Glycerol Phenylbutyrate Liquid
Product Images NDC 0121-1049

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Glycerol Phenylbutyrate (NDC 0121-1049). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Pai Holdings, Llc Dba Pai Pharma, 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

Chemical Structure (Gly Phen 1)

Chemical structure of glycerol phenylbutyrate, depicting a glycerol backbone esterified with three phenylbutyrate groups, featuring aromatic benzene rings and ester functional groups.*

FDA Label Image

Figure 1 (Gly Phen 2)

A biochemical pathway diagram depicting the metabolism of Glycerol Phenylbutyrate. It illustrates the conversion of Glycerol Phenylbutyrate to Phenylbutyric Acid by ester hydrolysis with pancreatic lipases, followed by beta oxidation to Phenylacetate. Phenylacetate and Glutamine combine to form Phenylacetylglutamine, which is then excreted in urine. The pathway also includes conversion of α-Ketoglutarate to Glutamate and then to Glutamine via ammonium (NH4+).*

FDA Label Image

Figure 2 (Gly Phen 3)

Line chart comparing mean normalized blood ammonia levels (umol/L) over a 24-hour period for Glycerol Phenylbutyrate oral liquid and Sodium Phenylbutyrate. The x-axis shows time points from fasting (0-hour) through 24-hour fasting, and the y-axis shows ammonia levels with standard error bars. Glycerol Phenylbutyrate is represented by a solid line with square markers, and Sodium Phenylbutyrate by a dashed line with triangle markers.*

FDA Label Image

Figure 3 (Gly Phen 4)

A line graph depicting mean (SE) normalized blood ammonia levels (µmol/L) over a 12-month period during fasting conditions for Glycerol Phenylbutyrate oral liquid. The x-axis shows time points from baseline through months 1 to 12, and the y-axis shows normalized blood ammonia concentrations ranging from 0 to 70 µmol/L. Data points are connected by lines with error bars representing standard error.*

FDA Label Image

Figure 4 (Gly Phen 5)

Line chart comparing mean normalized blood ammonia levels (in µmol/L) over a 24-hour period for Glycerol Phenylbutyrate oral liquid and Sodium Phenylbutyrate. The x-axis shows time points at 0-hour (fasting), 8-hour, 12-hour, and 24-hour (fasting). Glycerol Phenylbutyrate is represented by a solid line with squares, while Sodium Phenylbutyrate is shown with a dashed line and triangles, with error bars present for both.*

FDA Label Image

Figure 5 (Gly Phen 6)

A line graph showing the mean normalized blood ammonia levels (µmol/L) with standard error bars over a 12-month period of fasting measurements. The X-axis represents time points from baseline through month 12, and the Y-axis shows mean blood ammonia levels. Data is for glycerol phenylbutyrate oral liquid.*

FDA Label Image

Label For Glycerol Phenylbutyrate (Gly Phen 7)

Glycerol Phenylbutyrate Oral Liquid 1.1 grams per mL in a 25 mL container. The label states it is for oral use only and prescription use (Rx only). The labeler is PAI Holdings, LLC dba PAI Pharma, with storage instructions and a note to discard unused portions 28 days after opening. The NDC is 0121-1049-25.*

FDA Label Image

Carton For Glycerol Phenylbutyate Oral Liquid (Gly Phen 8)

Packaging label for Glycerol Phenylbutyrate Oral Liquid with strength 1.1 grams per mL in a 25 mL bottle. The label states it is for oral use only. It instructs pharmacists to dispense with a measuring device and to provide the enclosed Medication Guide to patients or caregivers. The product is distributed by PAI Pharma, Greenville, SC, and includes storage instructions and a barcode.*

* 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.