Tarpeyo Capsule, Delayed Release
Product Images NDC 81749-004

4 FDA label images from Calliditas Therapeutics Ab · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Tarpeyo (NDC 81749-004). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Calliditas Therapeutics Ab, 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

Structural Formula (Tar02 0004 01)

Structural Formula (Tar02 0004 01)
Chemical structure diagram of budesonide, the active ingredient in Tarpeyo 4 mg delayed-release oral capsules by Calliditas Therapeutics AB.*
FDA Label Image

Figure 1 (Tar02 0004 02)

Figure 1 (Tar02 0004 02)
A line graph depicting the percent change from baseline over 24 months comparing TARPEYO 16 mg treatment versus placebo. The x-axis represents time in months, divided into treatment and follow-up phases, while the y-axis shows percent change from baseline. TARPEYO shows a significant reduction over time, with error bars indicating variability, alongside a placebo group with minimal change.*
FDA Label Image

Figure 2 (Tar02 0004 03)

Figure 2 (Tar02 0004 03)
A line graph comparing change from baseline in a measured variable (mL/min/1.73 m2) over 24 months between Tarpeyo 16 mg and placebo groups. The x-axis represents months, divided into treatment and follow-up phases. The y-axis shows change from baseline, with Tarpeyo showing a positive trend and placebo showing a decline. Confidence intervals and sample sizes are noted below the graph.*
FDA Label Image

Principal Display Panel (4 mg Bottle Label)

Principal Display Panel (4 mg Bottle Label)
Label for Tarpeyo (budesonide) delayed release capsules, 4 mg. The label states the product contains 120 capsules and is Rx only. It includes storage instructions to keep tightly closed and protect from moisture, with a recommended temperature range. The label shows NDC 81749-004-01 and identifies Calliditas Therapeutics AB in Stockholm, Sweden, as the manufacturer and distributor.*

* 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.