Tolvaptan Tablet
Product Images NDC 60505-4317

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Tolvaptan (NDC 60505-4317). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

30mg10sblisters.jpg (30mg10sblisters)

Packaging label for Tolvaptan Tablets 30 mg oral tablets by Apotex Corp. The label shows a package of 10 unit-dose tablets with NDC 60505-4318-0. The label includes prescription-only status and instructions to dispense a Medication Guide, noting that treatment must initiate in a hospital setting.*

FDA Label Image

Chemical Structure (Tolvaptan 01)

Chemical structure of tolvaptan, depicting its molecular arrangement including a chlorine-substituted benzazepine ring and other functional groups typical of its chemical composition.*

FDA Label Image

Figure (Tolvaptan 02)

A line graph showing mean serum sodium levels (mEq/L) over a 30-day treatment period and a 7-day follow-up. Two groups are compared: tolvaptan 15-60 mg and placebo, with tolvaptan consistently showing higher serum sodium levels. Time points include baseline, hours on day 1, and subsequent treatment days.*

FDA Label Image

Figure (Tolvaptan 03)

A line graph comparing mean serum sodium levels (+/- SD) over 30 treatment days and a 7-day follow-up between two groups: tolvaptan 15-60 mg (solid line with filled diamonds) and placebo (dashed line with open circles). The y-axis shows serum sodium in mEq/L, and the x-axis shows treatment days. Tolvaptan groups exhibit higher sodium levels than placebo, with statistical significance indicated at multiple time points.*

FDA Label Image

Figure (Tolvaptan 04)

A line graph depicting the mean serum sodium levels (mEq/L) with standard deviation over time in weeks for tolvaptan tablets at 15-60 mg dosage. The x-axis tracks time from baseline through 50 weeks, and the y-axis shows serum sodium levels. Data points indicate changes with statistical significance noted at day 1 compared to baseline.*

FDA Label Image

Principal Display Panel (30 mg Tablet bottle label)

Label for Tolvaptan Tablets, 30 mg, in a package containing 30 tablets. The label includes storage instructions and a note that the medication must be initiated in a hospital and dispensed with an enclosed medication guide. Manufactured for Apotex Corp. The NDC number is 60505-4318-3.*

* 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.