Sevelamer Carbonate Tablet, Film Coated
Product Images NDC 0955-1050

7 FDA label images from Sanofi-aventis U.s. Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Sevelamer Carbonate (NDC 0955-1050). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sanofi-aventis U.s. Llc, 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

Chemical Structure (Sevelamer 01)

Chemical Structure (Sevelamer 01)
Chemical structure diagram of Sevelamer Carbonate showing the polymeric repeating units with functional groups including amino, hydroxyl, and bicarbonate ions.*
FDA Label Image

Figure 2 (Sevelamer 02)

Figure 2 (Sevelamer 02)
A forest plot illustrating the effects of Sevelamer Carbonate versus placebo across subgroups including overall population, screening BSA, baseline serum phosphorus levels, age, and dialysis status. The plot displays estimates with 95% confidence intervals, where values to the left favor Sevelamer Carbonate and values to the right favor placebo.*
FDA Label Image

Figure 3 (Sevelamer 03)

Figure 3 (Sevelamer 03)
A line graph illustrating the percentage of patients achieving various degrees of reduction in serum phosphorus (mg/dL) with Sevelamer Hydrochloride compared to an active control. The x-axis represents the reduction in serum phosphorus, ranging from -4 (worsened increase) to 8 mg/dL (improved reduction), and the y-axis shows the percentage of patients with corresponding reduction percentages.*
FDA Label Image

Figure 4 (Sevelamer 04)

Figure 4 (Sevelamer 04)
A line graph depicting phosphorus change from baseline over 52 study weeks. The x-axis represents study weeks from 0 to 52, and the y-axis shows phosphorus change values from -5 to 2. Two treatment groups are compared: Sevelamer Hydrochloride and Active-Control, with Sevelamer Hydrochloride represented by black circles and Active-Control by open red squares.*
FDA Label Image

Principal Display Panel (800 mg Bottle Label)

Principal Display Panel (800 mg Bottle Label)
Label for Sevelamer Carbonate Tablets 800 mg by Sanofi, under the Winthrop brand. The label states 270 film-coated tablets per bottle, includes barcode and dosage information, and notes storage at 25°C. Manufactured for Winthrop U.S., a Sanofi company, with origin in the U.K.*
FDA Label Image

Principal Display Panel (0.8 g Packet Box)

Principal Display Panel (0.8 g Packet Box)
Box packaging label for Sevelamer Carbonate 0.8 g powder for oral suspension in citrus flavor by Sanofi-Aventis U.S. LLC. The label indicates it contains 90 packets and is marked Rx only. The manufacturer is identified as Winthrop, a Sanofi company, with NDC 0955-1052-90.*
FDA Label Image

Principal Display Panel (2.4 g Packet Box)

Principal Display Panel (2.4 g Packet Box)
Packaging label for Sevelamer Carbonate 2.4 g powder for oral suspension. The label shows the product name, citrus flavor, and dosage strength repeated multiple times. It indicates the package contains 90 packets. The labeler is Sanofi, marketed under the Winthrop brand, a Sanofi company. The label includes NDC 0955-1054-90 and states Rx only.*

* 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.