Glycerol Phenylbutyrate Liquid
Product Images NDC 59651-988

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Glycerol Phenylbutyrate (NDC 59651-988). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Fig (Glycerol Fig1)

A biochemical pathway diagram showing the metabolism of Glycerol Phenylbutyrate. It illustrates the conversion of Glycerol Phenylbutyrate to Phenylbutyric Acid via ester hydrolysis by pancreatic lipases, then to Phenylacetate through beta oxidation. Parallel pathways show conversion of NH4+ and α-Ketoglutarate to Glutamate and Glutamine. Both Phenylacetate and Glutamine combine to form Phenylacetylglutamine, which is excreted in urine.*

FDA Label Image

Figure (Glycerol Fig2)

A line graph comparing mean normalized blood ammonia levels (in µmol/L) over a 24-hour period between Glycerol Phenylbutyrate Oral Liquid and Sodium Phenylbutyrate. The x-axis shows time points from 0 to 24 hours, including fasting and multiple hours post-administration. The y-axis indicates mean blood ammonia levels with standard error bars. Two lines represent the two treatments, with Glycerol Phenylbutyrate depicted by squares and Sodium Phenylbutyrate by triangles.*

FDA Label Image

Figure (Glycerol Fig3)

A line graph showing the mean (SE) normalized blood ammonia levels (µmol/L) over a 12-month period of fasting measurements for Glycerol Phenylbutyrate oral liquid. The x-axis represents time points from Baseline to Month 12, and the y-axis shows blood ammonia levels ranging from 0 to 70 µmol/L, with data points and error bars plotted throughout the study period.*

FDA Label Image

Figure (Glycerol Fig4)

A line graph comparing mean (SE) normalized blood ammonia levels (umol/L) over time for Glycerol Phenylbutyrate Oral Liquid and Sodium Phenylbutyrate. The x-axis shows time points (0-hour fasting, 8-hour, 12-hour, 24-hour fasting), and the y-axis indicates mean normalized blood ammonia levels from 0 to 70 umol/L. Two lines represent each treatment, with data points and error bars.*

FDA Label Image

Figure (Glycerol Fig5)

A line graph depicting mean normalized blood ammonia levels (µmol/L) with standard error bars over a 12-month fasting period for Glycerol Phenylbutyrate oral liquid. The x-axis represents time points from baseline through month 12, and the y-axis shows ammonia concentration ranging approximately from 10 to 70 µmol/L, illustrating stability in levels throughout the treatment period.*

FDA Label Image

Figure (Glycerol Fig6)

Label for Glycerol Phenylbutyrate oral liquid, 1.1 grams per mL, in a 25 mL container. The label includes storage instructions (20° to 25°C with permitted excursions), discard information 28 days after opening, and distributor details for Aurobindo Pharma USA, Inc. The product is made in India by Aurobindo Pharma Limited. A barcode and space for coding area details are also visible.*

FDA Label Image

Figure (Glycerol Fig7)

Packaging label for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, in a 25 mL bottle. The label includes the NDC 59651-988-25, instructions for oral use only, storage conditions, and distributor information for Aurobindo Pharma USA, Inc. The label also references a medication guide URL and advises dispensing with an appropriate measuring device.*

FDA Label Image

Str (Glycerol Str)

Chemical structure diagram of glycerol phenylbutyrate, showing the molecular arrangement of atoms and bonds characteristic of this pharmaceutical compound.*

* 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.