Rocuronium Bromide Injection, Solution
Product Images NDC 51662-1354

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Rocuronium Bromide (NDC 51662-1354). 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

5 mL Vial Label (5 mL Vial Label)

Label for Rocuronium Bromide Injection 10 mg/mL in a 5 mL multiple dose vial. The label indicates intravenous use only and prescription status. Manufacturer is Hospira, Inc. with location in Lake Forest, IL. The label contains warnings about respiratory depression and mentions it requires facilities for artificial respiration.*

FDA Label Image

C1 (Clinical Pharm 1)

A data table presenting outcomes of Rocuronium Bromide doses administered over 5 seconds in different patient groups. It shows dose in mg/kg, percent of patients with excellent or good intubating conditions, and time to completion of intubation in minutes for adults aged 18 to 64 years, infants 3 months to 1 year, and pediatric patients 1 to 12 years.*

FDA Label Image

C2 (Clinical Pharm 2)

A data table showing rocuronium bromide dosage (mg/kg) administered over 5 seconds and corresponding values for time to ≥80% block, time to maximum block, and clinical duration (all in minutes). Data are categorized by age groups: adults 18 to 64 years, geriatrics ≥65 years, infants 3 months to 1 year, and pediatric 1 to 12 years, with sample sizes noted for each dosage.*

FDA Label Image

C10 (Clinical Pharma 10)

A pharmacokinetic data table showing PK parameters for Rocuronium Bromide across different patient age ranges, from birth to 17 years. The table lists clearance (CL), volume of distribution, and half-life (t1/2 β) values with standard deviations. Age groups include birth to under 28 days, 28 days to 3 months, 3 months to 2 years, 2 to 11 years, and 11 to 17 years.*

FDA Label Image

C3 (Clinical Pharma 3)

A data table presenting the time to maximum block and time to reappearance T3 in minutes for Rocuronium Bromide intravenous injection at various doses (0.45, 0.6, 1 mg/kg) administered over 5 seconds, across different pediatric age groups from neonates to adolescents.*

FDA Label Image

C4 (Clinical Pharma 4)

A box plot chart titled 'Time to 80% or greater Block vs. Initial Dose of Rocuronium Bromide by Age Group' showing median, 25th and 75th percentile, and individual values. The x-axis categorizes initial doses in mg/kg across three age groups: 18-64 years, 65 years and older, and 1-12 years. The y-axis measures time in minutes, ranging from 0 to 9. The chart illustrates variation in block onset time relative to dosage and age group.*

FDA Label Image

C5 (Clinical Pharma 5)

A box plot chart titled 'Duration of Clinical Effect vs. Initial Dose of Rocuronium Bromide by Age Group' showing duration in minutes on the y-axis and dosage in mg/kg on the x-axis. The graph compares clinical effect duration across four age groups (18-64 yrs, >=65 yrs, 3 mo-1 yr, 1-12 yrs) with various doses, displaying median, 25th and 75th percentiles, and individual values.*

FDA Label Image

C6 (Clinical Pharma 6)

A line graph titled 'Duration of Clinical Effect vs. Number of Rocuronium Bromide Maintenance Doses, by Dose,' showing clinical effect duration in minutes on the y-axis and dose number on the x-axis. The graph compares two dosage groups of Rocuronium Bromide: 0.15 mg/kg and 0.1 mg/kg, with sample sizes of 13 and 29 respectively, illustrating changes in duration over up to five doses.*

FDA Label Image

C7 (Clinical Pharma 7)

A data table displaying pharmacokinetic (PK) parameters for ROCURONIUM BROMIDE injection solution comparing adults (ages 27 to 58 years) and geriatrics (65 years and older). Parameters include clearance (L/kg/hr), volume of distribution at steady state (L/kg), and elimination half-life (hours), with values and standard deviations shown for each age group.*

FDA Label Image

C8 (Clinical Pharma 8)

A data table presenting pharmacokinetic parameters of rocuronium bromide in different patient groups: normal renal and hepatic function, renal transplant patients, and hepatic dysfunction patients. Parameters include clearance (L/kg/hr), volume of distribution at steady state (L/kg), and elimination half-life (hr). Values with standard deviations are shown for each group.*

FDA Label Image

C9 (Clinical Pharma 9)

A data table showing pharmacokinetic parameters of rocuronium bromide by patient age ranges (3 to <12 months, 1 to <3 years, 3 to <8 years). Parameters include Clearance (L/kg/hr), Volume of Distribution at Steady State (L/kg), and t1/2 β Elimination (hr), with values and standard deviations for each age group.*

FDA Label Image

D 1 (Dosage And Administration 1)

A data table showing infusion delivery rates in mL/hr for ROCURONIUM BROMIDE injection solution based on patient weight in kilograms and pounds, and drug delivery rate in mcg/kg/min. The table provides corresponding infusion rates for weights from 10 to 100 kg and drug delivery rates from 4 to 16 mcg/kg/min.*

FDA Label Image

D2 (Dosage And Administration 2)

Data table showing infusion delivery rates (mL/hr) of Rocuronium Bromide Injection, Solution, 10 mg/mL, across various drug delivery rates (mcg/kg/min) and patient weights in kilograms and pounds. The table cross-references patient weights from 10 kg (22 lbs) to 100 kg (220 lbs) with drug delivery rates from 4 to 16 mcg/kg/min.*

FDA Label Image

D3 (Dosage And Administration 3)

A dosing reference table for rocuronium bromide infusion showing patient weight in kilograms and pounds, drug delivery rates in mcg/kg/min, and corresponding infusion delivery rates in mL/hr. The table lists weights from 10 to 100 kg and drug delivery rates from 4 to 16 mcg/kg/min with calculated infusion rates.*

FDA Label Image

Highlight Table (Highlights)

A data table showing sections of the ROCURONIUM BROMIDE prescribing information with titles and their respective revision dates, including dosing and administration, warnings, and precautions. The table has alternating shaded rows and includes hyperlinks for each section title.*

FDA Label Image

Logo (Logo)

FDA Label Image

Serialized Label (Serialized 5 mL Vial Label)

Rocuronium Bromide injection, solution, 10 mg/mL in a 5 mL multiple-dose vial with a yellow cap labeled "Paralyzing Agent." The vial has a bright orange label and a barcode label with distribution information by HF Acquisition Co LLC, DBA HealthFirst.*

FDA Label Image

Serialized Vial Labeling Rocuronium Update

Rocuronium Bromide injection, solution, 10 mg/mL in a 5 mL multiple dose vial. The vial has a yellow cap with 'PARALYZING AGENT' printed on it. The label shows the product name and concentration, specifies intravenous use only, and includes use restrictions as Rx only. The product is distributed by HF Acquisition Co LLC, DBA HealthFirst.*

FDA Label Image

Structure (Structure)

Chemical structure of rocuronium bromide showing its molecular framework with labeled functional groups including an ammonium ion and a bromide ion.*

FDA Label Image

Vial Label Update

Label for Rocuronium Bromide Injection, solution for intravenous use, strength 10 mg/mL (50 mg/5 mL). The label includes dosage information, warnings indicating it is a paralyzing agent for intravenous use only, and a barcode. Labeler is HF Acquisition Co LLC, DBA HealthFirst, with partial branding elements from Pfizer visible.*

* 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.