Tolvaptan Tablet
Product Images NDC 49884-768

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tolvaptan (NDC 49884-768). 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 Tablets 1)

Chemical structure of Tolvaptan, showing its complex molecular arrangement including aromatic rings, hydroxyl group, chlorine atom, and amide linkages, as depicted in the black line drawing.*

FDA Label Image

Figure-1 (Tolvaptan Tablets 2)

Line graph showing mean serum sodium levels (± SD) over a 30-day treatment period and a 7-day follow-up comparing Tolvaptan 15-60 mg (n=213) and placebo (n=203). The y-axis represents serum sodium in mEq/L, and the x-axis shows treatment days from baseline to day 30 and follow-up. Tolvaptan shows a steady increase in serum sodium over time compared to placebo, with statistical significance indicated at multiple time points.*

FDA Label Image

Figure-2 (Tolvaptan Tablets 3)

A line graph comparing mean serum sodium levels (± SD, mEq/L) over multiple treatment days between Tolvaptan 15-60 mg (n=110) and placebo (n=105). Tolvaptan shows increasing serum sodium levels over time with statistical significance (p<0.0001) versus placebo, which remains relatively stable.*

FDA Label Image

Figure-3 (Tolvaptan Tablets 4)

A line graph showing mean serum sodium levels (±SD, mEq/L) over time in patients treated with Tolvaptan 15-60 mg (N=111). The x-axis displays time from baseline through day 50, divided into days and weeks including a washout period. The y-axis shows mean serum sodium ranging approximately from 122 to 142 mEq/L. Data points indicate a statistically significant increase in serum sodium from baseline (p<0.0001) throughout the treatment period.*

FDA Label Image

Tolvaptan-blister-15mg (Tolvaptan Tablets 5)

Tolvaptan 15 mg tablet label distributed by Par Pharmaceutical, Chestnut Ridge, NY. The label shows the NDC 49884-768-52, manufacturing license number TN00002121, and indicates the product is made in India. The label includes space for lot number and expiration date, a barcode, and the product strength prominently displayed as 15 mg.*

FDA Label Image

Tolvaptan-15mg-carton (Tolvaptan Tablets 6)

Packaging label for Tolvaptan Tablets 15 mg by Par Pharmaceutical. The label states it contains 10 tablets per carton, with directions to store at 20° to 25°C (68° to 77°F). The medication is Rx only and includes a boxed warning to initiate use in a hospital and dispense a medication guide. Distributor is Par Pharmaceutical, manufactured by Par Formulations Private Limited, India.*

FDA Label Image

Tolvaptan-blister-30mg (Tolvaptan Tablets 7)

This is a label sheet for Tolvaptan 30 mg tablets by Par Pharmaceutical, distributed by Par Health USA, LLC. Each label includes the proprietary name Tolvaptan Tablet, active ingredient strength 30 mg, and manufacturing details indicating the product is made in India with license number TN00002121. Labels also feature a unique barcode and areas designated for lot number and expiration date.*

FDA Label Image

Tolvaptan-30mg-carton (Tolvaptan Tablets 8)

Packaging label for Tolvaptan Tablets 30 mg, containing 10 tablets per carton. The label states the product is Rx only and must initiate use in a hospital with a medication guide. Distributed by Par Pharmaceutical and manufactured by Par Formulations Private Limited in India. The label includes storage instructions and 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.