Silodosin Capsule
Product Images NDC 82619-113

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Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Silodosin (NDC 82619-113). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Creekwood 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

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FDA Label Image

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FDA Label Image

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Change from Baseline in IPSS Total Score. The text mentions a significant difference in the IPSS Total Score with a p-value of less than 0.0001 between the placebo group and the group receiving Silodosin Capsules 8 mg over the course of 28 days. The analysis seems to involve the last observation carried forward method.*
FDA Label Image

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Change from Baseline in IPSS Total Score comparing Silodosin capsules 8 mg with the Placebo group on Day 357 was statistically significant (p<0.0001).*
FDA Label Image

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This text provides information about the change in maximum flow rate (Qmax) in milliliters per second (mL/sec) from baseline to day 84 in a clinical study comparing ArAeh placebo and Silodosin Capsules 8mg. The statistical significance is indicated with *p<0.05. The data is recorded on days 14, 28, and 84 (or last observation carried forward - LOCF).*
FDA Label Image

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This is a description of Silodosin capsules, with each capsule containing 4 mg of Silodosin. The recommended dosage is one capsule daily with a meal. The package is child-resistant and should be stored at 20° to 25°C. It is important to protect from light and moisture and dispense in a light-resistant container. The manufacturer is V-Ensure Pharma Technologies Pvt. Ltd. in India, and the distributor is Creekwood Pharmaceuticals LLC in Parsippany, NJ.*
FDA Label Image

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This is a description of Silodosin capsules, with each capsule containing Silodosin 8 mg. The usual dosage is one capsule daily with a meal. The packaging is child-resistant and should be stored between 20°C to 25°C. It is important to protect the capsules from light and moisture and keep them in a tight, light-resistant container. This medication is distributed by Creekwood Pharmaceuticals LLC in Parsippany, NJ, and manufactured by V-Ensure Pharma Technologies Pvt. Ltd. in Raigad, Maharashtra, India. The package includes 30 capsules and is for prescription use only.*
FDA Label Image

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This is a prescription-only medication called Silodosin in capsule form, with each capsule containing 8 mg of Silodosin. The usual dosage is one capsule daily with a meal. The packaging is child-resistant and should be stored between 20°C to 25°C. It should be protected from light and moisture and dispensed in a tight, light-resistant container. The medication is manufactured by V-Ensure Pharma Technologies Pvt. Ltd. in Raigad, Maharashtra, India, and distributed by Creekwood Pharmaceuticals LLC in Parsippany, NJ. The issue date on this information is 11/2023.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.