Azithromycin
Product Images NDC 61919-382

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Azithromycin (NDC 61919-382). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Direct Rx, 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

Image Description (Label)

Label for AZITHROMYCIN ORAL SUSP 200mg/5mL in a 30 mL bottle by DIRECT RX, generic for ZITHROMAX. The label includes dosing information, lot number, and expiration date, with instructions to shake well before use. The label emphasizes the 200mg/5mL strength and 30 mL volume size.*

FDA Label Image

Image Description (Module)

Chemical structure diagram of azithromycin showing its molecular framework with multiple rings, hydroxyl groups, and methyl substitutions. The image illustrates the detailed arrangement of atoms and bonds characteristic of the antibiotic azithromycin.*

FDA Label Image

Image Description (Table 1)

A table presenting pharmacokinetic parameters of azithromycin for 12 subjects, showing mean values on Day 1 and Day 5. Parameters include maximum concentration (Cmax), time to maximum concentration (Tmax), area under the curve from 0 to 24 hours (AUC0-24), minimum concentration (Cmin), and urinary excretion percentage of the dose. A footnote indicates bioequivalence information between 250 mg tablets and capsules.*

FDA Label Image

Image Description (Table 2)

A data table comparing pharmacokinetic parameters of Azithromycin for 3 Day and 5 Day Regimens. It lists mean (SD) values of serum Cmax (mcg/mL), serum AUC0-∞ (mcg·hr/mL), and serum half-life (hours) for Day 1 and Day 3 or Day 5, respectively, with a note on total AUC for each regimen.*

FDA Label Image

Image Description (Table 4)

A data table comparing pharmacokinetic parameters of AZITHROMYCIN for two regimens: a 3-day regimen (20 mg/kg for 3 days) and a 5-day regimen (12 mg/kg for 5 days). It includes mean and standard deviation for Cmax, Tmax, and AUC0-24 values, along with sample sizes for each group.*

FDA Label Image

Image Description (Table 5)

A data table titled 'Drug Interactions: Pharmacokinetic Parameters for Coadministered Drugs in the Presence of Azithromycin.' It lists coadministered drugs, their doses, azithromycin doses, sample sizes, and the ratio of pharmacokinetic parameters (Cmax and AUC) with and without azithromycin, including confidence intervals. Drugs include Atorvastatin, Carbamazepine, Cetirizine, Didanosine, Efavirenz, Fluconazole, Indinavir, Midazolam, Nelfinavir, and Rifabutin.*

FDA Label Image

Image Description (Table 6)

A data table presenting drug dosage regimens and concentrations, including medications like Sildenafil, Theophylline, Triazolam, Trimethoprim/Sulfamethoxazole, and Zidovudine. It lists dosages, administration routes, durations, number of subjects, and mean concentration values with confidence intervals, including footnotes about specific concentration details and confidence interval reporting.*

FDA Label Image

Image Description (Table 7)

A table presenting drug interactions with azithromycin, detailing pharmacokinetic parameters when coadministered with other drugs. It lists coadministered drugs, their doses, azithromycin doses, sample sizes, and ratios of mean Cmax and mean AUC comparing presence and absence of coadministered drugs, including drugs like efavirenz, fluconazole, nelfinavir, and rifabutin.*

FDA Label Image

Image Description (Table 8)

A data table titled 'Susceptibility Test Interpretive Criteria for Azithromycin' showing Minimum Inhibitory Concentrations (mcg/mL) and Disk Diffusion zone diameters (mm) for various pathogens, including Haemophilus influenzae, Staphylococcus aureus, and Streptococci including S. pneumoniae. It provides breakpoints for susceptible, intermediate, and resistant categories with an explanatory note on testing conditions and interpretive limitations for Haemophilus influenzae.*

FDA Label Image

Image Description (Table 9)

A data table titled 'Acceptable Quality Control Ranges for Azithromycin' listing QC strains with corresponding Minimum Inhibitory Concentrations (mcg/mL) and Disk Diffusion zone diameters (mm). It includes strains Haemophilus influenzae ATCC 49247, Staphylococcus aureus ATCC 29213 and 25923, and Streptococcus pneumoniae ATCC 49619, with respective ranges for inhibition concentrations and disk diffusion zones.*

FDA Label Image

Image Description (Table)

A data table titled 'Azithromycin Concentrations Following a 500 mg Dose (Two 250 mg Capsules) in Adults' showing concentrations of azithromycin in various tissues or fluids over different times after dosing. Columns include tissue/fluid type, time after dose, tissue or fluid concentration, corresponding plasma or serum level, and tissue/plasma serum ratio.*

* 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.