Tolvaptan Tablet
Product Images NDC 49884-770

6 FDA label images from Par Health Usa, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Tolvaptan (NDC 49884-770). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Par Health Usa, 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

Chem-stru (Tolvaptan 1)

Chem-stru (Tolvaptan 1)
Chemical structure diagram of Tolvaptan, showing its molecular framework with labeled functional groups and aromatic rings.*
FDA Label Image

Figure-1 (Tolvaptan 2)

Figure-1 (Tolvaptan 2)
A line graph comparing mean serum sodium levels (in mEq/L) over time between Tolvaptan 15-60 mg (n=213) and a placebo group (n=203). The x-axis represents treatment days from baseline through day 30 and includes a 7-day follow-up. The y-axis shows mean serum sodium with standard deviation. Tolvaptan shows consistently higher sodium levels than placebo, with several statistically significant differences (p<0.0001). Error bars denote variability within groups.*
FDA Label Image

Figure-2 (Tolvaptan 3)

Figure-2 (Tolvaptan 3)
Line graph showing mean serum sodium levels (mEq/L) over treatment days comparing Tolvaptan 15-60 mg (n=110) with placebo (n=105). Tolvaptan data points are marked with solid diamonds and placebo with open circles. Tolvaptan consistently shows higher mean serum sodium levels than placebo from 8 hours to day 30, with statistical significance indicated (p<0.0001). Error bars represent standard deviation.*
FDA Label Image

Figure-3 (Tolvaptan 4)

Figure-3 (Tolvaptan 4)
A line graph depicting mean serum sodium levels (mEq/L) with standard deviation over time for Tolvaptan 15-60 mg (N=111) from baseline through approximately 50 days. The x-axis shows baseline, days, and weeks including a washout period, while the y-axis displays mean serum sodium ranging roughly from 122 to 142 mEq/L. Points reflect significant increases versus baseline (p<0.0001).*
FDA Label Image

15mg (Tolvaptan 5)

15mg (Tolvaptan 5)
Tolvaptan Tablets 15 mg oral tablets packaging label by Par Health USA, LLC. The carton contains 10 tablets in a single strip. The front panel features the product name, strength, NDC 49884-768-54, and notes that it is Rx only with instructions to initiate use in a hospital and dispense the enclosed medication guide to each patient. The label also includes storage instructions and manufacturer information.*
FDA Label Image

30mg (Tolvaptan 6)

30mg (Tolvaptan 6)
Tolvaptan Tablets 30 mg oral dosage form packaging label by Par Health USA, LLC. The carton contains 10 tablets in one strip. The label includes storage instructions, manufacturing location (India), and a note that the medication guide must be dispensed to each patient. The label shows the NDC 49884-770-54.*

* 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.