NDC 51662-1363-1 (billing 51662-1363-01) — AMIODARONE HCI 50 mg/mL, 3 mL

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51662-1363-1

Product NDC 51662-1363

11-digit billing NDC 51662136301

RxCUI 1663224

UNII 976728SY6Z

UPC 0363323616038

Application # ANDA075761

SPL Set ID 993b2557-6774-bb7a-e053-2995a90a0503

Established class (EPC) Antiarrhythmic

Mechanism of action Cytochrome P450 1A2 Inhibitors; Cytochrome P450 2C9 Inhibitors; Cytochrome P450 2D6 Inhibitors; Cytochrome P450 3A4 Inhibitors; P-Glycoprotein Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2019-12-08

Route INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance AMIODARONE HYDROCHLORIDE

TE code (Orange Book) AP · RLD · RS

Quick answers

RxCUI (RxNorm): 1663224

Why two NDCs? The FDA registers this code as 51662-1363-1 — a 5-4-1 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 package segment → 51662-1363-01. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 3, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic

Drug family (ATC) Antiarrhythmics, class III

How it works Cytochrome P450 2D6 Inhibitors, Cytochrome P450 1A2 Inhibitors, P-Glycoprotein Inhibitors, Cytochrome P450 2C9 Inhibitors

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.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

📗 Our plain-language guide HelloPharmacist

It treats life-threatening ventricular rhythm problems, specifically ventricular fibrillation and unstable ventricular tachycardia. It is usually used when other heart rhythm medic...
Take them the same way with respect to meals each day. Your prescriber may start you on a higher loading amount and then lower it. If the daily total is high or your stomach is ups...
Call right away for a new cough, shortness of breath, fever, yellow skin or eyes, dark urine, fainting, a very slow or irregular heartbeat, or vision changes. These can signal lung...
No, avoid it. Grapefruit juice raises amiodarone levels in your body. Also check with me before starting any new medicine, since amiodarone interacts with many, including warfarin,...

📖 Read our full Amiodarone guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 3, 2026

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 system	Per mL	Per 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.
Medicare Part B allowsASP · J0282	$0.400 / J0282 unit	—

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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Billing & reimbursement

FDA NDC (as labeled)51662-1363-1

11-digit billing NDC51662-1363-01

Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)

HCPCS J-codeJ0282

DescriptorInjection, amiodarone hydrochloride, 30 mg

Billing units / pkg5 units

How the units are derivedThis package is 3; the HCPCS unit is 30 MG, so one package = 5 billing units.

Medicare Part B spend (2025 (Q1-Q4))$1,417 · 38 claims · $37.30 per claim (all NDCs under J0282)

Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk

Where does this data come from?

The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
DMEPDAC NDC-HCPCS crosswalk
openFDA NSDE billing units · refreshed Sep 7, 2026

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
51662-1363-01 You're viewing this Main listing	3 mL in 1 VIAL, SINGLE-DOSE	2019-12-08	—	Active

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Amiodarone Hydrochloride 50 mg/mL 63323-0616-03	Fresenius	25 vials	$0.521	AP	Availability likely	—
Amiodarone Hydrochloride 50 mg/mL 00143-9875-10	Hikma	10 vials	—	AP	FDA listed	—
Amiodarone Hydrochloride 50 mg/mL 00404-9772-03	Henry	1 vial	—	AP	FDA listed	—
Amiodarone Hydrochloride 50 mg/mL 51662-1205-01	HF	3 ml	—	AP	FDA listed	—
Amiodarone Hci 50 mg/mLthis 51662-1363-01	HF	3 ml	—	AP	FDA listed	—
Amiodarone Hydrochloride 150 mg/3mL 55150-0180-03	AuroMedics	10 vials	—	—	FDA listed	—
Amiodarone Hydrochloride 50 mg/mL 65219-0643-03	Fresenius	25 vials	—	AP	FDA listed	—
Amiodarone Hydrochloride 50 mg/mL 67457-0153-03	Mylan	10 vials	—	AP	FDA listed	—
Amiodarone Hydrochloride 50 mg/mL 70436-0232-50	Slate	1 vial	—	AP	FDA listed	—
Amiodarone Hydrochloride 50 mg/mL 70518-1231-01	REMEDYREPACK	25 vials	—	AP	FDA listed	—
Amiodarone Hydrochloride 50 mg/mL 71872-7000-01	Medical	1 vial	—	AP	FDA listed	—
Amiodarone Hydrochloride 50 mg/mL 71872-7034-01	Medical	1 vial	—	AP	FDA listed	—
Amiodarone Hydrochloride 150 mg/3mL 71872-7149-01	Medical	1 vial	—	—	FDA listed	—
Amiodarone Hydrochloride 50 mg/mL 71872-7163-01	Medical	1 vial	—	AP	FDA listed	—
Amiodarone Hydrochloride 50 mg/mL 71872-7354-01	Medical	1 vial	—	AP	FDA listed	—
Amiodarone Hydrochloride 50 mg/mL 72673-0071-10	Zhejiang	3 ml	—	AP	FDA listed	—
Amiodarone Hydrochloride 50 mg/mL 84549-0153-03	ProPharma	3 ml	—	AP	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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Oct 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2019

On the market since

Dec 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.

FDA Orange Book · refreshed Oct 3, 2026

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.

20.2 mg / 1 mL UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
100 mg / 1 mL UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.

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

Where does this data come from?

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

FDA label on DailyMed · label index refreshed Oct 3, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerHF Acquisition Co LLC, DBA HealthFirst

Application holderFRESENIUS KABI USA LLC

FDA applicationANDA075761 (ANDA)

Labeler code51662

First marketedDec 2019

Product typeHuman Prescription Drug

Portfolio333 products on file

More NDCs from HF Acquisition Co LLC, DBA HealthFirst labeler code 51662

🔎 All NDCs from HF Acquisition Co LLC, DBA HealthFirst

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel

🎯 Indications and Usage 117 words ▾

INDICATIONS & USAGE Amiodarone HCl injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Amiodarone HCl injection also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone HCl injection, patients may be transferred to oral amiodarone therapy (see DOSAGE & ADMINISTRATION ).

Amiodarone HCl injection should be used for acute treatment until the patient’s ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone HCl injection may be safely administered for longer periods if necessary.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE & ADMINISTRATION Amiodarone shows considerable interindividual variation in response. Thus, although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose as needed is essential. The recommended starting dose of amiodarone HCl injection is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen: After the first 24 hours, the maintenance infusion rate of 0.5 mg/min (720 mg/24 hours) should be continued utilizing a concentration of 1 to 6 mg/mL (Amiodarone HCl Injection concentrations greater than 2 mg/mL should be administered via a central venous catheter).

In the event of breakthrough episodes of VF or hemodynamically unstable VT, 150 mg supplemental infusions of amiodarone HCl injection mixed in 100 mL of D 5W may be administered. Such infusions should be administered over 10 minutes to minimize the potential for hypotension. The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.

The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. The initial infusion rate should not exceed 30 mg/min. Based on the experience from clinical studies of amiodarone HCl injection, a maintenance infusion of up to 0.5 mg/min can be cautiously continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function.

There has been limited experience in patients receiving amiodarone HCl injection for longer than 3 weeks. The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used.

Amiodarone HCl injection must be delivered by a volumetric infusion pump. Amiodarone HCl injection should, whenever possible, be administered through a central venous catheter dedicated to that purpose. An in-line filter should be used during administration.

Amiodarone HCl injection loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death (see PRECAUTIONS , Liver Enzyme Elevations). Amiodarone HCl injection concentrations greater than 3 mg/mL in D 5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, amiodarone HCl injection concentrations should not exceed 2 mg/mL unless a central venous catheter is used (see ADVERSE REACTIONS , Postmarketing Reports).

Amiodarone HCl injection infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D 5W. Use of evacuated glass containers for admixing amiodarone HCl injection is not recommended as incompatibility with a buffer in the container may cause precipitation. It is well known that amiodarone adsorbs to polyvinyl chloride (PVC) tubing and the clinical trial dose administration schedule was designed to account for this adsorption.

All of the clinical trials were conducted using PVC tubing and its use is therefore recommended. The concentrations and rates of infusion provided in DOSAGE & ADMINISTRATION reflect doses identified in these studies. Amiodarone HCl injection has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing).

The degree of leaching increases when infusing amiodarone HCl injection at higher concentrations and lower flow rates than provided in DOSAGE & ADMINISTRATION . In addition, polysorbate 80, a component of amiodarone HCl injection, is also known to leach DEHP from PVC (see DESCRIPTION ). Therefore, it is important that the recommendations in DOSAGE & ADMINISTRATION… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 43 words ▾

CONTRAINDICATIONS Amiodarone HCl injection is contraindicated in patients with known hypersensitivity to any of the components of amiodarone HCl injection, including iodine, or in patients with cardiogenic shock, marked sinus bradycardia, and second- or third-degree AV block unless a functioning pacemaker is available.

⚠️ Warnings ~3 min read ▾

WARNINGS Hypotension Hypotension is the most common adverse effect seen with Amiodarone HCl injection. In clinical trials, treatment-emergent, drug-related hypotension was reported as an adverse effect in 288 (16%) of 1836 patients treated with amiodarone HCl injection. Clinically significant hypotension during infusions was seen most often in the first several hours of treatment and was not dose-related, but appeared to be related to the rate of infusion.

Hypotension necessitating alterations in amiodarone HCl injection therapy was reported in 3% of patients, with permanent discontinuation required in less than 2% of patients. Hypotension should be treated initially by slowing the infusion; additional standard therapy may be needed, including the following: vasopressor drugs, positive inotropic agents, and volume expansion. The initial rate of infusion should be monitored closely and should not exceed that prescribed in DOSAGE & ADMINISTRATION .

In some cases, hypotension may be refractory resulting in fatal outcome (see ADVERSE REACTIONS , Post-marketing Reports). Bradycardia and AV Stock Drug-related bradycardia occurred in 90 (4.9%) of 1836 patients in clinical trials while they were receiving amiodarone HCl injection for life-threatening VT/VF; it was not dose-related. Bradycardia should be treated by slowing the infusion rate or discontinuing amiodarone HCl injection.

In some patients, inserting a pacemaker is required. Despite such measures, bradycardia was progressive and terminal in 1 patient during the controlled trials. Patients with a known predisposition to bradycardia or AV block should be treated with amiodarone HCl injection in a setting where a temporary pacemaker is available.

Liver Enzyme Elevations Elevations of blood hepatic enzyme values – alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) – are seen commonly in patients with immediately life-threatening VT/VF. Interpreting elevated AST activity can be difficult because the values may be elevated in patients who have had recent myocardial infarction, congestive heart failure, or multiple electrical defibrillations. Approximately 54% of patients receiving amiodarone HCl injection in clinical studies had baseline liver enzyme elevations, and 13% had clinically significant elevations.

In 81% of patients with both baseline and on-therapy data available, the liver enzyme elevations either improved during therapy or remained at baseline levels. Baseline abnormalities in hepatic enzymes are not a contraindication to treatment. Acute, centrolobular confluent hepatocellular necrosis leading to hepatic coma, acute renal failure, and death has been associated with the administration of amiodarone HCl injection at a much higher loading dose concentration and much faster rate of infusion than recommended in DOSAGE & ADMINISTRATION .

Therefore, the initial concentration and rate of infusion should be monitored closely and should not exceed that prescribed in DOSAGE & ADMINISTRATION (see DOSAGE & ADMINISTRATION ). In patients with life-threatening arrhythmias, the potential risk of hepatic injury should be weighed against the potential benefit of amiodarone HCl injection therapy, but patients receiving amiodarone HCl injection should be monitored carefully for evidence of progressive hepatic injury. Consideration should be given to reducing the rate of administration or withdrawing amiodarone HCl injection in such cases.

Proarrhythmia Like all antiarrhythmic agents, amiodarone HCl injection may cause a worsening of existing arrhythmias or precipitate a new arrhythmia. Proarrhythmia, primarily torsade de pointes (TdP), has been associated with prolongation by amiodarone HCl injection of the QTc interval to 500 ms or greater. Although QTc prolongation occurred frequently in patients receiving amiodarone HCl injection, torsade de pointes or new-onset VF occurred infrequently (less than 2%).

Patients should be monitored fo… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS In a total of 1836 patients in controlled and uncontrolled clinical trials, 14% of patients received amiodarone HCl injection for at least one week, 5% received it for at least 2 weeks, 2% received it for at least 3 weeks, and 1% received it for more than 3 weeks, without an increased incidence of severe adverse reactions. The mean duration of therapy in these studies was 5.6 days; median exposure was 3.7 days. The most important treatment-emergent adverse effects were hypotension, asystole/cardiac arrest/ electromechanical dissociation (EMD), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, VT, and AV block.

Overall, treatment was discontinued for about 9% of the patients because of adverse effects. The most common adverse effects leading to discontinuation of amiodarone HCl injection therapy were hypotension (1.6%), asystole/cardiac arrest/EMD (1.2%), VT (1.1%), and cardiogenic shock (1%). The following table lists the most common (incidence ≥ 2%) treatment-emergent adverse events during amiodarone HCl injection therapy considered at least possibly drug-related.

These data were collected in clinical trials involving 1836 patients with life-threatening VT/VF. Data from all assigned treatment groups are pooled because none of the adverse events appeared to be dose-related. SUMMARY TABULATION OF TREATMENT-EMERGENT DRUG-RELATED STUDY EVENTS IN PATIENTS RECEIVING AMIODARONE HCL INJECTION IN CONTROLLED AND OPEN-LABEL STUDIES (≥ 2% INCIDENCE) Other treatment-emergent possibly drug-related adverse events reported in less than 2% of patients receiving amiodarone HCl injection in controlled and uncontrolled studies included the following: abnormal kidney function, atrial fibrillation, diarrhea, increased ALT, increased AST, lung edema, nodal arrhythmia, prolonged QT interval, respiratory disorder, shock, sinus bradycardia, Stevens-Johnson syndrome, thrombocytopenia, VF, and vomiting.

Postmarketing Reports In postmarketing surveillance, hypotension (sometimes fatal), sinus arrest, anaphylactic/anaphylactoid reaction (including shock), angioedema, hepatitis, cholestatic hepatitis, cirrhosis, pancreatitis, renal impairment, renal insufficiency, acute renal failure, bronchospasm, possibly fatal respiratory disorders (including distress, failure, arrest, and ARDS), bronchiolitis obliterans organizing pneumonia (possibly fatal), fever, dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates and/or mass, pleuritis, pseudotumor cerebri, syndrome of inappropriate antidiuretic hormone secretion (SIADH), thyroid nodules/thyroid cancer, toxic epidermal necrolysis (sometimes fatal), erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, skin cancer, vasculitis, pruritus, hemolytic anemia, aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis, granuloma, myopathy, muscle weakness, rhabdomyolysis, hallucination, confusional state, disorientation, delirium, epididymitis, and impotence also have been reported with amiodarone therapy.

Also, in patients receiving recommended dosages of amiodarone HCl injection, there have been postmarketing reports of the following injection site reactions: pain, erythema, edema, pigment changes, venous thrombosis, phlebitis, thrombophlebitis, cellulitis, necrosis, and skin sloughing (see DOSAGE & ADMINISTRATION ). ADVERSE

🆘 Overdosage 71 words ▾

OVERDOSAGE There have been cases, some fatal, of amiodarone overdose. Effects of an inadvertent overdose of amiodarone HCl injection include hypotension, cardiogenic shock, bradycardia, AV block, and hepatotoxicity. Hypotension and cardiogenic shock should be treated by slowing the infusion rate or with standard therapy: vasopressor drugs, positive inotropic agents, and volume expansion.

Bradycardia and AV block may require temporary pacing. Hepatic enzyme concentrations should be monitored closely. Amiodarone is not dialyzable.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanisms of Action Amiodarone is generally considered a class III antiarrhythmic drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes. Like class I drugs, amiodarone blocks sodium channels at rapid pacing frequencies, and like class II drugs, it exerts a noncompetitive antisympathetic action. One of its main effects, with prolonged administration, is to lengthen the cardiac action potential, a class III effect.

The negative chronotropic effect of amiodarone in nodal tissues is similar to the effect of class IV drugs. In addition to blocking sodium channels, amiodarone blocks myocardial potassium channels, which contributes to slowing of conduction and prolongation of refractoriness. The antisympathetic action and the block of calcium and potassium channels are responsible for the negative dromotropic effects on the sinus node and for the slowing of conduction and prolongation of refractoriness in the atrioventricular (AV) node.

Its vasodilatory action can decrease cardiac workload and consequently myocardial oxygen consumption. Amiodarone HCl Injection administration prolongs intranodal conduction (Atrial-His, AH) and refractoriness of the atrioventricular node (ERP AVN), but has little or no effect on sinus cycle length (SCL), refractoriness of the right atrium and right ventricle (ERP RA and ERP RV), repolarization (QTc), intraventricular conduction (QRS), and infranodal conduction (His-ventricular, HV). A comparison of the electrophysiologic effects of amiodarone HCl injection and oral amiodarone is shown in the table below.

EFFECTS OF INTRAVENOUS AND ORAL AMIODARONE ON ELECTROPHYSIOLOGIC PARAMETERS ⇔No change At higher doses (>10 mg/kg) of amiodarone HCl injection, prolongation of the ERP RV and modest prolongation of the QRS have been seen. These differences between oral and IV administration suggest that the initial acute effects of amiodarone HCl injection may be predominantly focused on the AV node, causing an intranodal conduction delay and increased nodal refractoriness due to slow channel blockade (class IV activity) and noncompetitive adrenergic antagonism (class II activity).

Pharmacokinetics and Metabolism Amiodarone exhibits complex disposition characteristics after intravenous administration. Peak serum concentrations after single 5 mg/kg 15-minute intravenous infusions in healthy subjects range between 5 and 41 mg/L. Peak concentrations after 10-minute infusions of 150 mg amiodarone HCl injection in patients with ventricular fibrillation (VF) or hemodynamically unstable ventricular tachycardia (VT) range between 7 and 26 mg/L.

Due to rapid distribution, serum concentrations decline to 10% of peak values within 30 to 45 minutes after the end of the infusion. In clinical trials, after 48 hours of continued infusions (125, 500 or 1000 mg/day) plus supplemental (150 mg) infusions (for recurrent arrhythmias), amiodarone mean serum concentrations between 0.7 to 1.4 mg/L were observed (n=260). N-desethylamiodarone (DEA) is the major active metabolite of amiodarone in humans.

DEA serum concentrations above 0.05 mg/L are not usually seen until after several days of continuous infusion but with prolonged therapy reach approximately the same concentration as amiodarone. Amiodarone is metabolized to desethylamiodarone by the cytochrome P450 (CYP450) enzyme group, specifically cytochrome P450 3A4 (CYP3A4) and CYP2C8. The CYP3A4 isoenzyme is present in both the liver and intestines.

The highly variable systemic availability of oral amiodarone may be attributed potentially to large interindividual variability in CYP3A4 activity. Amiodarone is eliminated primarily by hepatic metabolism and biliary excretion and there is negligible excretion of amiodarone or DEA in urine. Neither amiodarone nor DEA is dialyzable.

Amiodarone and DEA cross the placenta and both appear in breast milk. No data are available on the activity of DEA in humans, but in animals, it has si… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 87 words ▾

HOW SUPPLIED AMIODARONE HCI INJECTION is supplied in the following dosage forms. NDC 51662-1363-1 AMIODARONE HCI INJECTION 150 mg/3 mL (50 mg/mL) 3 mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Amiodarone HCl Injection is supplied as: Vial stoppers do not contain natural rubber latex. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light and excessive heat. Use carton to protect contents from light until used. HOW SUPPLIED

📋 Description 122 words ▾

DESCRIPTION Amiodarone Hydrochloride Injection, for intravenous use, contains amiodarone HCl, a class III antiarrhythmic drug. Amiodarone HCl is (2-butyl-3-benzofuranyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl] methanone hydrochloride. Amiodarone HCl has the following structural formula: C 25H 29I 2NO 3•HCl M.W.

681.78 Amiodarone HCl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It contains 37.3% iodine by weight. Amiodarone HCl Injection is a sterile clear, pale-yellow micellular solution visually free from particulates.

Each mL of the Amiodarone HCl Injection formulation contains 50 mg of amiodarone HCl, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone HCl injection contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) (see DOSAGE & ADMINISTRATION ). STRUCTURE

⚠️ Precautions ~3 min read ▾

PRECAUTIONS Amiodarone HCl injection should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits of amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment. Thyroid Abnormalities Amiodarone inhibits peripheral conversion of thyroxine (T 4) to triiodothyronine (T 3) and may cause increased thyroxine levels, decreased T 3 levels, and increased levels of inactive reverse T 3 (rT 3) in clinically euthyroid patients.

It is also a potential source of large amounts of inorganic iodine. Because of its release of inorganic iodine, or perhaps for other reasons, amiodarone can cause either hypothyroidism or hyperthyroidism. Thyroid function should be monitored prior to treatment and periodically thereafter, particularly in elderly patients, and in any patient with a history of thyroid nodules, goiter, or other thyroid dysfunction.

Because of the slow elimination of amiodarone and its metabolites, high plasma iodide levels, altered thyroid function, and abnormal thyroid-function tests may persist for several weeks or even months following amiodarone withdrawal. Hypothyroidism has been reported in 2 to 4% of patients in most series, but in 8 to 10% in some series. This condition may be identified by relevant clinical symptoms and particularly by elevated serum TSH levels.

In some clinically hypothyroid amiodarone-treated patients, free thyroxine index values may be normal. Hypothyroidism is best managed by amiodarone dose reduction and/or thyroid hormone supplement. However, therapy must be individualized, and it may be necessary to discontinue amiodarone tablets in some patients.

Hyperthyroidism occurs in about 2% of patients receiving amiodarone, but the incidence may be higher among patients with prior inadequate dietary iodine intake. Amiodarone-induced hyperthyroidism usually poses a greater hazard to the patient than hypothyroidism because of the possibility of thyrotoxicosis and/or arrhythmia breakthrough or aggravation, all of which may result in death. There have been reports of death associated with amiodarone-induced thyrotoxicosis.

IF ANY NEW SIGNS OF ARRHYTHMIA APPEAR, THE POSSIBILITY OF HYPERTHYROIDISM SHOULD BE CONSIDERED. Hyperthyroidism is best identified by relevant clinical symptoms and signs, accompanied usually by abnormally elevated levels of serum T 3 RIA, and further elevations of serum T 4, and a subnormal serum TSH level (using a sufficiently sensitive TSH assay). The finding of a flat TSH response to TRH is confirmatory of hyperthyroidism and may be sought in equivocal cases.

Since arrhythmia breakthroughs may accompany amiodarone-induced hyperthyroidism, aggressive medical treatment is indicated, including, if possible, dose reduction or withdrawal of amiodarone. The institution of antithyroid drugs, β-adrenergic blockers and/or temporary corticosteroid therapy may be necessary. The action of antithyroid drugs may be especially delayed in amiodarone-induced thyrotoxicosis because of substantial quantities of preformed thyroid hormones stored in the gland.

There have been reports of death associated with amiodarone-induced thyrotoxicosis. Radioactive iodine therapy is contraindicated because of the low radioiodine uptake associated with amiodarone-induced hyperthyroidism. Amiodarone-induced hyperthyroidism may be followed by a transient period of hypothyroidism (see WARNINGS, Thyrotoxicosis).

When aggressive treatment of amiodarone-induced thyrotoxicosis has failed or amiodarone cannot be discontinued because it is the only drug effective against the resistant arrhythmia, surgical management may be an option. Experience with thyroidectomy as a treatment for amiodarone-induced thyrotoxicosis is limited, and this form of therapy could induce thyroid storm. Therefore, surgical and anesthetic management require careful planning.

There have be… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 15 words ▾

PRINCIPAL DISPLAY PANEL - VIAL LABEL VIAL

PRINCIPAL DISPLAY PANEL - SERIALIZED LABELING SERIALIZED LABELING

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

contraindication: A situation in which a medicine should not be used because the risk is considered too high.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anaphylactoid reaction: A severe reaction that looks like a serious allergic reaction but is not caused by the usual allergy antibodies.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

aplastic anemia: A serious condition where the bone marrow stops making enough new blood cells.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

atrial fibrillation: An irregular, often fast heart rhythm coming from the heart's upper chambers, which can raise the risk of blood clots.

AV block: A slowing or blocking of the electrical signals traveling between the heart's upper and lower chambers, which can slow the heartbeat.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

cellulitis: A spreading bacterial infection of the skin and the tissue just beneath it.

cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

gamma-glutamyl transferase: A liver enzyme measured in blood; higher levels can signal the liver or bile ducts are irritated.

GGT: A liver enzyme measured in blood; higher levels can signal the liver or bile ducts are irritated.

hallucination: Seeing, hearing, feeling, or smelling something that is not actually there.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hemoptysis: Coughing up blood or bloody mucus from the lungs or airways.

hepatic metabolism: The breakdown of a medicine by the liver into other substances the body can use or remove.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hyperthyroidism: A condition where the thyroid gland makes too much thyroid hormone, which can speed the body up.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

hypothyroidism: A condition where the thyroid gland makes too little thyroid hormone, which can slow the body down.

hypoxia: A condition in which the body's tissues do not get enough oxygen.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

loading dose: A larger dose given at the start to quickly build the medicine up to an effective level in the body.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

myopathy: A disease of the muscles that can make them weak, painful, or tender.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

pancytopenia: A low level of all three main blood cell types at once: red cells, white cells, and platelets.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

postmarketing surveillance: Tracking of a medicine's safety after it is approved and being used by the general public.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

pruritus: Itching of the skin.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

refractory: Describing a disease that does not respond to, or improve with, treatment.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

rhabdomyolysis: A serious condition where damaged muscle breaks down and releases material into the blood that can harm the kidneys.

SIADH: Syndrome of inappropriate antidiuretic hormone: the body makes too much of a water-holding hormone, which lowers the level of sodium (salt) in the blood.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

TSH: Thyroid-stimulating hormone, a hormone measured by a blood test to check how well the thyroid gland is working.

ventricular fibrillation: A life-threatening, chaotic rhythm in the heart's lower chambers that stops the heart from pumping blood effectively.

wheezing: A high-pitched whistling sound made while breathing, usually when the airways are narrowed.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

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Is the NDC printed on the package the same as the 11-digit billing NDC?

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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 HF Acquisition Co LLC, DBA HealthFirst. Listing status can change — the directory data on this page refreshes weekly.

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Related NDC lookups

🧪 All Amiodarone Hci NDCsSame ingredient 🏭 All HF labeler NDCsLabeler code 51662 📚 All Antiarrhythmic NDCsDrug class

AMIODARONE HCI 50 mg/mL Injection, Solution, 3 mL — NDC 51662-1363-1 (Billing 51662-1363-01)

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