Kuvan Powder, For Solution
Product Images NDC 68135-482

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Kuvan (NDC 68135-482). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biomarin Pharmaceutical 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

Figure 1 (Kuvan 1)

A line graph titled 'Mean Blood Phe Level Over Time by Age (years) (N=57)' comparing blood phenylalanine levels (μmol/L) over various study visits. It shows two groups: '1 month to <2 years' (solid line) and '2 to <7 years' (dashed line), along with a target blood Phe control range indicated by dotted lines. Error bars represent the 95% confidence interval.*

FDA Label Image

Figure F (Kuvan 10)

An instructional illustration showing a hand holding an oral syringe with a labeled tip and a liquid line at the 5 ml mark, demonstrating how to measure liquid medication accurately for oral administration.*

FDA Label Image

Figure G (Kuvan 11)

An instructional line drawing showing an infant receiving an oral liquid dose by a caregiver using an oral syringe aimed at the infant's mouth.*

FDA Label Image

Biomarin Pharmaceutical Inc. (Kuvan 12)

FDA Label Image

100 mg Tablet Pdp (Kuvan 13)

Kuvan tablets containing sapropterin dihydrochloride, 100 mg strength, in a package of 120 tablets. The label displays the BioMarin Pharmaceutical Inc. logo and states the dosage form as tablets, with a note that 100 mg is equivalent to 76.8 mg of sapropterin. Prescription use only. The NDC is 68135-300-02.*

FDA Label Image

100 mg Powder Pdp (Kuvan 14)

The label displays Kuvan, containing sapropterin dihydrochloride as a powder for oral solution, with a strength of 100 mg. The packaging indicates it is a prescription-only product with 30 individual packets per carton and is labeled by BioMarin Pharmaceutical Inc.*

FDA Label Image

Kuvan 500 Carton Pdp (Kuvan 15)

Kuvan 500 mg powder for oral solution single use packet label displaying the proprietary and generic name sapropterin dihydrochloride. The label notes the active equivalent sapropterin content and indicates the carton contains 30 single use packets. The labeler is BioMarin Pharmaceutical Inc.*

FDA Label Image

Structural Formula (Kuvan 2)

Chemical structure of sapropterin dihydrochloride, the active ingredient in Kuvan (sapropterin dihydrochloride) powder for solution, oral.*

FDA Label Image

Figure 2 (Kuvan 3)

A line graph depicting the mean blood phenylalanine (Phe) levels over time in a study comparing Kuvan and placebo. The x-axis shows study visits from week -2 to week 6, and the y-axis shows blood Phe levels in µmol/L, ranging from 0 to 1100. Kuvan's Phe levels decrease significantly starting week 0, while placebo levels remain relatively stable. Error bars represent 95% confidence intervals. A statistical significance marker (p < 0.001) is noted.*

FDA Label Image

Bmrn Logo (Kuvan 4)

FDA Label Image

Figure A (Kuvan 5)

An illustration showing an oral dosing syringe labeled with parts 'barrel,' 'tip,' and 'plunger.' Below the syringe, there are two labeled cups: a smaller 'medicine cup' and a larger 'water or apple juice cup,' depicting common containers used for oral medication administration.*

FDA Label Image

Figure B (Kuvan 6)

An instructional illustration showing liquid being poured into a medicine cup. The cup has marked measurement lines, and an arrow pointing to one line is labeled 'liquid line.' The cup itself is labeled 'medicine cup.' This diagram demonstrates filling a medicine cup to a specified liquid level, likely for dosing.*

FDA Label Image

Figure C (Kuvan 7)

An instructional illustration showing a hand pouring powder from a Kuvan sachet into a medicine cup filled with liquid. The image depicts the preparation of Kuvan (sapropterin dihydrochloride) oral powder for solution.*

FDA Label Image

Figure D (Kuvan 8)

An instructional illustration showing a hand stirring liquid in a medicine cup with a spoon. The image emphasizes the proper method of mixing, labeled as 'medicine cup.' This relates to preparation or administration of a drug in liquid form.*

FDA Label Image

Figure E (Kuvan 9)

An instructional illustration showing a hand drawing liquid from a medicine cup using a syringe. The medicine cup is labeled, indicating the use of an oral liquid dose measurement tool.*

* 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.