HomeNDC LookupIngredientsPropranolol Hydrochloride › 70756-0095-11
Propranolol hydrochloride 20 mg Tablet, 100-count — NDC 70756-0095-11 package photo

Propranolol hydrochloride 20 mg Tablet, 100-count

by Lifestar Pharma LLC · 100 TABLET in 1 BOTTLE (70756-095-11)
NDC 70756-0095-11
🏷️ FDA NDC (as labeled) 70756-095-11 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0502 NADAC Per package$5.02 / 100 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $0.1164/unit — full pricing hub ↓
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) 70756-095-11
Product NDC 70756-095
11-digit billing NDC 70756009511
NCPDP billing unit EA — each (per item)
UNII F8A3652H1V
UPC 0370756296119, 0370756296126, 0370756095118
Application # ANDA216663
SPL Set ID 25f9b9a3-7b0b-48d2-a458-c613bedc7cab
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 2026-01-27
Route ORAL
Dosage form TABLET
Substance PROPRANOLOL HYDROCHLORIDE
GPI-14 33100040100310
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
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70756-095-11 — 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 → 70756-0095-11. 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

LabelerLifestar Pharma LLC
Application holderMANKIND PHARMA LTD
FDA applicationANDA216663 (ANDA)
Labeler code70756
First marketedJan 2026
Product typeHuman Prescription Drug
Portfolio155 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 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
  • Please don't stop propranolol on your own — even if you feel great. Stopping suddenly, especially if you have angina or any underlying heart disease, can cause a dangerous rebound...
  • Can I stop taking propranolol if I feel fine and my blood pressure is under control?
  • Bronchial asthma is actually a contraindication for propranolol, meaning it should not be used if you have asthma. Propranolol blocks receptors in your airways that help keep them...
  • I have asthma — is it safe for me to take propranolol?
📖 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.

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 Orange
ShapeRound
ImprintLS;298
Size1 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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII ZK64F7XSTX
    A red synthetic colorant made by combining D&C Red No. 27 dye with aluminum salts. It's used to give tablets, capsules, or other medicines their red or pink color.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

10 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 DailyMedingredient 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 $0.050 $5.02 / 100 tablets
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 $11.64 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jul 2026 Aug 2026 $0.053 $0.050
▼ Down 4% over the last 2 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
Propranolol Hydrochloride 20 mg 00378-0183-01 Mylan 100 tablets $0.050 AB Availability likely
Propranolol Hydrochloride 20 mg 00603-5483-21 Par 100 tablets $0.050 AB Availability likely
Propranolol Hydrochloride 20 mg 00904-7468-06 Major 50 tablets $0.050 AB Availability likely
Propranolol Hydrochloride 20 mg 50268-0663-15 AvPAK 50 tablets $0.050 AB Availability likely
Propranolol Hydrochloride 20 mg 60687-0598-01 American 100 tablets $0.050 AB Availability likely
Propranolol Hydrochloride 20 mg 60687-0937-01 American 100 tablets $0.050 AB Availability likely
Propranolol Hydrochloride 20 mg 69238-2078-01 Amneal 100 tablets $0.050 AB Availability likely
Propranolol Hydrochloride 20 mg 69292-0532-01 AMICI 100 tablets $0.050 AB Availability likely
Propranolol hydrochloride 20 mgthis 70756-0095-11 Lifestar 100 tablets $0.050 AB Availability likely
Propranolol Hydrochloride 20 mg 83980-0006-01 Ipca 100 tablets $0.050 AB Availability likely
Propranolol Hydrochloride 20 mg 00615-8426-39 NCS 30 tablets AB FDA listed
Propranolol Hydrochloride 20 mg 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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

🔬 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
70756-0095-11 You're viewing this 100 TABLET in 1 BOTTLE (70756-095-11) $0.0502 / ea $5.02 2026-01-27 Active
70756-0095-12 1000 TABLET in 1 BOTTLE (70756-095-12) $0.0502 / ea $50.19 2026-01-27 Active

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

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0502 NADAC).

Pack size FAQ

What quantity is in NDC 70756-0095-11?
NDC 70756-0095-11 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 70756-0095-11 and NDC 70756-0095-12?
Both are Propranolol hydrochloride 20 mg Tablet — the drug itself is identical. NDC 70756-0095-11 is the 100-count package, while NDC 70756-0095-12 is the 1000 tablets package.
What NDC number is used to bill for this package of Propranolol hydrochloride 20 mg Tablet?
Bill NDC 70756-0095-11 — the 11-digit billing format is 70756009511. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 ~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 is 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 is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.

Migraine Propranolol hydrochloride is 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 is 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 causes a reduction in the tremor amplitude, but not in the tremor frequency.

Propranolol hydrochloride is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis Propranolol hydrochloride improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma Propranolol hydrochloride is 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 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, when administered orally, twice a day, three times a day, or four 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 three or four times daily before meals and at bedtime.

Myocardial Infarction In the Beta-Blocker Heart Attack Trial (BHAT), the initial dose was 40 mg three times a day, with titration after 1 month to 60 mg to 80 mg three times a day as tolerated. The recommended daily dosage is 180 mg to 240 mg propranolol hydrochloride per day in divided doses. Although a three times a day regimen was used in the BHAT and a four times a day regimen in the Norwegian Multicenter Trial, there is a reasonable basis for the use of either a three times a day or twice daily regimen (see PHARMACODYNAMICS AND CLINICAL EFFECTS ).

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 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 four to six weeks after reaching the maximum dose, propranolol hydrochloride 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 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 three or four times daily before meals and at bedtime. Pheochromocytoma The usual dosage is 60 mg propranolol hydrochloride daily in divided doses for three 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 30 words

CONTRAINDICATIONS Propranolol is 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 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-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 associated with severe bradycardia requiring treatment with a pacemaker.

In one case, this result was reported after an initial dose of 5 mg propranolol. Pheochromocytoma Blocking only the peripheral dilator (beta) action of epinephrine with propranolol leaves its constrictor (alpha) action unopposed.…

🤒 Adverse Reactions 204 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.

To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 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 hydrochloride is of benefit in exaggerated physiological and essential (familial) tremor.

📦 How Supplied / Storage and Handling ~2 min read

HOW SUPPLIED Propranolol hydrochloride tablets, USP are available containing 10 mg, 20 mg, 40 mg, 60 mg or 80 mg of propranolol hydrochloride, USP. The 10 mg tablets are round, light beige to dark beige colored, mottled tablets, debossed with ''T'' and "4" on either side of the score line on one side and plain on the other side. They are available as follows: NDC 70756-094-11 bottles of 100 tablets with child-resistant closure NDC 70756-094-12 bottles of 1000 tablets The 20 mg tablets are oval, light beige to dark beige colored, mottled tablets, debossed with ''T'' and "5" on either side of the score line on one side and plain on the other side.

They are available as follows: NDC 70756-095-11 bottles of 100 tablets with child-resistant closure NDC 70756-095-12 bottles of 1000 tablets The 40 mg tablets are round, light beige to dark beige colored, mottled tablets, debossed with ''LS'' and "296" on either side of the score line on one side and plain on the other side. They are available as follows: NDC 70756-296-11 bottles of 100 tablets with child-resistant closure NDC 70756-296-51 bottles of 500 tablets The 60 mg tablets are oval, light beige to dark beige colored, mottled tablets, debossed with ''L'' and "S" on either side of the score line on one side and "297" on the other side.

They are available as follows: NDC 70756-297-11 bottles of 100 tablets with child-resistant closure NDC 70756-297-51 bottles of 500 tablets The 80 mg tablets are round, light beige to dark beige colored, mottled tablets, debossed with "LS" and "298" on either side of the score line on one side and plain on the other side. They are available as follows: NDC 70756-298-11 bottles of 100 tablets with child-resistant closure NDC 70756-298-51 bottles of 500 tablets Dispense in a well-closed, light-resistant container with child-resistant closure.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd.

Mahwah, NJ 07430 USA Made in India Revised: November 2024, V-06

📋 Description 146 words

DESCRIPTION Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as, (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its molecular and structural formulae are: Molecular Formula: C 16 H 21 NO 2 • HCl M.W. 295.80 Propranolol hydrochloride, USP is a stable, white to off-white crystalline powder which is soluble in water and in alcohol; slightly soluble in chloroform; practically insoluble in ether.

Its molecular weight is 295.80. Propranolol hydrochloride is available as 10 mg, 20 mg, 40 mg, 60 mg and 80 mg tablets for oral administration. Propranolol hydrochloride tablets, USP 10 mg, 20 mg, 40 mg, 60 mg and 80 mg contain the following inactive ingredients: anhydrous lactose, ascorbic acid, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, D&C Red No.

27 Phloxine Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, magnesium stearate, microcrystalline cellulose, and stearic acid. FDA approved dissolution test specifications differ from USP. structure

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.