Sapropterin Dihydrochloride Tablet
Product Images NDC 49884-720

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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 Tablets 1)

Sapropterin-dihydrochloride-tablets-1.jpg (Sapropterin Dihydrochloride Tablets 1)
A line graph comparing blood phenylalanine (Phe) levels (µmol/L) over multiple study visits (weeks) between sapropterin dihydrochloride and placebo groups. The graph tracks changes from week -2 to week 6, showing lower blood Phe levels for sapropterin dihydrochloride compared to placebo, with data points and error bars included, and a statistical significance of p < 0.001.*
FDA Label Image

Sapropterin-dihydrochloride-tablets-2.jpg (Sapropterin Dihydrochloride Tablets 2)

Sapropterin-dihydrochloride-tablets-2.jpg (Sapropterin Dihydrochloride Tablets 2)
Chemical structure diagram of sapropterin dihydrochloride showing the detailed arrangement of atoms including nitrogen, oxygen, carbon, and hydrogen, with markings for the hydrochloride salts (2 HCl).*
FDA Label Image

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

Sapropterin-dihydrochloride-tablets-3.jpg (Sapropterin Dihydrochloride Tablets 3)
A line graph comparing blood phenylalanine (Phe) levels (μmol/L) over multiple study visits (Weeks -2 to 6) between sapropterin dihydrochloride and placebo groups. The sapropterin group shows a marked decrease in blood Phe levels starting at Week 1, while the placebo group maintains higher levels throughout. Error bars indicate variability; a p-value less than 0.001 is noted.*
FDA Label Image

Sapropterin-dihydrochloride-tablets-4.jpg (Sapropterin Dihydrochloride Tablets 4)

Sapropterin-dihydrochloride-tablets-4.jpg (Sapropterin Dihydrochloride Tablets 4)
Label for Sapropterin Dihydrochloride Tablets 100 mg, oral dosage form, containing 120 tablets. The label includes dosage information, storage instructions, and manufacturer details, distributed by Par Pharmaceutical and made in India. It also features the NDC 49884-720 and a barcode.*

* 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.