Source: FDA, National Drug Code (US) Revision Year: 2021
ZORVOLEX (diclofenac) capsules are a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 18 mg and 35 mg for oral administration. The chemical name is 2-[(2, 6-dichlorophenyl) amino] benzeneacetic acid. The molecular weight is 296.15. Its molecular formula is C14H11C12NO2, and it has the following chemical structure.
Diclofenac acid is a white to slight yellowish crystalline powder. Diclofenac acid has a pKa of 4.18 and a logP of 3.03. It is practically insoluble in water and sparingly soluble in ethanol.
The inactive ingredients in ZORVOLEX include a combination of lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2, FDA/E172 Yellow Iron Oxide and FDA/E172 Black Iron Oxide. The imprinting on the gelatin capsules is white edible ink. The 18 mg capsules have a blue body imprinted with IP-203 and light green cap imprinted with 18 mg in white ink. The 35 mg capsules have a blue body imprinted with IP-204 and green cap imprinted with 35 mg in white ink.
| Dosage Forms and Strengths |
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ZORVOLEX (diclofenac) capsules: 18 mg – blue body and light green cap (imprinted IP-203 on the body and 18 mg on the cap in white ink). ZORVOLEX (diclofenac) capsules: 35 mg – blue body and green cap (imprinted IP-204 on the body and 35 mg on the cap in white ink). |
| How Supplied |
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ZORVOLEX (diclofenac) capsules are supplied as:
Manufactured (under license from iCeutica Pty Ltd.) for and Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087 |
| Drug | Countries | |
|---|---|---|
| ZORVOLEX | Ecuador, United States |
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