HomeNDC LookupIngredientsPropranolol Hydrochloride › 69292-0532-01
Propranolol Hydrochloride 20 mg Tablet, 100-count — NDC 69292-0532-01 package photo

Propranolol Hydrochloride 20 mg Tablet, 100-count

by AMICI PHARMACEUTICALS LLC · 100 TABLET in 1 BOTTLE (69292-532-01)
NDC 69292-0532-01
🏷️ FDA NDC (as labeled) 69292-532-01 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: Medicaid pays $0.2072/unit · 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) 69292-532-01
Product NDC 69292-532
11-digit billing NDC 69292053201
NCPDP billing unit EA — each (per item)
UNII F8A3652H1V
UPC 0369292534014, 0369292538012, 0369292532010, 0369292530016 +1 more
Application # ANDA070322
SPL Set ID 8efc9fc6-6db0-43c9-892b-7423a9ba679f
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 2019-10-31
Route ORAL
Dosage form TABLET
Substance PROPRANOLOL HYDROCHLORIDE
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
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 69292-532-01 — 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 → 69292-0532-01. 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

LabelerAMICI PHARMACEUTICALS LLC
Application holderINNOGENIX LLC
FDA applicationANDA070322 (ANDA)
Labeler code69292
First marketedOct 2019
Product typeHuman Prescription Drug
Portfolio10 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 / blue / green / pink / yellow
ShapeRound
ImprintI;161
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 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 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 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.

6 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 $0.2072 $20.72 / 100 tablets
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
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.096 $0.050
▼ Down 46% over the last 24 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 mgthis 69292-0532-01 AMICI 100 tablets $0.050 AB Availability likely
Propranolol hydrochloride 20 mg 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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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 69292-0532-01, 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 – Q4 2025 · 4 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
18K
Units reimbursed last 4 qtrs
1.3M
Gross reimbursed last 4 qtrs
$268.7K
Avg / prescription
$14.89
Avg / unit
$0.2072
Latest quarter Q4 2025
2.6KRx
Medicaid pays / ea
$0.2072
gross reimbursed
vs
NADAC / ea
$0.0502
acquisition cost
=
Spread
+$0.1570
+313% 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
54% FFS 46% MCO
Fee-for-service · 9,777 Rx Managed care · 8,271 Rx
State Medicaid map
Alaska: 7,339 units · 1,001 per 100k residents AK Maine: 2,220 units · 159 per 100k residents ME Washington: 67,256 units · 861 per 100k residents WA Idaho: 6,454 units · 329 per 100k residents ID Montana: 10,320 units · 912 per 100k residents MT North Dakota: 1,997 units · 255 per 100k residents ND Minnesota: 35,489 units · 619 per 100k residents MN Wisconsin: 21,708 units · 367 per 100k residents WI Michigan: 48,576 units · 484 per 100k residents MI New York: 265,242 units · 1,355 per 100k residents NY Vermont: 2,156 units · 333 per 100k residents VT New Hampshire: 8,923 units · 636 per 100k residents NH Oregon: 20,715 units · 489 per 100k residents OR Nevada: 9,683 units · 303 per 100k residents NV Wyoming: no data reported WY South Dakota: 3,216 units · 350 per 100k residents SD Iowa: 9,249 units · 288 per 100k residents IA Illinois: 16,851 units · 134 per 100k residents IL Indiana: 10,199 units · 149 per 100k residents IN Ohio: 26,289 units · 223 per 100k residents OH Pennsylvania: 73,591 units · 568 per 100k residents PA New Jersey: 20,305 units · 219 per 100k residents NJ Massachusetts: 4,845 units · 69.2 per 100k residents MA California: 229,294 units · 588 per 100k residents CA Utah: 7,090 units · 207 per 100k residents UT Colorado: 19,657 units · 334 per 100k residents CO Nebraska: 8,008 units · 405 per 100k residents NE Missouri: 46,052 units · 743 per 100k residents MO Kentucky: 23,303 units · 515 per 100k residents KY West Virginia: 6,468 units · 365 per 100k residents WV Virginia: 16,978 units · 195 per 100k residents VA Maryland: 24,091 units · 390 per 100k residents MD Connecticut: 8,532 units · 236 per 100k residents CT Rhode Island: no data reported RI Arizona: 16,062 units · 216 per 100k residents AZ New Mexico: 9,188 units · 435 per 100k residents NM Kansas: 8,407 units · 286 per 100k residents KS Arkansas: 8,135 units · 265 per 100k residents AR Tennessee: 14,705 units · 206 per 100k residents TN North Carolina: 17,265 units · 159 per 100k residents NC South Carolina: 7,832 units · 146 per 100k residents SC Delaware: 2,460 units · 239 per 100k residents DE Oklahoma: 13,050 units · 322 per 100k residents OK Louisiana: 19,791 units · 433 per 100k residents LA Mississippi: 4,620 units · 157 per 100k residents MS Alabama: 15,390 units · 301 per 100k residents AL Georgia: 19,702 units · 179 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 17,641 units · 57.8 per 100k residents TX Florida: 20,964 units · 92.7 per 100k residents FL
Units reimbursed · per 100k residents
57.81,355
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 New York 1,355 /100k
2 Alaska 1,001 /100k
3 Montana 912 /100k
4 Washington 861 /100k
5 Missouri 743 /100k
6 New Hampshire 636 /100k
7 Minnesota 619 /100k
8 California 588 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets69292-0532-10 63,095 Rx · $806,241
100 tablets this page69292-0532-01 18,048 Rx · $268,706
Drug total (last 4 qtrs): 81,143 Rx · 6,209,035 units · $1,074,947 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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
69292-0532-01 You're viewing this 100 TABLET in 1 BOTTLE (69292-532-01) $0.0502 / ea $5.02 2019-10-31 Active
69292-0532-10 1000 TABLET in 1 BOTTLE (69292-532-10) $0.0502 / ea $50.19 2019-10-31 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).

This pack accounts for about 22% of this product's recent Medicaid fills; most go to the 1000 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 69292-0532-01?
NDC 69292-0532-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 69292-0532-01 and NDC 69292-0532-10?
Both are Propranolol Hydrochloride 20 mg Tablet — the drug itself is identical. NDC 69292-0532-01 is the 100-count package, while NDC 69292-0532-10 is the 1000 tablets package.
What NDC number is used to bill for this package of Propranolol Hydrochloride 20 mg Tablet?
Bill NDC 69292-0532-01 — the 11-digit billing format is 69292053201. 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, USP are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets, USP are not indicated in the management of hypertensive emergencies.

Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride tablets, USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride tablets, USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction Propranolol hydrochloride tablets, USP 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, USP 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, USP 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 causes a reduction in the tremor amplitude, but not in the tremor frequency.

Propranolol hydrochloride tablets, USP are not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis Propranolol hydrochloride tablets, USP improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma Propranolol hydrochloride tablets, USP 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 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 t.i.d., with titration after 1 month to 60 mg to 80 mg t.i.d. as tolerated. The recommended daily dosage is 180 mg to 240 mg propranolol hydrochloride per day in divided doses. Although a t.i.d. regimen was used in the 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 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 T4 and reverse T3 and decreasing T3. 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. In th…

🤒 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 Innogenix, LLC. at 1-844-466-6469 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 186 words

Pregnancy Teratogenic Effects 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 hydrochloride tablets 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 83 words

Geriatric Use Clinical studies of propranolol hydrochloride 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 hydrochloride is of benefit in exaggerated physiological and essential (familial) tremor.

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

📦 How Supplied / Storage and Handling 187 words

HOW SUPPLIED Propranolol Hydrochloride Tablets, USP 10 mg – Orange, round biconvex scored tablets with “I” “156” on one side and other side plain. They are available as follows: Bottles of 100 Tablets NDC 69292-530-01 Bottles of 1000 Tablets NDC 69292-530-10 20 mg – Blue, round biconvex scored tablets with “I” “157” on one side and other side plain. They are available as follows: Bottles of 100 Tablets NDC 69292-532-01 Bottles of 1000 Tablets NDC 69292-532-10 40 mg – Green, round biconvex scored tablets with “I” “159” on one side and other side plain.

They are available as follows: Bottles of 100 Tablets NDC 69292-534-01 Bottles of 1000 Tablets NDC 69292-534-10 60 mg – Pink, round biconvex scored tablets with “I” “160” on one side and other side plain. They are available as follows: Bottles of 100 Tablets NDC 69292-536-01 Bottles of 1000 Tablets NDC 69292-536-10 80 mg – Yellow, round biconvex scored tablets with “I” “161” on one side and other side plain. They are available as follows: Bottles of 100 Tablets NDC 69292-538-01 Bottles of 500 Tablets NDC 69292-538-50 Bottles of 1000 Tablets NDC 69292-538-10

📦 Storage and Handling 44 words

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). PROTECT FROM LIGHT. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

📋 Description 139 words

DESCRIPTION Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is: C ​16 ​H ​21 ​NO ​2 ​HCl M.W. 295.80 Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and in ethanol.

Propranolol hydrochloride tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol hydrochloride tablets, USP also contain colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Color additives include FD&C Yellow no.

6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (40 mg and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no.

40 aluminum lake (60 mg). chemical-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.