Glycerol Phenylbutyrate Liquid
Product Images NDC 70748-425

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Glycerol Phenylbutyrate (NDC 70748-425). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lupin Pharmaceuticals, Inc., 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

Glycerol Phenylbutyrate (Fd8b7042 85e8 4193 8ce3 2d4ca69d6371 01)

Chemical structure of glycerol phenylbutyrate, illustrating the molecular arrangement with phenyl groups and glycerol backbone.*

FDA Label Image

Figure 1: Glycerol Phenylbutyrate Mechanism Of Action (Fd8b7042 85e8 4193 8ce3 2d4ca69d6371 02)

An illustration depicting the metabolic pathway of glycerol phenylbutyrate. It shows glycerol phenylbutyrate converting to phenylbutyric acid and then to phenylacetate via beta oxidation. Phenylacetate combines with glutamine to form phenylacetylglutamine, which is excreted in urine. The diagram also includes glutamate and α-ketoglutarate steps related to ammonium (NH4+) processing.*

FDA Label Image

Figure 2 (Fd8b7042 85e8 4193 8ce3 2d4ca69d6371 03)

A line graph comparing mean normalized blood ammonia levels (in μmol/L) over a 24-hour period between glycerol phenylbutyrate and sodium phenylbutyrate. The graph shows measurements at multiple time points from fasting 0-hour to fasting 24-hour, with glycerol phenylbutyrate represented by solid squares and sodium phenylbutyrate by open triangles, including error bars for standard error.*

FDA Label Image

Figure 3 (Fd8b7042 85e8 4193 8ce3 2d4ca69d6371 04)

A line graph depicting the mean normalized blood ammonia levels (in micromoles per liter) over a 12-month period for glycerol phenylbutyrate. The x-axis shows months with fasting and non-fasting measurements, while the y-axis represents mean blood ammonia levels with standard error bars.*

FDA Label Image

Figure 4 (Fd8b7042 85e8 4193 8ce3 2d4ca69d6371 05)

A line graph comparing mean normalized blood ammonia levels (umol/L) with standard error over time at 0, 8, 12, and 24 hours fasting for glycerol phenylbutyrate and sodium phenylbutyrate. The graph shows data points for both drugs with glycerol phenylbutyrate represented by solid squares and sodium phenylbutyrate by open triangles connected by dashed lines.*

FDA Label Image

Figure 5 (Fd8b7042 85e8 4193 8ce3 2d4ca69d6371 06)

Line graph showing mean normalized blood ammonia levels (µmol/L) over a 12-month period with glycerol phenylbutyrate treatment. Data points represent monthly fasting measurements with error bars indicating standard error. Levels fluctuate around 20 µmol/L throughout the study duration.*

FDA Label Image

25 mL Bottle Cartoncountry Of Origin: Austria (Fd8b7042 85e8 4193 8ce3 2d4ca69d6371 07)

This is the packaging label for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, in a 25 mL bottle. The product is for oral use only and is manufactured by Lupin Pharmaceuticals, Inc. The label includes storage instructions, dosage information, and a barcode. It also advises pharmacists to dispense the medication guide to patients or caregivers and to use a measuring device for the prescribed dose.*

FDA Label Image

25 mL Bottle Cartoncountry Of Origin: Switzerland (Fd8b7042 85e8 4193 8ce3 2d4ca69d6371 08)

Packaging label for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, in a 25 mL size. The label includes dosage form as oral liquid, instructs for oral use only, and is manufactured by Lupin Pharmaceuticals, Inc. The label displays the NDC 70748-425-01 and provides storage instructions and pharmacist dispensing guidance.*

* 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.