Amiodarone Hydrochloride Injection, Solution
Product Images NDC 51662-1358

10 FDA label images from Hf Acquisition Co Llc, Dba Healthfirst · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Amiodarone Hydrochloride (NDC 51662-1358). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hf Acquisition Co Llc, Dba Healthfirst, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Carton (18 mL Carton)

Carton (18 mL Carton)
Packaging label for Amiodarone Hydrochloride Injection 900 mg per 18 mL (50 mg/mL) solution for intravenous use. The label includes manufacturer information for Mylan Institutional LLC and states the vial is single-use, Rx only, and must be diluted. Storage instructions and ingredients per mL are also provided. The design features purple, blue, and white colors with a barcode and lot/expiration date fields.*
FDA Label Image

Table 5 (Adverse 5)

Table 5 (Adverse 5)
A data table summarizing adverse events by study type and total for Amiodarone Hydrochloride. It lists events such as fever, bradycardia, congestive heart failure, heart arrest, hypotension, ventricular tachycardia, abnormal liver function tests, and nausea, providing counts and percentages for controlled studies, open-label studies, and combined totals.*
FDA Label Image

Table 6 (Clinical 6)

Table 6 (Clinical 6)
A data table comparing the effects of intravenous and oral formulations of amiodarone hydrochloride on various cardiac parameters including SCL, QRS, QTc, AH, HV, ERP RA, ERP RV, and ERP AVN with arrows indicating the direction or change for each parameter.*
FDA Label Image

Table 1 (Dosage 1)

Table 1 (Dosage 1)
Table showing infusion instructions for amiodarone hydrochloride injection, including loading infusions with a first rapid and a followed slow phase, and a maintenance infusion with specified dosage amounts, infusion times, and solution concentrations.*
FDA Label Image

Table 2 (Dosage 2)

Table 2 (Dosage 2)
A data table presenting physical compatibility information for Amiodarone Hydrochloride injection solution with 5% Dextrose in Water (D5W) at concentrations between 1.0 to 6.0 mg/mL in different containers: PVC and Polyolefin/Glass. It includes comments on amiodarone loss at specified times and room temperature conditions.*
FDA Label Image

Table 3 (Dosage 3)

Table 3 (Dosage 3)
A data table listing drugs alongside their compatible vehicles and corresponding amiodarone concentrations. It includes drugs such as Aminophylline, Amoxicillin Sodium-Clavulanic Acid, and others, specifying vehicles like D5W, NS, and unknown, with amiodarone concentrations ranging from 1.5 mg/mL to 15 mg/mL or marked as '--' where not available.*
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Table 4 (Dosage 4)

Table 4 (Dosage 4)
A table showing the initial daily dose of oral amiodarone based on the duration of amiodarone infusion. It lists doses for infusion durations of less than 1 week, 1 to 3 weeks, and more than 3 weeks, with corresponding doses ranging from 400 mg to 1600 mg.*
FDA Label Image

Serialized Carton (Serialized Carton)

Serialized Carton (Serialized Carton)
Box of Amiodarone Hydrochloride Injection, USP, 900 mg/18 mL (50 mg/mL) manufactured for Mylan Institutional LLC. The label indicates intravenous use only and that the product must be diluted. The packaging also displays the Mylan logo and states it is a single-dose vial for Rx only.*
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Structure (Structure)

Structure (Structure)
Chemical structure of Amiodarone hydrochloride, depicting its molecular bonds and functional groups including iodine atoms, ethyl groups, and an amine moiety with a hydrochloride salt.*
FDA Label Image

Vial (Vial)

Vial (Vial)
Amiodarone HCl Injection vial containing 900 mg per 18 mL (50 mg/mL) solution for intravenous use. The label indicates the product must be diluted before use. It is marked as a single-use vial, prescription only, and is manufactured by Mylan. The vial is clear with a blue-gray cap.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.