Sapropterin Dihydrochloride Tablet
Product Images NDC 59651-574

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Sapropterin Dihydrochloride (NDC 59651-574). 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

Fig1 (Sapropterin Fig1)

Line graph showing mean blood phenylalanine (Phe) levels over time by age group in a study of 57 participants. The graph plots blood Phe levels (µmol/L) against study visits from baseline to 6 months, comparing two age groups: 1 month to under 2 years, and 2 to under 7 years. A target blood Phe control range is also indicated. Error bars represent 95% confidence intervals.*

FDA Label Image

Fig2 (Sapropterin Fig2)

A line graph titled 'Mean Blood Phenylalanine (Phe) Level Over Time' comparing blood Phe levels (µmol/L) between Sapropterin dihydrochloride and placebo groups. Time points include weeks -2 to 6, showing a significant reduction in Phe levels for Sapropterin dihydrochloride compared to placebo. Error bars represent 95% confidence intervals with p-value less than 0.001.*

FDA Label Image

Fig3 (Sapropterin Fig3)

Label for Sapropterin Dihydrochloride Tablets 100 mg, oral tablets, in a package of 30 tablets. Distributed by Aurobindo Pharma USA, Inc. The label includes dosage strength, storage instructions, and barcode, with manufacturing in India by Aurobindo Pharma Limited.*

FDA Label Image

Chemical Structure (Sapropterin Str)

Chemical structure of Sapropterin Dihydrochloride. The diagram illustrates the molecular structure including the arrangement of atoms, double bonds, and hydrochloride component (2 HCl).*

* 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.