Zelvysia Powder, For Solution
Product Images NDC 73289-0070

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Zelvysia (NDC 73289-0070). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aucta Pharmaceuticals, 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.

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Descrip (Description)

Chemical structure of sapropterin dihydrochloride, showing its molecular composition and arrangement, including labeled atoms, functional groups, and the 2 HCl component.*

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Fig-1 (Figure1)

A line graph titled 'Mean Blood Phe Level Over Time by Age (years) (N=57)', displaying blood phenylalanine (Phe) levels in micromoles per liter (µmol/L) over study visits from baseline to month 6. Two groups by age are shown: 1 month to under 2 years (solid line) and 2 to under 7 years (dashed line). The graph includes the target blood Phe control range and 95% confidence interval error bars for each data point.*

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Fig-2 (Figure2)

A line graph titled 'Mean Blood Phenylalanine (Phe) Level Over Time' showing changes in blood Phe levels (µmol/l) across multiple study visits from Week -2 to Week 6. Two groups are compared: sapropterin dihydrochloride and placebo. The sapropterin group shows a marked decrease in Phe levels after Week 0, while the placebo group's levels remain relatively stable. Error bars represent 95% confidence intervals, with a reported p-value less than 0.001.*

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Fig-a (Ins 1)

An instructional diagram showing an oral dosing syringe labeled with barrel, tip, and plunger, alongside a medicine cup and a water or apple juice cup. The illustration is intended to guide proper oral dosing for medication.*

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Fig-b (Ins 2)

An instructional diagram showing liquid being poured into a medicine cup, with labels indicating the 'medicine cup' and the 'liquid line' to guide proper dosage measurement for oral liquid medication.*

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Fig-c (Ins 3)

An instructional illustration showing a hand pouring the contents of a ZELVYSIA sachet (powder for solution) into a medicine cup. The image demonstrates the correct method to empty the powder into the cup before oral administration.*

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Fig-d (Ins 4)

An instructional illustration showing a hand stirring liquid in a medicine cup with a spoon. The label 'medicine cup' identifies the container used for holding the liquid. The image indicates a swirling motion by the spoon inside the cup.*

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Fig-e (Ins 5)

An instructional black-and-white illustration showing a hand holding a syringe, which is being filled with liquid from a medicine cup. The cup is labeled 'medicine cup.' This diagram likely relates to preparing or measuring a dose of a liquid medication.*

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Fig-f (Ins 6)

An instructional illustration showing a hand holding a syringe with labeled parts: the tip at the top and the liquid line marked at 5 mL. The syringe barrel has volume measurements from 1 to 10 mL, indicating measurement of liquid volume in the syringe.*

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Fig-g (Ins 7)

An instructional illustration showing a child receiving an oral medication dose via an oral syringe held by an adult hand. The syringe is positioned at the child's mouth, demonstrating administration technique, likely related to the oral powder for solution form of ZELVYSIA (sapropterin dihydrochloride).*

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Carton-100mg (Zelvysia Carton 100mg)

Zelvysia 100 mg powder for oral solution carton label showing the product name, active ingredient sapropterin dihydrochloride, dosage form, strength, and package containing 30 individual packets. Manufactured for Aucta Pharmaceuticals, Inc., the label includes directions, storage instructions, and a barcode.*

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Carton-500mg (Zelvysia Carton 500mg)

Zelvysia 500 mg powder for oral solution carton, containing 30 single use packets. The label states the active ingredient sapropterin dihydrochloride and notes each packet contains 500 mg per single use. Manufactured by Aucta Pharmaceuticals, Inc., with storage and usage instructions also visible on the carton.*

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Foil-100mg (Zelvysia Foil 100mg)

Zelvysia 100 mg powder for oral solution label showing the proprietary name, generic name sapropterin dihydrochloride, strength, and dosing information. The label includes storage instructions to keep the product between 20°C and 25°C (68°F to 77°F) and warns to protect from moisture and keep out of reach of children. Manufactured for Aucta Pharmaceuticals, Inc., Piscataway, NJ.*

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Foil-500mg (Zelvysia Foil 500mg)

Label for Zelvysia 500 mg powder for oral solution, containing sapropterin dihydrochloride. The label shows it is a prescription drug, with dosage per single use packet and directions to dissolve contents as per instructions. It includes storage instructions and the manufacturer, Aucta Pharmaceuticals, Inc.*

* 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.