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.

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Figure 1 (Kuvan 1)

The text describes a figure labelled as "Figure 1" which shows the mean blood Phe level over time by age (in years) based on a study with 57 participants. The figure includes a target blood Phe control range which is less than 3. The text also mentions that the error bars in the figure represent a 95% confidence interval.*

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Figure F (Kuvan 10)

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Figure G (Kuvan 11)

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Biomarin Pharmaceutical Inc. (Kuvan 12)

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100 mg Tablet Pdp (Kuvan 13)

This appears to be a medication with the NDC 68135-300-02. The name of the medication is "Uvan" and it contains sapropterin ivydrochloride in tablet form with a strength of 100mg, which is equivalent to 76.8mg of sapropterin. The medication is manufactured by Biomarin. The package contains 120 tablets and it is available by prescription only.*

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100 mg Powder Pdp (Kuvan 14)

This is a medication with the NDC code 68135-301-22, called KUVAN', which contains the active ingredient sapropterin dihydrochloride in the form of powder for oral solution. Each carton contains 30 individual packets, with a strength of 100mg. It is manufactured by BioMarin®.*

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Kuvan 500 Carton Pdp (Kuvan 15)

This is a product description for KUVAN, a powder for oral solution used to treat certain genetic disorders. Each single-use packet contains 500 mg of sapropterin dihydrochloride, equivalent to 384 mg of sapropterin. The product is packaged in cartons containing 30 single-use packets. The NDC number for this product is 6813548211 and it is manufactured by BiOMARIN.*

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Structural Formula (Kuvan 2)

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Figure 2 (Kuvan 3)

The figure shows the mean blood phenylalanine (Phe) level over time for two treatments - Kuvan and Placebo. The graph shows that Kuvan treatment had a significant effect in reducing the Phe levels when compared to the Placebo treatment. The error bars indicate the 95% confidence interval.*

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Bmrn Logo (Kuvan 4)

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Figure A (Kuvan 5)

The text is describing two medical devices: a plunger and an oral dosing syringe. The plunger's specific use is not described, but the oral dosing syringe is used to administer medicine mixed with water, apple juice or other juices. Additionally, a cup may be used to mix the medicine with the fluids mentioned.*

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Figure B (Kuvan 6)

This text describes two objects commonly found in medical settings: a "liquid line" which could refer to a tube or hose used to transport fluids, and a "medicine cup" which is a small, disposable cup used for measuring and administering liquid medication.*

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Figure C (Kuvan 7)

A medicine cup is a small cup or container used to measure and dispense medications or other liquids for medical purposes.*

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Figure D (Kuvan 8)

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Figure E (Kuvan 9)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.