Sapropterin Dihydrochloride Tablet
Product Images NDC 0054-0906

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Sapropterin Dihydrochloride (NDC 0054-0906). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals Usa 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

Sapropterin Dihydrochloride-figure1.jpg (Sapropterin Dihydrochloride Figure1)

A line chart showing blood phenylalanine (Phe) levels (µmol/L) over time during study visits for two age groups: 1 month to less than 2 years (solid line) and 2 to less than 7 years (dashed line). Blood Phe levels are plotted from baseline through week 4, month 3, and month 6 with error bars. A dotted horizontal line indicates the target blood Phe control range between about 120 µmol/L and 240 µmol/L.*

FDA Label Image

Sapropterin Dihydrochloride-figure2.jpg (Sapropterin Dihydrochloride Figure2)

A line graph depicting blood phenylalanine (Phe) levels in micromoles per liter (µmol/L) over study visits labeled from Week -2 to Week 6. Two groups are compared: one receiving sapropterin dihydrochloride and the other placebo. Blood Phe levels in the sapropterin group decrease notably after Week 0, while levels in the placebo group remain relatively stable. Data points include error bars, and a statistical significance marker (p < 0.001) is shown.*

FDA Label Image

Sapropterin Dihydrochloride-chem-structure.jpg (Sapropterin Dihydrochloride Chem Structure)

Chemical structure of sapropterin dihydrochloride, showing the molecular arrangement including amine, hydroxyl groups, and chloride ions (2HCl).*

FDA Label Image

Bl-sapropterin-tabs.jpg (Bl Sapropterin Tabs.jpg)

The label for Sapropterin Dihydrochloride Tablets 100 mg by Hikma Pharmaceuticals USA Inc. The label includes dosage strength, storage instructions, barcode, quantity (120 tablets), and manufacturer information for Zenara Pharma Private Limited in India. The label also notes that the product is prescription-only and provides storage temperature ranges.*

FDA Label Image

Fc-sapropterin-tabs.jpg (Fc Sapropterin Tabs.jpg)

Packaging label for Sapropterin Dihydrochloride Tablets, 100 mg strength, supplied in a 120-tablet count. Distributed by Hikma Pharmaceuticals USA Inc., manufactured by Zenara Pharma Private Limited, India. The label features dosage form as oral tablets and includes storage instructions, barcode, and manufacturer details. The label also displays the NDC 0054-0906-23 and the Hikma logo.*

* 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.