Glycerol Phenylbutyrate Liquid
Product Images NDC 49884-264

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Glycerol Phenylbutyrate (NDC 49884-264). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Par Health Usa, 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

Structural Formula (Glycerol Phenylbutyrate Oral Liquid 1)

Chemical structure diagram of the active ingredient Glycerol Phenylbutyrate. The image depicts the molecular arrangement with phenyl groups and ester linkages characteristic of the compound.*

FDA Label Image

Figure 1 (Glycerol Phenylbutyrate Oral Liquid 2)

A biochemical pathway diagram illustrating the metabolism of Glycerol Phenylbutyrate into phenylacetylglutamine, which is then excreted in urine. The pathway shows glutamate and phenylbutyric acid as intermediates, involving enzymatic steps such as ester hydrolysis, pancreatic lipases, and beta oxidation, alongside the conversion of glutamate to glutamine with the incorporation of ammonium ions.*

FDA Label Image

Figure 2 (Glycerol Phenylbutyrate Oral Liquid 3)

A line graph comparing mean normalized blood ammonia levels (µmol/L) over time for Glycerol Phenylbutyrate and Sodium Phenylbutyrate. The x-axis shows time points from 0-hour (fasting) through 24-hour (fasting), while the y-axis indicates blood ammonia levels with error bars representing standard error. Glycerol Phenylbutyrate is plotted with a solid line and square markers; Sodium Phenylbutyrate is plotted with a dashed line and triangle markers.*

FDA Label Image

Figure 3 (Glycerol Phenylbutyrate Oral Liquid 4)

A line graph depicting the mean (SE) normalized blood ammonia levels (µmol/L) over a 12-month period during fasting conditions for glycerol phenylbutyrate. The x-axis represents monthly fasting time points from baseline to month 12, and the y-axis shows ammonia levels ranging from 0 to 70 µmol/L. Data points are connected with a line, each marked with a square symbol and error bars.*

FDA Label Image

Figure 4 (Glycerol Phenylbutyrate Oral Liquid 5)

A line graph comparing mean normalized blood ammonia levels (µmol/L) over time between Glycerol Phenylbutyrate and Sodium Phenylbutyrate. Time points are at 0-hour (fasting), 8-hour, 12-hour, and 24-hour (fasting). Glycerol Phenylbutyrate is represented by a solid line with square markers; Sodium Phenylbutyrate by a dashed line with triangle markers. Error bars indicate standard error at each point.*

FDA Label Image

Figure 5 (Glycerol Phenylbutyrate Oral Liquid 6)

A line graph depicting mean (SE) normalized blood ammonia levels (μmol/L) over a 12-month period during fasting at baseline and each month from Month 1 to Month 12. Data points for Glycerol Phenylbutyrate are marked by black squares, showing fluctuations in blood ammonia levels throughout the study duration.*

FDA Label Image

Container Label (Glycerol Phenylbutyrate Oral Liquid 7)

Glycerol Phenylbutyrate Oral Liquid 1.1 grams per mL is shown on a 25 mL bottle label. The label includes dosage and storage instructions, manufacturer details (Endo USA and Annora Pharma Private Limited), and reminds pharmacists to dispense with a measuring device and medication guide. The label is marked for prescription use only with NDC 49884-264.*

FDA Label Image

Carton Label (Glycerol Phenylbutyrate Oral Liquid 8)

Packaging label for Glycerol Phenylbutyrate Oral Liquid 1.1 grams per mL in a 25 mL container. The label states it is for oral use only and available by prescription (Rx only). It includes storage instructions, pharmacist dispensing notes, and manufacturer information for Annora Pharma Private Limited. The labeler is Endo USA, and a barcode is present.*

* 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.