Cinacalcet Tablet, Film Coated
Product Images NDC 84386-112

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Cinacalcet (NDC 84386-112). 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.

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Figure 1. Mean (se) Ipth Values (pooled Phase 3 Studies) (Cinacalcet Fig1)

A line chart comparing mean intact parathyroid hormone (iPTH) levels over 25 weeks between placebo and Cinacalcet groups in pooled Phase 3 studies. The vertical axis shows iPTH levels in pg/mL, and the horizontal axis shows time in weeks. Cinacalcet shows a marked decrease in iPTH levels over time compared to placebo.*

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

Line graph titled 'Mean (SE) Ca x P Values (Pooled Phase 3 Studies)' showing calcium-phosphorus product values over 26 weeks. Two lines compare Placebo and Cinacalcet groups, with the Cinacalcet line showing a decrease and sustained lower Ca x P levels compared to the Placebo. The y-axis represents Ca x P (mg/dL)² values, and the x-axis indicates time in weeks.*

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Figure 3 (Cinacalcet Fig3)

A line graph depicting serum calcium values (mg/dL) in patients with parathyroid carcinoma receiving Cinacalcet over baseline, titration, and maintenance phases. The x-axis represents weeks from baseline through titration to maintenance, with patient sample sizes indicated. The y-axis shows calcium levels ranging from 8 to 16 mg/dL, with data points showing a decrease and stabilization of serum calcium during treatment.*

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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 calcium (mg/dL) levels over time in weeks, including titration and maintenance phases, with error bars indicating variability. The x-axis marks weeks up to 80, and the y-axis ranges from 8 to 16 mg/dL calcium concentration. The graph depicts a trend with initial elevated calcium levels that decrease and stabilize through the maintenance period.*

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Package Label (PRINCIPAL DISPLAY PANEL)

Label for Cinacalcet Tablets 30 mg film-coated tablets, package of 30, distributed by Aurobindo Pharma USA, Inc. The label states each tablet contains 33 mg Cinacalcet Hydrochloride equivalent to 30 mg Cinacalcet. It includes storage instructions, distributor address, manufacturer origin (India), and notes about coding area and packaging details.*

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Package Label (PRINCIPAL DISPLAY PANEL)

Label for Cinacalcet 60 mg film-coated tablets by Aurobindo Pharma Limited, containing 30 tablets. Shows NDC 84386-112-30, manufacturer details, storage instructions, and barcode. States each tablet contains cinacalcet hydrochloride equivalent to 60 mg cinacalcet.*

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Package Label (PRINCIPAL DISPLAY PANEL)

Label for Cinacalcet Tablets 90 mg film-coated tablets, supplied in a container of 30 tablets. The label states each tablet contains 99 mg Cinacalcet Hydrochloride equivalent to 90 mg Cinacalcet. Distributed by Aurobindo Pharma USA, Inc., made in India. Storage instructions and usual dosage reference are included, along with a barcode and branding.*

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Chemical Structure (Cinacalcet Str)

Chemical structure of the active ingredient cinacalcet hydrochloride, showing the molecular arrangement including trifluoromethylphenyl, amine, and methyl-substituted naphthalene groups.*

* 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.