Mesalamine Capsule, Extended Release
Product Images NDC 50742-371

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Mesalamine (NDC 50742-371). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ingenus Pharmaceuticals, 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

Bottle (Bottle)

Label for Mesalamine Extended-Release Capsules, USP, 0.375 g strength, oral dosage form. The label shows the product contains 120 capsules and is manufactured for Ingenus Pharmaceuticals, LLC. It includes storage instructions, a barcode, and lot, expiration, and serial number placeholders. The label emphasizes the 0.375 g dosage and Rx only.*

FDA Label Image

Mesalamine Structural Formula (Image 02)

Chemical structure of mesalamine showing a benzene ring with amino, hydroxyl, and carboxylic acid functional groups attached.*

FDA Label Image

Logo (Logo)

FDA Label Image

Table1 (Table1)

Table presenting common adverse reactions in clinical trials of adults with ulcerative colitis comparing Mesalamine Extended-Release Capsules 1.5 g once daily (N=367) versus placebo (N=185). Adverse reactions listed include headache, diarrhea, upper abdominal pain, nausea, and nasopharyngitis, with corresponding percentages for each group.*

FDA Label Image

Table2 (Table2)

A data table showing single and multiple dose mean plasma pharmacokinetic parameters (with standard deviation) for Mesalamine (5-ASA) and N-Ac-5-ASA after administration of 1.5 g Mesalamine Extended-Release Capsules in healthy subjects. Parameters include AUC0-24, AUC0-inf, Cmax, Tmax, and half-life (t1/2) for two groups of 24 subjects each.*

* 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.