Sapropterin Dihydrochloride Tablet
Product Images NDC 31722-045

5 FDA label images from Camber Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Sapropterin Dihydrochloride (NDC 31722-045). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Camber 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

Sapropterindihydrochloridefigure1 (Sapropterindihydrochloridefigure1)

Sapropterindihydrochloridefigure1 (Sapropterindihydrochloridefigure1)
A line graph depicting blood phenylalanine (Phe) levels (in µmol/L) over time (study visits) for two age groups: 1 month to less than 2 years and 2 to less than 7 years, with error bars showing 95% confidence intervals. The graph also shows a target blood Phe control range as a dotted line. The x-axis represents study visits from baseline through month 6.*
FDA Label Image

Apropterindihydrochloridestructure (Sapropterindihydrochloridestructure)

Apropterindihydrochloridestructure (Sapropterindihydrochloridestructure)
Chemical structure of sapropterin dihydrochloride showing the molecular arrangement with labeled atoms and hydroxyl groups, along with the indication of two hydrochloride (2 HCl) units.*
FDA Label Image

Sapropterindihydrochloridefigure2 (Sapropterindihydrochloridefigure2)

Sapropterindihydrochloridefigure2 (Sapropterindihydrochloridefigure2)
Line graph showing blood phenylalanine (Phe) levels in μmol/L over several study visits from week -2 to week 6. Two groups are compared: sapropterin dihydrochloride (solid circles) and placebo (open circles). The graph indicates that blood Phe levels decreased notably in the sapropterin dihydrochloride group starting at week 1, while levels remained relatively stable in the placebo group. Statistical significance is noted with p < 0.001.*
FDA Label Image
FDA Label Image

Sapropterindihydrochloridetabletscontainer (Sapropterindihydrochloridetabletscontainer)

Sapropterindihydrochloridetabletscontainer (Sapropterindihydrochloridetabletscontainer)
Label for Sapropterin Dihydrochloride Tablets 100 mg by Camber Pharmaceuticals, Inc. The label displays the product name, strength, dosage form, and quantity of 120 tablets. It includes storage instructions, contact information, a barcode, and manufacturing details. The label is designed for oral human prescription use.*

* 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.