Javygtor Powder, For Solution
Product Images NDC 43598-162

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Javygtor (NDC 43598-162). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dr. Reddys Laboratories Inc, 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

Figure1 (Figure1)

A line graph depicting blood phenylalanine (Phe) levels (µmol/L) over study visits for two age groups: 1 month to under 2 years (solid line) and 2 to under 7 years (dashed line). It shows mean blood Phe levels with 95% confidence intervals, including a dotted line indicating the target blood Phe control range over baseline up to month 6.*

FDA Label Image

Carton (Carton)

Packaging label for JAVYGTOR (sapropterin dihydrochloride) 500 mg powder for oral solution. The carton contains 30 single-use packets and is labeled for prescription use only. The product is manufactured and distributed by Dr. Reddy's Laboratories Inc. Directions and storage instructions are included on the carton, along with the NDC 43598-162.*

FDA Label Image

Figure2 (Figure2)

A line graph displaying blood PK levels (µmol/L) over multiple study visits from week -2 to week 6. Two groups are shown: Sapropterin Dihydrochloride (solid circles) and placebo (open circles). The graph indicates a statistically significant decrease in blood PK level for Sapropterin Dihydrochloride compared to placebo (p < 0.001), with 95% confidence interval error bars included.*

FDA Label Image

Figurea (Figurea)

An instructional illustration showing an oral dosing syringe labeled with barrel, tip, and plunger. Below the syringe are two labeled cups: a medicine cup and a water or apple juice cup. The image guides the use of the oral dosing syringe for administering liquid medication.*

FDA Label Image

Figureb (Figureb)

An instructional illustration showing powder being poured into a medicine cup with a labeled liquid line. The image demonstrates how to measure the liquid level when preparing a solution, relevant for oral administration of a powder-for-solution medication.*

FDA Label Image

Figurec (Figurec)

An instructional illustration depicting a hand pouring JAVYGTOR 500 mg powder for solution from a packet into a medicine cup. The image focuses on the proper transfer of the powder into the cup for oral administration.*

FDA Label Image

Figured (Figured)

An instructional illustration showing a hand stirring a liquid in a medicine cup with a spoon. The image emphasizes the action of mixing the contents inside the cup, likely related to preparing an oral powder for solution.*

FDA Label Image

Figuree (Figuree)

An instructional black-and-white illustration showing hands using a syringe to draw liquid from a medicine cup. The medicine cup is partially filled, and the image highlights the proper method of drawing medication from the cup into the syringe for oral administration.*

FDA Label Image

Figuref (Figuref)

An instructional diagram illustrating the proper way to hold a dosing syringe. The image shows a hand holding the syringe with labels pointing to the 'tip' and the 'liquid line' to indicate measurement points for preparing the oral solution dose.*

FDA Label Image

Figureg (Figureg)

An instructional illustration showing a child receiving oral medication via a syringe held by a hand, demonstrating proper administration of an oral solution dosage form.*

FDA Label Image

Sachet (Sachet)

JAVYGTOR 500 mg powder for oral solution single-use packet label. Front displays product name, active ingredient sapropterin dihydrochloride, dosage form, strength, storage instructions, and Dr. Reddy's logo. Back shows distributor information for Dr. Reddy's Laboratories, Princeton, NJ, manufacturing origin Switzerland, and a barcode.*

FDA Label Image

Structure (Structure)

Chemical structure of Sapropterin Dihydrochloride showing its molecular framework with multiple nitrogen atoms, hydroxyl groups, and two hydrochloride moieties.*

* 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.