Linezolid Tablet
Product Images NDC 85766-075

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Linezolid (NDC 85766-075). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sportpharm Llc, 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

Label (Label)

Packaging labels for Linezolid Tablets, USP 600 mg, oral tablet. The labels show two package sizes: quantity 20 with NDC 85766-075-20 and quantity 30 with NDC 85766-075-30. The product is relabeled for Sportpharm and manufactured for Rising Pharma Holdings, Inc. The labels include storage information, drug status (Rx), and handling cautions.*

FDA Label Image

Linezolid Tab-2.jpg (Linezolid Tab 2)

A data table listing adverse reactions with comparative incidence rates for Linezolid 400 mg every 12 hours and Clarithromycin 250 mg every 12 hours in uncomplicated skin and skin structure infections, alongside Linezolid 600 mg every 12 hours and other comparators for all other indications. The table includes common side effects such as headache, diarrhea, nausea, vomiting, dizziness, rash, and others, with numerical percentages for each group.*

FDA Label Image

Linezolid-graph.jpg (Linezolid Graph)

A line graph depicting plasma concentration of Linezolid over 12 hours after a 600 mg oral dose given every 12 hours. The x-axis shows time in hours post-dose, and the y-axis shows Linezolid plasma concentration in micrograms per milliliter with error bars representing variability at each time point.*

FDA Label Image

Linezolid-structure.jpg (Linezolid Structure)

Chemical structure of Linezolid, showing the molecular arrangement including a morpholine ring, fluorophenyl group, oxazolidinone core, and an acetamido side chain.*

FDA Label Image

Linezolid-tab-10.jpg (Linezolid Tab 10)

A pharmacokinetic data table comparing Linezolid and its metabolites A and B in healthy subjects and patients with moderate and severe renal impairment. Parameters include AUC and half-life (t1/2) with values for different renal clearance ranges (CLCR). Metabolite B is noted as the major metabolite of Linezolid.*

FDA Label Image

Linezolid-tab-11.jpg (Linezolid Tab 11)

A data table presenting pharmacokinetic parameters of Linezolid and its metabolites in ESRD subjects between hemodialysis sessions. It lists AUC (mcg h/mL) and half-life (hours) after the last dose for Linezolid, Metabolite A, and Metabolite B, noting Metabolite B as the major metabolite of Linezolid.*

FDA Label Image

Linezolid-tab-12.jpg (Linezolid Tab 12)

A data table comparing the cure rates of Linezolid and Vancomycin against three pathogens: Staphylococcus aureus, Methicillin-resistant Staphylococcus aureus, and Streptococcus pneumoniae. The table includes counts and percentages of cured cases for each treatment and pathogen.*

FDA Label Image

Linezolid-tab-13.jpg (Linezolid Tab 13)

A data table comparing cure rates of Linezolid versus Oxacillin/Dicloxacillin for various pathogens, including Staphylococcus aureus, Methicillin-resistant S. aureus, Streptococcus agalactiae, and Streptococcus pyogenes. The table lists the number and percentage of cured cases for each treatment.*

FDA Label Image

Linezolid-tab-14.jpg (Linezolid Tab 14)

A data table showing cure rates for three pathogens: Staphylococcus aureus, Methicillin-resistant S. aureus, and Streptococcus agalactiae. The table compares the number and percentage cured with Linezolid versus a Comparator treatment.*

FDA Label Image

Linezolid-tab-15.jpg (Linezolid Tab 15)

A data table comparing the cure rates for various infection sources at two linezolid dosing regimens: 600 mg every 12 hours and 200 mg every 12 hours. It shows counts and percentages of patients cured from infection sites including skin, urinary tract, pneumonia, and bacteremia, indicating higher cure rates generally with the 600 mg dose.*

FDA Label Image

Linezolid-tab-16.jpg (Linezolid Tab 16)

A data table comparing clinical population outcomes for Linezolid and Vancomycin across ITT, MITT, and Clinically Evaluable groups. It presents patient numbers and percentages for any diagnosis, complicated skin and skin structure infections, and nosocomial pneumonia within each treatment and population category.*

FDA Label Image

Linezolid-tab-17.jpg (Linezolid Tab 17)

A data table comparing microbiological evaluability of Linezolid and Vancomycin against several pathogens: Vancomycin-resistant Enterococcus faecium, Staphylococcus aureus, Methicillin-resistant Staphylococcus aureus (MRSA), and Streptococcus pyogenes. The table presents numbers of cases with positive microbiological evaluation and the corresponding percentages for each antibiotic.*

FDA Label Image

Linezolid-tab-3.jpg (Linezolid Tab 3)

A table showing adverse reactions incidence percentages for Linezolid compared to Cefadroxil and Vancomycin in treating uncomplicated skin and skin structure infections and other indications. The table lists reactions such as diarrhea, vomiting, headache, anemia, thrombocytopenia, nausea, and others across different patient counts for each drug group.*

FDA Label Image

Linezolid-tab-4.jpg (Linezolid Tab 4)

A data table presenting laboratory assay results comparing hematologic parameters including hemoglobin, platelet count, white blood cell count (WBC), and neutrophils in patients treated with Linezolid or Clarithromycin for uncomplicated skin and skin structure infections, and Linezolid or other comparators for all other indications. The table details specific dosages and measurement units for these parameters.*

FDA Label Image

Linezolid-tab-5.jpg (Linezolid Tab 5)

A data table titled 'Laboratory Assay' comparing laboratory values for Linezolid 400 mg and Clarithromycin 250 mg every 12 hours in uncomplicated skin and skin structure infections, and Linezolid 600 mg every 12 hours against all other comparators in all other indications. The table lists assays including AST, ALT, LDH, alkaline phosphatase, lipase, amylase, total bilirubin, BUN, and creatinine with corresponding numeric assay values.*

FDA Label Image

Linezolid-tab-6.jpg (Linezolid Tab 6)

A data table presenting laboratory assay values comparing Linezolid and other antibiotics. It includes hemoglobin, platelet count, white blood cell count (WBC), and neutrophil values for patients with uncomplicated skin and skin structure infections and all other indications, listing Linezolid, Cefadroxil, and Vancomycin data side by side.*

FDA Label Image

Linezolid-tab-7.jpg (Linezolid Tab 7)

A data table comparing laboratory assay results for Linezolid, Cefadroxil, and Vancomycin. It includes values for ALT, Lipase, Amylase, Total bilirubin, and Creatinine under conditions of uncomplicated skin and skin structure infections versus all other indications.*

FDA Label Image

Linezolid-tab-8.jpg (Linezolid Tab 8)

A data table presenting pharmacokinetic parameters of Linezolid at various doses and forms, including 400 mg tablet, 600 mg tablet, 600 mg IV injection, and 600 mg oral suspension. The table lists maximum and minimum plasma concentrations (Cmax, Cmin), time to maximum concentration (Tmax), area under the curve (AUC), half-life (t1/2), and systemic clearance (CL), with values for single and multiple dosing.*

FDA Label Image

Linezolid-tab-9.jpg (Linezolid Tab 9)

A pharmacokinetic data table comparing Linezolid plasma concentration, volume of distribution, area under the curve, half-life, and clearance across various age groups, including neonatal, infant, pediatric, adolescent, and adult subjects. The table presents mean values with variability measures for each parameter by age group.*

* 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.