Sapropterin Dihydrochloride Tablet
Product Images NDC 49884-720

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)

This is a graph showing the Blood Phe Level (umol/L) for participants treated with Sapropterin Dihydrochloride compared to those given a Placebo during a study that lasted six weeks. The graph indicates a significant decrease in Blood Phe Level for those using Sapropterin Dihydrochloride when compared to the Placebo group. The X-axis shows the study visits from week -2 to week 6, and the Y-axis shows the Blood Phe Level in umol/L.*

FDA Label Image

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

FDA Label Image

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

This appears to be a clinical study evaluating the effectiveness of Sapropterin Dihydrochloride in reducing blood Phe level, as compared to a placebo. The results suggest a statistically significant difference (p < 0.001) in Phe level reduction between the treatment and placebo groups over a period of 6 weeks. The study design involved multiple visits during this period, with measurements taken at each visit.*

FDA Label Image

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

This is a medication called Sapropterin Dihydrochloride, which comes in tablet form for oral consumption. Each tablet contains 100 mg of sapropterin dihydrochloride, which is equivalent to 76.8 mg of sapropterin. It is a prescription drug and is meant to be taken only under the supervision of a physician. The recommended dosage is included in the physician package insert. It should be kept out of reach of children and protected from moisture. It is manufactured by Par Pharmaceutical in Nut Ridge, NY, USA, and is also produced in Udupakkam, Kelambakkam - 603 103, India.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.