-0185-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED OCTOBER 2009 PRAN:R26

📋 Description 158 words ▾

DESCRIPTION Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are: Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80.

Each tablet for oral administration contains 10 mg, 20 mg, 40 mg, 60 mg or 80 mg of propranolol hydrochloride and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The coloring agents are: 10 mg: FD&C Yellow No. 6 Aluminum Lake 20 mg: FD&C Blue No.

1 Aluminum Lake 40 mg: FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No.

10 Aluminum Lake 60 mg: FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake 80 mg: FD&C Yellow No.

6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake Structural Formula

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

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 Propranolol Hydrochloride — the ingredient across all brands.

Top reported reactions

Nausea4,551
Headache3,962
Fatigue3,912
Diarrhoea3,292
Dizziness3,221
Vomiting2,780
Dyspnoea2,675

Age at onset

Neonate316
Infant487
Child144
Adolescent130
Adult6,358
Elderly3,109

Reporter sex

71,669 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization21,999
Life-threatening4,071
Disabling2,482
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 6,686 3,218
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.

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 Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC 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.
← 43353-0953-53 · Aphena 43353-0978-92 · Aphena →
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.