Glycerol Phenylbutyrate Liquid
Product Images NDC 68475-807

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Glycerol Phenylbutyrate (NDC 68475-807). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Navinta 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

Structure (209d6843 10de 43fc 9ae1 2cfd2ff8ee6c 01)

Chemical structure of glycerol phenylbutyrate, showing the molecular arrangement of its phenylbutyrate groups esterified to a glycerol backbone.*

FDA Label Image

Figure-1 (209d6843 10de 43fc 9ae1 2cfd2ff8ee6c 02)

A biochemical pathway diagram showing the metabolism of Glycerol Phenylbutyrate. It illustrates the conversion of Glycerol Phenylbutyrate to Phenylbutyric Acid, then to Phenylacetate through beta oxidation. Glutamate and Glutamine are shown in related pathways involving ammonium (NH4+). Phenylacetate and Glutamine combine to form Phenylacetylglutamine, which is then excreted in urine.*

FDA Label Image

Image (209d6843 10de 43fc 9ae1 2cfd2ff8ee6c 03)

A line graph comparing mean normalized blood ammonia levels (μmol/L) over a 24-hour period at various time points (0 to 24 hours, including fasting) for two treatments: Glycerol phenylbutyrate and Sodium phenylbutyrate. The graph includes error bars representing standard error (SE) for each data point.*

FDA Label Image

Image (209d6843 10de 43fc 9ae1 2cfd2ff8ee6c 04)

A line graph depicting mean normalized blood ammonia levels (in µmol/L) with standard error bars over a 12-month period for Glycerol Phenylbutyrate treatment. The x-axis represents time points from baseline through month 12, and the y-axis shows ammonia concentration. Data points reflect stability of ammonia levels during the study.*

FDA Label Image

Image (209d6843 10de 43fc 9ae1 2cfd2ff8ee6c 05)

A line graph comparing mean normalized blood ammonia levels over time between Glycerol phenylbutyrate and Sodium phenylbutyrate. The x-axis represents time points (0 hour fasting, 6 hour, 12 hour, 24 hour fasting), and the y-axis shows mean normalized blood ammonia in umol/L. Error bars indicate standard error.*

FDA Label Image

Image (209d6843 10de 43fc 9ae1 2cfd2ff8ee6c 06)

A line graph displaying mean normalized blood ammonia levels (μmol/L) with standard error at baseline and at months 1 and 2, including fasting condition measurements, for Glycerol Phenylbutyrate.*

FDA Label Image

Container (209d6843 10de 43fc 9ae1 2cfd2ff8ee6c 07)

Label for Glycerol Phenylbutyrate Oral Liquid 1.1 grams per mL in a 25 mL bottle, manufactured by Navinta LLC. The label includes storage instructions, discard guidance 28 days after opening, barcode, and manufacturer address.*

FDA Label Image

Carton (209d6843 10de 43fc 9ae1 2cfd2ff8ee6c 08)

Carton packaging label for Glycerol Phenylbutyrate Oral Liquid 1.1 grams per mL, 25 mL, manufactured for Navinta LLC. The label displays dosage strength, storage instructions (20° to 25°C), usage directions for oral use, and pharmacist dispensing instructions. The label includes tamper seal areas and a barcode, with the product identified as Rx only.*

* 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.