HomeNDC LookupIngredientsPropranolol Hydrochloride › 71863-0132-51
HEMANGEOL Propranolol Hydrochloride 4.28 mg/mL Solution, 50 mL — NDC 71863-0132-51 package photo

HEMANGEOL Propranolol Hydrochloride 4.28 mg/mL Solution, 50 mL

by Eton Pharmaceuticals, Inc. · 50 mL in 1 CONTAINER (71863-132-51)
NDC 71863-0132-51
🏷️ FDA NDC (as labeled) 71863-132-51 billing pads the product segment with a zero
This package
Contains50 mL Pack sizes3 compare ↓
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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) 71863-132-51
Product NDC 71863-132
11-digit billing NDC 71863013251
Application # NDA205410
SPL Set ID 4f8341ee-dac6-1ca9-e063-6394a90ac960
Established class (EPC) beta-Adrenergic Blocker
Mechanism of action Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-16
Route ORAL
Dosage form SOLUTION
Substance PROPRANOLOL HYDROCHLORIDE
GCN Seq No 072352
GCN 36526
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 HEMANGEOL 4.28 MG/ML ORAL SOLN
FDB brand name Hemangeol
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 71863-132-51 — 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 → 71863-0132-51. 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.

🏭 Manufacturer & labeler

LabelerEton Pharmaceuticals, Inc.
Application holderETON PHARMACEUTICALS INC
FDA applicationNDA205410 (NDA)
Labeler code71863
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio16 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 HEMANGEOL 4.28 MG/ML ORAL SOLN Ingredient Propranolol Hcl
📗 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

FlavorVanilla
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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.

💲 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 mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 50 ml 120 ml
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
Hemangeol 4.28 mg/mL 64370-0375-01 Pierre 1 bottle FDA listed
Hemangeol 4.28 mg/mLthis 71863-0132-51 Eton 50 ml FDA listed
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2014
First FDA approval
Mar 2014
📍
2026
Currently FDA-listed
12 years listed
🛡️
2028
Latest patent/protection listed
not a guaranteed launch date
Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2028. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 14, 2014 RLD RS ⏳ ~2.1 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8338489 — method of use (U-1496)
US 8987262 — method of use (U-1988)
2014 2016 2018 2020 2022 2024 2026 2028
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)
PatentTypeUse codeExpires
US 8338489 ↗ Method of use U-1496 Oct 16, 2028
US 8987262 ↗ Method of use U-1988 Oct 16, 2028
Common questions
Is there a generic version of HEMANGEOL 4.28 MG/ML ORAL SOLN?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for HEMANGEOL 4.28 MG/ML ORAL SOLN. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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 HEMANGEOL (this brand).

Top reported reactions

Nausea912
Product Administered To Patient Of Inappropriate Age830
Diarrhoea829
Fatigue777
Headache774
Toxicity To Various Agents661
Vomiting614

Age at onset

Neonate44
Infant255
Child34
Adolescent22
Adult1,332
Elderly674

Reporter sex

15,406 reports
Male · 31%
Female · 69%
Unknown · 0%

Serious outcomes

Hospitalization3,227
Death1,429
Life-threatening658
Disabling312
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,693 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71863-0132-12 120 mL in 1 CONTAINER (71863-132-12) 2026-04-16 Active
71863-0132-50 50 mL in 1 CONTAINER (71863-132-50) 2026-04-16 Active
71863-0132-51 You're viewing this 50 mL in 1 CONTAINER (71863-132-51) 2026-05-27 Active

Pack size FAQ

What quantity is in NDC 71863-0132-51?
NDC 71863-0132-51 contains 50 mL — 50 ml in 1 container.
What is the difference between NDC 71863-0132-51 and NDC 71863-0132-50?
Both are HEMANGEOL Propranolol Hydrochloride 4.28 mg/mL Solution — the drug itself is identical. NDC 71863-0132-51 is the 50 mL package, while NDC 71863-0132-50 is the 50 ml package.
What NDC number is used to bill for this package of HEMANGEOL Propranolol Hydrochloride 4.28 mg/mL Solution?
Bill NDC 71863-0132-51 — the 11-digit billing format is 71863013251. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 71863-132-51, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71863-0132-51, written without dashes as 71863013251. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71863-0132-51, the first segment (71863) is the labeler code FDA assigned to Eton Pharmaceuticals, Inc.; the middle segment (0132) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (51) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Eton Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 50 ml (71863-0132-50), 120 ml (71863-0132-12). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Eton Pharmaceuticals, Inc. 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.

📄 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 45 words

1 INDICATIONS AND USAGE HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. HEMANGEOL oral solution is a beta-adrenergic blocker indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. (1)

⏱️ Dosage and Administration ~1 min read

2 DOSAGE AND ADMINISTRATION Initiate treatment at ages 5 weeks to 5 months. The recommended starting dose of HEMANGEOL is 0.15 mL/kg (0.6 mg/kg) (see Table 1) twice daily, taken at least 9 hours apart. After 1 week, increase the daily dose to 0.3 mL/kg (1.1 mg/kg) twice daily.

After 2 weeks of treatment, increase the dose to 0.4 mL/kg (1.7 mg/kg) twice daily and maintain this for 6 months. Readjust the dose periodically as the child’s weight increases. To reduce the risk of hypoglycemia, administer HEMANGEOL orally during or right after a feeding.

Skip the dose if the child is not eating or is vomiting [see Warnings and Precautions (5.1)]. Monitor heart rate and blood pressure for 2 hours after HEMANGEOL initiation or dose increases [see Warnings and Precautions (5.2)]. If hemangiomas recur, treatment may be re-initiated [see Clinical Studies (14)].

HEMANGEOL is supplied with an oral dosing syringe for administration. Administration directly into the child’s mouth is recommended. Nevertheless, if necessary, the product may be diluted in a small quantity of milk or fruit juice, given in a baby’s bottle. • Initiate treatment at ages 5 weeks to 5 months.

(2) • Starting dose is 0.15 mL/kg (0.6 mg/kg) twice daily. After 1 week, increase dose to 0.3 mL/kg (1.1 mg/kg) twice daily. After 2 weeks, increase to a maintenance dose of 0.4 mL/kg (1.7 mg/kg) twice daily.(2) • Administer doses at least 9 hours apart during or after feeding.

(2) • Readjust dose for changes in the child’s weight. (2) • Monitor heart rate and blood pressure for 2 hours after the first dose or increasing dose. (2) Table 1

💊 Dosage Forms and Strengths 22 words

3 DOSAGE FORMS AND STRENGTHS Oral solution: 4.28 mg/mL propranolol hydrochloride. Alcohol-, paraben- and sugar-free. Oral solution: 4.28 mg/mL propranolol hydrochloride (3)

Contraindications 133 words

4 CONTRAINDICATIONS HEMANGEOL is contraindicated in the following conditions: • Premature infants with corrected age < 5 weeks • Infants weighing less than 2 kg • Known hypersensitivity to propranolol or any of the excipients [see Description (11)] • Asthma or history of bronchospasm • Heart rate <80 beats per minute, greater than first degree heart block, or decompensated heart failure • Blood pressure <50/30 mmHg • Pheochromocytoma • Premature infants with corrected age <5 weeks(4) • Infants weighing less than 2 kg (4) • Known hypersensitivity to propranolol or excipients(4) • Asthma or history of bronchospasm (4, 5.3, 6, 10, 17) • Bradycardia (<80 beats per minute), greater than first degree heartblock, decompensated heart failure (4, 5.2, 5.4, 10, 17) • Blood pressure <50/30 mmHg (4, 5.2, 10, 17) • Pheochromocytoma (4)

⚠️ Warnings and Cautions ~2 min read

5 WARNINGS AND PRECAUTIONS

5.1Hypoglycemia HEMANGEOL prevents the response of endogenous catecholamines to correct hypoglycemia and masks the adrenergic warning signs of hypoglycemia, particularly tachycardia, palpitations and sweating. HEMANGEOL can cause hypoglycemia, at any time during treatment. Risk is increased during a fasting period (e.g., poor oral food intake, infection, vomiting) or when glucose demands are increased (e.g., cold, stress, infections).

Withhold the dose under these conditions. Hypoglycemia may present in the form of seizures, lethargy, or coma. Discontinue HEMANGEOL if hypoglycemia develops and treat appropriately Concomitant treatment with corticosteroids may increase the risk of hypoglycemia [see Drug Interactions (7)].

5.2Bradycardia and Hypotension HEMANGEOL may cause or worsen bradycardia or hypotension. In the studies of HEMANGEOL for infantile hemangioma the mean decrease in heart rate was about 7 bpm with little effect on blood pressure. Monitor heart rate and blood pressure after treatment initiation or increase in dose. Discontinue treatment if severe (<80 beats per minute) or symptomatic bradycardia or hypotension (systolic blood pressure <50 mmHg) occurs.

5.3Bronchospasm HEMANGEOL can cause bronchospasm; do not use in patients with asthma or a history of bronchospasm. Interrupt treatment in the event of a lower respiratory tract infection associated with dyspnea and wheezing.

5.4Cardiac Failure Sympathetic stimulation supports circulatory function in patients with congestive heart failure, beta blockade may precipitate more severe failure.

5.5Increased Risk of Stroke in PHACE Syndrome By dropping blood pressure, HEMANGEOL may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies. Investigate infants with large facial infantile hemangioma for potential arteriopathy associated with PHACE syndrome prior to HEMANGEOL therapy.

5.6Hypersensitivity Beta-blockers will interfere with epinephrine used to treat serious anaphylaxis. • Hypoglycemia: Administer during or after feeding. Do not use in patients who are not able to feed or are vomiting (4, 5.1, 6, 10, 17). • Bradycardia and hypotension (4, 5.2, 17) • Bronchospasm: Avoid use in patients with asthma or lower respiratory infection. (4, 5.3, 6, 10, 17) • Increased risk of stroke in PHACE syndrome (5.5)

🤒 Adverse Reactions ~2 min read

6 ADVERSE REACTIONS

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in clinical practice. Clinical Trials Experience with HEMANGEOL in Infants with proliferating infantile hemangioma In clinical trials for proliferating infantile hemangioma, the most frequently reported adverse reactions (>10%) in infants treated with HEMANGEOL were sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhea, and vomiting.

Adverse reactions led to treatment discontinuation in fewer than 2% of treated patients. Overall, 479 patients in the pooled safety population were exposed to study drug in the clinical study program (456 in placebo-controlled trials). A total of 424 patients were treated with HEMANGEOL at doses 1.2 mg/kg/day or 3.4 mg/kg/day for 3 or 6 months.

Of these, 63% of patients were aged 91-150 days and 37% were aged 35-90 days at randomization. The following table lists according to the dosage the most common adverse reactions (treatment-emergent adverse events with an incidence at least 3% greater on one of the two doses than on placebo). The following adverse events have been observed during clinical studies, with an incidence of less than 1%: Cardiac disorders: Second degree atrioventricular heart block, in a patient with underlying conduction disorder, required definitive treatment discontinuation [see Warnings and Precautions (5.4)].

Skin and subcutaneous tissue disorders: Urticaria, alopecia Investigations: Decreased blood glucose, decreased heart rate Compassionate Use Program More than 600 infants received HEMANGEOL in a compassionate use program (CUP). Mean age at treatment initiation was 3.6 months. Mean dose of HEMANGEOL was 2.2 mg/kg/day and mean treatment duration was 7.1 months.

The adverse reactions reported in the CUP were similar to the ADRs observed during clinical trials but some were more severe.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of propranolol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are as follows: Blood and lymphatic system disorders: Agranulocytosis Psychiatric disorders: Hallucination Skin and subcutaneous tissues disorders: Purpura, dermatitis psoriasiform The most common adverse reactions to HEMANGEOL (occurring ≥ 10% of patients) were sleep disorders, aggravated respiratory tract infections, diarrhea, and vomiting.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and Medication Guide Revised: 04/2026 Table 2

🔄 Drug Interactions 92 words

7 DRUG INTERACTIONS In the absence of specific studies in children, the drug interactions with propranolol are those known in adults. Consider both the infant’s medications and those of a nursing mother. Pharmacokinetic drug interactions Impact of co-administered drugs on propranolol: CYP2D6, CYP1A2 or CYP2C19 inhibitors increase propranolol plasma concentration.

CYP1A2 inducers (phenytoin, phenobarbital) or CYP2C19 inducers (rifampin) decrease propranolol plasma concentration when co-administered. Pharmacodynamic drug interactions Corticosteroids: Patients on corticosteroids may be at increased risk of hypoglycemia because of loss of the counter-regulatory cortisol response; monitor patients for signs of hypoglycemia.

👥 Use in Specific Populations 92 words

8 USE IN SPECIFIC POPULATIONS

8.4Pediatric Use Of 460 infants with proliferating infantile hemangioma requiring systemic therapy who were treated with HEMANGEOL starting at 5 weeks to 5 months of age, 60% had complete or nearly complete resolution of their hemangioma at Week 24 [see Clinical Studies (14)]. Safety and effectiveness for infantile hemangioma have not been established in pediatric patients greater than 1 year of age.

8.6Hepatic Impairment There is no experience in infants with hepatic impairment.

8.7 Renal Impairment There is no experience in infants with renal impairment

🆘 Overdosage 160 words

10 OVERDOSAGE Few cases of propranolol overdose were reported. For a single intake, the maximum dose was 20 mg/kg. Symptomatic cases featured hypotension, hypoglycemic seizure, and restlessness/euphory/insomnia; for most cases, propranolol was maintained or reintroduced.

The toxicity of beta-blockers is an extension of their therapeutic effects: - Cardiac symptoms of mild to moderate poisoning are decreased heart rate and hypotension. Atrioventricular blocks, intraventricular conduction delays, and congestive heart failure can occur with more severe poisoning. - Bronchospasm may develop particularly in patients with asthma. - Hypoglycemia may develop and manifestations of hypoglycemia (tremor, tachycardia) may be masked by other clinical effects of beta-blocker toxicity. Support and treatment: Place the patient on a cardiac monitor, and monitor vital signs, mental status and blood glucose.

Give intravenous fluids for hypotension and atropine for bradycardia. Glucagon then catecholamines should be considered if the patient does not respond appropriately to IV fluid. Isoproterenol and aminophylline may be used for bronchospasm.

Propranolol is not dialyzable.

🧬 Clinical Pharmacology ~2 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of HEMANGEOL’s effects on infantile hemangiomas is not well understood.

12.2Pharmacodynamics Propranolol is a nonselective beta-adrenergic receptor blocking agent possessing no other autonomic nervous system activity. It specifically competes with beta-adrenergic receptor stimulating agents for available receptor sites. When access to beta-receptor sites is blocked by propranolol, chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation are decreased proportionately.

Propranolol selectively blocks beta-adrenergic receptors, leaving alpha-adrenergic responses intact. There are two well-characterized subtypes of beta receptors (beta1 and beta2); propranolol interacts with both subtypes equally. Beta1-adrenergic receptors are found primarily in the heart.

Blockade of cardiac beta1-adrenergic receptors leads to a decrease in the activity of both normal and ectopic pacemaker cells and a decrease in A-V nodal conduction velocity. Blockade of cardiac beta1-adrenergic receptors also decreases the myocardial force of contraction and may provoke cardiac decompensation in patients with minimal cardiac reserve. Beta2-adrenergic receptors are found predominantly in smooth muscle-vascular, bronchial, gastrointestinal and genitourinary.

Blockade of these receptors results in constriction. Propranolol’s beta-blocking effects are attributable to its S(-) enantiomer. Pharmacodynamic drug interactions Alpha blockers: Co-administration of beta-blockers with alpha blockers (prazosin) has been associated with prolongation of first dose hypotension and syncope.

Antidepressants: The hypotensive effect of MAO inhibitors and tricyclic antidepressants is exacerbated when administered with beta-blockers. Nonsteroidal anti-inflammatory drugs: Nonsteroidal anti-inflammatory drugs (NSAIDs) may attenuate the antihypertensive effect of beta-adrenoreceptor blocking agents. Monitor blood pressure.

12.3Pharmacokinetics Adults Absorption: Propranolol is almost completely absorbed after oral administration. However, it undergoes an extensive 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 increases the bioavailability of propranolol by about 50% with no change in time to peak concentration. Propranolol is a substrate for the intestinal efflux transporter, P-glycoprotein (P-gp). However, studies suggest that P-gp is not dose-limiting for intestinal absorption of propranolol in the usual therapeutic dose range.

Distribution: Approximately 90% of circulating propranolol is bound to plasma proteins (albumin and alpha1 acid glycoprotein). The volume of distribution of propranolol is approximately 4 L/kg. Propranolol crosses the blood-brain 7 barrier and the placenta, and is distributed into breast milk.

Propranolol is extensively metabolized with most metabolites appearing in the urine. Metabolism: Propranolol is metabolized through three primary routes: aromatic hydroxylation (mainly 4- hydroxylation), N-dealkylation followed by further side-chain oxidation, and direct glucuronidation. The percentage contributions of these routes to total metabolism are 42%, 41% and 17%, respectively, but with considerable variability between individuals.

The four major final metabolites are propranolol glucuronide, naphthyloxylactic acid and glucuronic acid, and sulfate conjugates of 4-hydroxy propranolol. In vitro studies indicated that CYP2D6 (aromatic hydroxylation), CYP1A2 (chain oxidation) and to a less extent CYP2C19 were involved in propranolol metabolism. In healthy subjects, no difference was observed between CYP2D6 extensive metabolizers (EMs) and poor metabolizers (PMs) with respect to oral clearance or elimination half-life.

Elimination: The plasma half-life of propranolol ranges from 3 to 6 hours. Less than 1…

📦 How Supplied / Storage and Handling 123 words

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied HEMANGEOL is supplied as an oral solution. Each 1 mL contains 4.28mg of propranolol hydrochloride, USP equivalent to 3.75mg of propranolol. HEMANGEOL is supplied in a carton containing one bottle with syringe adapter and one 5-mL oral dosing syringe. NDC 71863-132-12 Bottle 120 mL NDC 71863-132-50 Bottle 50 mL

16.2Storage and Handling Store HEMANGEOL at room temperature 68ºto 77ºF (20º to 25ºC); excursions permitted from 59º to 86ºF (15º to 30ºC). [See USP Controlled Room Temperature.] Do not freeze. Do not shake the bottle before use. Dispense in original container with enclosed oral dosing syringe. The product can be kept for 2 months after first opening. See instructions for using enclosed oral dosing syringe.

📋 Description 97 words

11 DESCRIPTION HEMANGEOL is an oral solution of propranolol that is alcohol free, paraben free and sugar free. Each mL of HEMANGEOL contains 4.28 mg of propranolol hydrochloride, USP equivalent to 3.75 mg of propranolol. Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (2RS)1-[(1- methylethyl)amino]-3-(naphthalene-1-yloxy)-propan-2-ol hydrochloride.

Its structural formula is shown in Figure 1: Propranolol hydrochloride is a stable, white, crystalline solid with a molecular weight of 295.8. It is readily soluble in water and ethanol. HEMANGEOL contains the following inactive ingredients: strawberry/vanilla flavorings, hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, and water. structure

💬 Medication Guide ~3 min read

MEDICATION GUIDE HEMANGEOL® (he-man je-ohl) (propranolol hydrochloride) oral solution What is the most important information I should know about HEMANGEOL? HEMANGEOL can cause serious side effects, including: • Low blood sugar (hypoglycemia), especially if your child is not taking feedings, or is vomiting. HEMANGEOL may make it more difficult to recognize the signs and symptoms of low blood sugar in your child.

To help reduce the risk of low blood sugar with HEMANGEOL: • Give HEMANGEOL during or shortly after feeding your child. • Feed your child regularly during treatment. Tell your doctor if your child has a poor appetite. • If your child is not taking feedings, for example, due to an illness or vomiting, do not give HEMANGEOL until your child is taking feedings normally again. If your child has any of the signs or symptoms of low blood sugar listed below during treatment with HEMANGEOL, stop giving your child HEMANGEOL, call your healthcare provider immediately or go to the emergency room.

If the child is conscious, give him/her a drink of liquid containing sugar. Signs or symptoms of low blood sugar include: pale, blue or purple skin color, sweating, irritability, crying for no apparent reason, irregular or fast heartbeat, poor feeding, low body temperature, unusual sleepiness, seizures, breathing stops for short periods of time, and loss of consciousness. What is HEMANGEOL?

HEMANGEOL is a prescription medicine used to treat proliferating infantile hemangioma that requires treatment with a medicine that spreads throughout the body. Who should not take HEMANGEOL? Do not give HEMANGEOL to your child if your child: • was born prematurely and has not reached the corrected age of 5 weeks • weighs less than 4 ½ pounds • is allergic to propranolol or any of the other ingredients in HEMANGEOL.

See the end of this Medication Guide for a list of ingredients in HEMANGEOL • has asthma or a history of breathing problems • has a heart problem, slow heart rate (less than 80 heart beats per minute), very low blood pressure • is at risk for low blood sugar, for example is vomiting or unable to take feedings • has high blood pressure caused by a tumor on the adrenal gland, called “pheochromocytoma” What should I tell my doctor before giving my child HEMANGEOL? Before you start giving HEMANGEOL to your child, tell your child’s doctor about all of your child’s medical conditions.

Tell your doctor about all of the medicines that your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HEMANGEOL and some medicines may interact with each other and cause serious side effects. Especially tell your doctor if your child takes a steroid medicine.

Taking a steroid medicine during treatment with HEMANGEOL may increase your child’s risk of low blood sugar. If you are breastfeeding your child, it is important to tell your doctor about all the medicines you take. Certain medicines may pass to your child through your breast-milk and interact with HEMANGEOL.

Your doctor should tell you if you should stop breastfeeding. How should I give HEMANGEOL to my child? Follow the detailed Instructions for Use that come with HEMANGEOL for information about the correct way to prepare and give a dose of HEMANGEOL. • Give HEMANGEOL to your child exactly as your doctor tells you. ● Your doctor may change the dose until it is right for your child, and as your child’s weight changes. • Always give HEMANGEOL with a feeding or right away after a feeding● HEMANGEOL is given 2 times each day, at least 9 hours apart. • If your child spits up a dose or if you are not sure your child got all of the medicine, do not give another dose.

Wait until the next scheduled dose. What are the possible side effects of HEMANGEOL? See “What is the most important information I should know about HEMANGEOL?” HEMANGEOL can cause serious side effects, including: ● New or worsening slow heart rate (bradycardia) or low blood pressure (hypotension).

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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.