Sapropterin Dihydrochloride Powder, For Solution
Product Images NDC 49884-948

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 49884-948). 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 across study visits for two age groups: 1 month to less than 2 years, and 2 to less than 7 years. The graph includes 95% confidence interval error bars and a dotted line indicating the target blood Phe control range.*
FDA Label Image

Figure-g (Sapropterin Dihydrochloride Powder For Oral Soluti 10)

Figure-g (Sapropterin Dihydrochloride Powder For Oral Soluti 10)
An instructional illustration showing a person administering oral medication to a child using a dosing syringe placed in the child's mouth. The hand holding the syringe is positioned to deliver the liquid medicine orally.*
FDA Label Image

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 11)

Sapropterin (Sapropterin Dihydrochloride Powder For Oral Soluti 11)
Packaging label for Sapropterin Dihydrochloride Powder for Oral Solution 100 mg, distributed by Par Pharmaceutical and labeled with 30 individual packets per carton. The label includes storage instructions, dosage directions, and manufacturing details by Par Formulations Private Limited, India. The NDC is 49884-948, and it features the PAR Pharmaceutical logo.*
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 100 mg by Par Pharmaceutical. The front panel shows dosage strength, directions to dissolve the contents, storage conditions, and safety warnings. The back panel lists distributor Par Pharmaceutical (Chestnut Ridge, NY) and manufacturer Par Formulations Private Limited (India), along with a barcode and manufacturing license details.*
FDA Label Image

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

Chem-stru (Sapropterin Dihydrochloride Powder For Oral Soluti 2)
Chemical structure of sapropterin dihydrochloride, showing its molecular arrangement including amine, hydroxyl, carbonyl groups, and the associated dihydrochloride (2 HCl) units.*
FDA Label Image

Figure-2 (Sapropterin Dihydrochloride Powder For Oral Soluti 3)

Figure-2 (Sapropterin Dihydrochloride Powder For Oral Soluti 3)
A line graph depicting blood phenylalanine (Phe) levels (µmol/L) over several weeks in two groups: one treated with Sapropterin Dihydrochloride and a placebo group. The graph shows measurements from week -2 through week 6, highlighting a significant decrease in blood Phe levels in the Sapropterin group compared to the placebo, with a noted p-value < 0.001.*
FDA Label Image

Figure-a (Sapropterin Dihydrochloride Powder For Oral Soluti 4)

Figure-a (Sapropterin Dihydrochloride Powder For Oral Soluti 4)
Illustration showing an oral dosing syringe labeled with its parts: plunger, barrel, and tip. Below the syringe are two cups, one labeled 'medicine cup' and the other labeled 'water or apple juice cup,' indicating containers used for dosing liquid medication.*
FDA Label Image

Figure-b (Sapropterin Dihydrochloride Powder For Oral Soluti 5)

Figure-b (Sapropterin Dihydrochloride Powder For Oral Soluti 5)
An instructional illustration labeled Figure B showing powder being poured into a medicine cup. The cup is marked with a liquid line to indicate the level of liquid for solution preparation.*
FDA Label Image

Figure-c (Sapropterin Dihydrochloride Powder For Oral Soluti 6)

Figure-c (Sapropterin Dihydrochloride Powder For Oral Soluti 6)
An instructional illustration showing a hand pouring powder from a SAPROPTERIN DIHYDROCHLORIDE single-dose packet into a medicine cup. The image is labeled with the text 'MEDICINE CUP' indicating where the powder is being poured for oral preparation.*
FDA Label Image

Figure-d (Sapropterin Dihydrochloride Powder For Oral Soluti 7)

Figure-d (Sapropterin Dihydrochloride Powder For Oral Soluti 7)
An instructional illustration showing a hand stirring a liquid in a small medicine cup using a spoon, labeled 'MEDICINE CUP'. The image likely demonstrates how to mix or prepare the SAPROPTERIN DIHYDROCHLORIDE powder for oral solution.*
FDA Label Image

Figure-e (Sapropterin Dihydrochloride Powder For Oral Soluti 8)

Figure-e (Sapropterin Dihydrochloride Powder For Oral Soluti 8)
An instructional illustration showing a hand holding a syringe being dipped into a medicine cup filled with liquid. The image is labeled 'MEDICINE CUP' and depicts preparation steps related to oral administration of medication, likely for SAPROPTERIN DIHYDROCHLORIDE powder for solution.*
FDA Label Image

Figure-f (Sapropterin Dihydrochloride Powder For Oral Soluti 9)

Figure-f (Sapropterin Dihydrochloride Powder For Oral Soluti 9)
An instructional illustration showing a hand holding a syringe with labeled parts 'TIP' and 'LIQUID LINE.' The image appears to demonstrate proper liquid measurement or administration techniques associated with SAPROPTERIN DIHYDROCHLORIDE powder for solution oral dosage.*

* 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.