Cinacalcet
Product Images NDC 65862-832

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Cinacalcet (NDC 65862-832). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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. Mean (se) Ipth Values (pooled Phase 3 Studies) (Cinacalcet Fig1)

A line graph titled 'Mean (SE) iPTH Values (Pooled Phase 3 Studies)' comparing placebo and cinacalcet treatments over 25 weeks. The y-axis shows iPTH levels in pg/mL, ranging from 0 to 1000, and the x-axis displays weeks from 0 to 25. Two curves represent declining iPTH levels for cinacalcet and stable levels for placebo.*

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Figure 2. Mean (se) Ca X P Values (pooled Phase 3 Studies) (Cinacalcet Fig2)

A line graph showing mean (SE) calcium times phosphorus (Ca x P) values over 26 weeks from pooled Phase 3 studies comparing placebo and Cinacalcet. The y-axis indicates Ca x P values in mg/dL squared, and the x-axis shows time in weeks, depicting decreasing values for Cinacalcet and stable values for placebo.*

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Figure 3 (Cinacalcet Fig3)

A line graph titled 'Serum Calcium Values in Patients with Parathyroid Carcinoma Receiving Cinacalcet at Baseline, Titration, and Maintenance Phase.' The y-axis shows serum calcium levels in mg/dL, ranging from 8 to 16, and the x-axis shows time in weeks from baseline to 80 weeks. Data points with error bars illustrate serum calcium trends over titration and maintenance phases, with subject numbers noted below the timeline.*

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Figure 4. Mean Serum Calcium (se) At Baseline, End Of Titration, And Scheduled Maintenance Visits (patients With Severe Intractable Primary Hpt) (Cinacalcet Fig4)

A line graph showing serum calcium levels (mg/dL) over 80 weeks in patients, labeled with phases 'Titration' and 'Maintenance'. The x-axis represents time in weeks, including baseline (B), end of titration (EOT), and various weeks up to 80. The y-axis shows calcium concentration ranging from 8 to 16 mg/dL, with data points and error bars illustrating changes over time. The graph pertains to Cinacalcet as per the product context.*

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Package Label (PRINCIPAL DISPLAY PANEL)

Label for Cinacalcet Tablets 30 mg, containing 30 film-coated tablets. Distributed by Aurobindo Pharma USA, Inc., made in India. The label includes storage instructions, dosage reference, and NDC 65862-831-30, with branding and barcode present.*

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Package Label (PRINCIPAL DISPLAY PANEL)

Label for Cinacalcet Tablets 60 mg film-coated tablets, containing 30 tablets per package. The label includes NDC 65862-832-30 and storage instructions at controlled room temperature. Distributed by Aurobindo Pharma USA, Inc. and made in India. The label also features a barcode and regulatory information.*

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Package Label (PRINCIPAL DISPLAY PANEL)

Cinacalcet Tablets 90 mg film-coated tablets carton label showing NDC 65862-833-30. The label states the active ingredient as Cinacalcet Hydrochloride 99 mg equivalent to 90 mg cinacalcet. The package contains 30 tablets, is labeled Rx only, and is distributed by Aurobindo Pharma USA, Inc. Made in India. Storage information and dosage reference are included.*

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Chemical Structure (Cinacalcet Str)

Chemical structure of Cinacalcet hydrochloride showing its molecular arrangement, including trifluoromethylbenzyl and naphthyl groups attached to an amine and methyl side chain.*

* 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.