Sapropterin Dihydrochloride Tablet
Product Images NDC 49884-720

4 FDA label images from Par Health Usa, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Sapropterin Dihydrochloride (NDC 49884-720). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Par Health Usa, 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

Sapropterin-dihydrochloride-tablets-1.jpg (Sapropterin Dihydrochloride 1)

Sapropterin-dihydrochloride-tablets-1.jpg (Sapropterin Dihydrochloride 1)
Line graph comparing blood phenylalanine (Phe) levels in micromoles per liter (µmol/L) over time (study visits from week -2 to week 6) between sapropterin dihydrochloride and placebo groups. The graph shows a significant decrease in blood Phe levels with sapropterin dihydrochloride starting at week 1, while placebo levels remain higher. Data points include error bars, with p-value indicated as less than 0.001.*
FDA Label Image

Sapropterin-dihydrochloride-tablets-2 (Sapropterin Dihydrochloride 2)

Sapropterin-dihydrochloride-tablets-2 (Sapropterin Dihydrochloride 2)
Chemical structure of sapropterin dihydrochloride, illustrating its molecular arrangement with labeled carbon atoms and functional groups, including hydroxyl and amino groups, along with two hydrochloride units indicated.*
FDA Label Image

Sapropterin-dihydrochloride-tablets-3.jpg (Sapropterin Dihydrochloride 3)

Sapropterin-dihydrochloride-tablets-3.jpg (Sapropterin Dihydrochloride 3)
A line graph comparing blood phenylalanine (Phe) levels in micromoles per liter over multiple study visits (Weeks -2 to 6) for sapropterin dihydrochloride versus placebo groups. The sapropterin group shows a decrease in blood Phe level after Week 0, while the placebo group remains stable. Statistical significance (p < 0.001) is noted.*
FDA Label Image

Container Label (Sapropterin Dihydrochloride 4)

Container Label (Sapropterin Dihydrochloride 4)
Label for Sapropterin Dihydrochloride Tablets 100 mg oral tablets by Par Health USA, LLC. The bottle contains 120 tablets. The label includes dosage information, storage instructions, and a barcode. NDC 49884-720-08 is displayed prominently.*

* 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.