Cinacalcet Tablet, Film Coated
Product Images NDC 16729-441

8 FDA label images from Accord Healthcare, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Cinacalcet (NDC 16729-441). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare, 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. Mean (se) Ipth Values (pooled Phase 3 Studies) (Cinacalcet 01)

Figure 1. Mean (se) Ipth Values (pooled Phase 3 Studies) (Cinacalcet 01)
A line graph comparing parathyroid hormone (PTH) levels in pg/mL over 26 weeks between Cinacalcet and placebo groups. The x-axis represents weeks, and the y-axis represents PTH levels. The Cinacalcet group shows a marked decrease in PTH levels over time, while the placebo group remains relatively stable.*
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Figure 2. Mean (se) Ca X P Values (pooled Phase 3 Studies) (Cinacalcet 02)

Figure 2. Mean (se) Ca X P Values (pooled Phase 3 Studies) (Cinacalcet 02)
A line chart comparing calcium-phosphorus (Ca x P) product levels over 26 weeks between two groups: Placebo and Cinacalcet. The y-axis represents Ca x P level in mg/dL, ranging from 0 to 70. The x-axis represents the study duration in weeks. The Cinacalcet group shows a decrease and stabilization in Ca x P levels, while the Placebo group maintains higher values throughout.*
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Figure 3. Serum Calcium Values In Patients With Parathyroid Carcinoma Receiving Sensipar At Baseline, Titration, And Maintenance Phase (Cinacalcet 03)

Figure 3. Serum Calcium Values In Patients With Parathyroid Carcinoma Receiving Sensipar At Baseline, Titration, And Maintenance Phase (Cinacalcet 03)
A line graph showing calcium levels (mg/dL) over time in patients with parathyroid carcinoma. The x-axis represents time points from baseline through titration and maintenance phases, with patient counts noted at the bottom. The y-axis shows calcium concentration ranging from 8 to 16 mg/dL, indicating changes in calcium levels 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 04)

Figure 4. Mean Serum Calcium (se) At Baseline, End Of Titration, And Scheduled Maintenance Visits (patients With Severe Intractable Primary Hpt) (Cinacalcet 04)
A line graph showing calcium concentration (mg/dL) over time in hours during titration and maintenance phases for Cinacalcet. Calcium levels decrease sharply at the beginning, then stabilize with slight fluctuations throughout maintenance, with corresponding intractable pHPT patient counts indicated below the timeline.*
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Principal Display Panel (Cinacalcet 30mg 30tab Lab)

Principal Display Panel (Cinacalcet 30mg 30tab Lab)
Cinacalcet Tablets 30 mg film-coated oral tablets packaging label. Contains product name, strength, dosage form, quantity (30 tablets), manufacturer Accord Healthcare, Inc., and manufacturing site Intas Pharmaceuticals Limited, India. Includes storage instructions, NDC 16729-440-10, and barcodes.*
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Principal Display Panel (Cinacalcet 60mg 30tab Lab)

Principal Display Panel (Cinacalcet 60mg 30tab Lab)
The packaging label for Cinacalcet Tablets, 60 mg, film-coated oral tablets. The label includes the NDC number 16729-441-10 and indicates that the box contains 30 tablets. It states that each tablet contains 60 mg of cinacalcet. The labeler is Accord Healthcare, Inc., with manufacturing by Intas Pharmaceuticals Limited in India. Storage instructions and dosage referencing the package insert are also included.*
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Principal Display Panel (Cinacalcet 90mg 30tab Lab)

Principal Display Panel (Cinacalcet 90mg 30tab Lab)
Label for Cinacalcet Tablets 90 mg film-coated oral tablets, containing 90 mg of cinacalcet hydrochloride per tablet. The package contains 30 tablets. The label indicates Accord Healthcare, Inc. as the labeler, with manufacturing by Intas Pharmaceuticals Limited, India. Storage instructions and dosage note to see package insert are also included.*
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The Following Structural Formula For Hydrochloride Salt Of Cinacalcet Is Described Chemically As N-[1-(r)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane Hydrochloride. (Cinacalcet Structure)

The Following Structural Formula For Hydrochloride Salt Of Cinacalcet Is Described Chemically As N-[1-(r)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane Hydrochloride. (Cinacalcet Structure)
Chemical structure of Cinacalcet hydrochloride, illustrating its molecular arrangement including a trifluoromethyl-substituted phenyl ring, an amine group, and a naphthyl moiety.*

* 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.