ZORVOLEX is indicated for treatment of mild to moderate acute pain in adults.

Zorvolex Description

ZORVOLEX (diclofenac) capsules contain the active ingredient diclofenac which is a benzeneacetic acid based nonsteroidal anti-inflammatory drug (NSAID). ZORVOLEX is available as hard gelatin capsules of 18 mg and 35 mg for oral administration. The chemical name of diclofenac is 2-[(2, 6-dichlorophenyl) amino] benzeneacetic acid. The molecular weight is 296.15. Its molecular formula is C14H11Cl2NO2, and it has the following structural formula.

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.

Active Zorvolex Ingredients

  1. Diclofenac

Zorvolex NDC Codes

NDC Quantity Package
42211-0203-23 30 1 Bottle
42211-0203-29 90 1 Bottle
42211-0203-41 1 1 Carton
42211-0203-43 1 1 Carton
42211-0204-23 30 1 Bottle
42211-0204-29 90 1 Bottle
42211-0204-41 1 1 Carton
42211-0204-43 1 1 Carton

Zorvolex Structured Product Labels

SPL Manufacturer
dff10e66-a577-451d-ba75-1889458ca833 Iroko Pharmaceuticals LLC

Zorvolex Overview

Overall Rating
Medication Type
Approval Date
Oct 31, 2013
DEA Schedule
Not Classified

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