Sapropterin Dihydrochloride Powder, For Solution
Product Images NDC 42571-509

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Sapropterin Dihydrochloride (NDC 42571-509). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Micro Labs Limited, 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-crtn.jpg (Sapropterin Crtn)

This text appears to be a detailed description of a medication called Sapropterin Dihydrochloride. It is a powder for oral solution provided in single-use packets, each containing 100 mg of sapropterin dihydrochloride equivalent to 76.8 mg of sapropterin base. The medication is to be dissolved as per the package insert instructions. It is recommended to store the packets at 20° to 25°C and protect them from moisture. The product is manufactured by Micro Labs Limited in India and distributed by Micro Labs USA, Inc. in Somerset, NJ. This medication is intended for medical use and should be kept out of reach of children.*

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Sapropterin-figa.jpg (Sapropterin Figa)

This is a description of a plunger and an oral dosing syringe used for administering medicine. It mentions using either water or apple juice as a solvent for the medication. Figure A is likely a visual reference accompanying the text.*

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Sapropterin-figb.jpg (Sapropterin Figb)

This is a liquid line medicine cup used for dispensing liquid medications. It is illustrated in Figure B.*

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Sapropterin-figc.jpg (Sapropterin Figc)

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Sapropterin-figd.jpg (Sapropterin Figd)

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Sapropterin-fige.jpg (Sapropterin Fige)

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Sapropterin-figf.jpg (Sapropterin Figf)

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Sapropterin-figg.jpg (Sapropterin Figg)

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Sapropterin-figure1.jpg (Sapropterin Figure1)

This is not readable.*

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Sapropterin-figure2.jpg (Sapropterin Figure2)

This information appears to be a comparison of Blood Phe Level (umol/L) between Sapropterin Dihydrochloride and Placebo over various study visit weeks. The data includes values from 1100 umol/L to 300 umol/L. The statistical significance is shown as p<0.001 indicating a highly significant difference between the two groups.*

FDA Label Image

Sapropterin-pckt.jpg (Sapropterin Pckt)

This text provides information about a medication called Sapropterin Dihydrochloride in powder form for oral solution. Each single-use packet contains an amount equivalent to 76.8 mg of sapropterin. The directions include dissolving the contents of the packet as per the package insert. The usual dosage should be followed as mentioned in the package. The storage conditions require room temperature, protected from moisture and specific temperature excursions. The medication is manufactured in India by Micro Labs USA, Inc.*

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Sapropterin-stru.jpg (Sapropterin Stru)

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