Sapropterin Dihydrochloride Powder, For Solution
Product Images NDC 49884-873

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

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Sapropterin Dihydrochloride (NDC 49884-873). 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 (Sapropterin Dihydrochloride Powder For Oral Soluti 1)

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 1)
A line graph depicting blood phenylalanine (Phe) levels (µmol/L) over time from baseline to month 6 in two age groups: 1 month to less than 2 years (solid line) and 2 to less than 7 years (dashed line). The x-axis represents study visits from baseline through weeks and months, and the y-axis shows blood Phe levels with error bars. A dotted line indicates the target blood Phe control range, serving as a reference for both groups throughout the study.*
FDA Label Image

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 10)

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 10)
An instructional black-and-white illustration showing a hand administering oral medication to a baby's mouth using a graduated oral dosing syringe. The image demonstrates the correct positioning of the syringe for oral administration.*
FDA Label Image

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 11)

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 11)
SAPROPTERIN DIHYDROCHLORIDE 500 mg powder for oral solution single-use packet packaging label. The label includes dosage strength, NDC 49884-873-52, instructions to dissolve contents for use, storage conditions at 20° to 25°C with excursions permitted, and warnings to keep out of reach of children. Distributed by Par Pharmaceutical, manufactured by Par Formulations Private Limited in India, with barcodes and lot information.*
FDA Label Image

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 12)

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 12)
Packaging label for Sapropterin Dihydrochloride Powder for Oral Solution 500 mg per single use packet. The label indicates 30 single use packets per carton and includes storage directions, dosage instructions, and manufacturer information. Distributed by Par Pharmaceutical, manufactured by Par Formulations Private Limited in India.*
FDA Label Image

Chem-str (Sapropterin Dihydrochloride Powder For Oral Soluti 2)

Chem-str (Sapropterin Dihydrochloride Powder For Oral Soluti 2)
Chemical structure diagram of sapropterin dihydrochloride, depicting molecular formula elements and bonds with annotations of atom positions and stereochemistry, including two hydrochloride (2 HCl) components.*
FDA Label Image

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 3)

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 3)
A line graph comparing blood phenylalanine (Phe) levels (µmol/L) over time (weeks) for subjects treated with Sapropterin Dihydrochloride versus placebo. The graph shows a significant decrease in blood Phe levels in the Sapropterin Dihydrochloride group starting from week 1, while the placebo group remains stable. Error bars indicate variability, and a p-value of less than 0.001 is noted.*
FDA Label Image

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 4)

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 4)
Illustration showing components of an oral dosing syringe including tip, barrel, and plunger. Also depicted are two measuring cups labeled as medicine cup and water or apple juice cup, indicating their use for medication preparation or dilution.*
FDA Label Image

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 5)

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 5)
An instructional black-and-white line drawing showing powder being poured from a container into a medicine cup. The cup has measurement markings and a labeled liquid line indicated near the bottom. This illustration likely demonstrates how to prepare an oral powder for solution dosage.*
FDA Label Image

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 6)

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 6)
An instructional illustration showing a hand pouring powder from a small sachet labeled with dosing information into a medicine cup labeled MEDICINE CUP. The powder appears to be the SAPROPTERIN DIHYDROCHLORIDE oral powder for solution product.*
FDA Label Image

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 7)

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 7)
An instructional illustration showing a hand stirring with a spoon inside a medicine cup containing liquid. The cup is labeled 'MEDICINE CUP' and arrows indicate a stirring motion with the spoon in the cup.*
FDA Label Image

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 8)

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 8)
An instructional black and white illustration showing a hand holding a syringe and drawing liquid from a medicine cup. The medicine cup is partially filled with liquid and is clearly labeled "MEDICINE CUP." This image likely demonstrates proper medication measurement or administration technique.*
FDA Label Image

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 9)

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 9)
An instructional illustration showing a hand holding a liquid measuring device. It highlights and labels the 'TIP' at the top and the 'LIQUID LINE' at the 5 ml mark on the graduated cylinder, demonstrating how to measure liquid volume accurately.*

* 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.