Source: FDA, National Drug Code (US) Revision Year: 2016
Enablex is an extended-release tablet for oral administration which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.
Chemically, darifenacin hydrobromide is (S)2{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide hydrobromide. The empirical formula of darifenacin hydrobromide is C28H30N2O2•HBr.
The structural formula is:
Darifenacin hydrobromide is a white to almost white, crystalline powder, with a molecular weight of 507.5.
Enablex is a once-a-day extended-release tablet and contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, polyethylene glycol, talc, titanium dioxide. The 15 mg tablet also contains ferric oxide red and ferric oxide yellow.
| Dosage Forms and Strengths |
|---|
|
Enablex extended-release tablets 7.5 mg are round, shallow, bi-convex, white-colored tablets, and are identified with “DF” on one side and “7.5” on the reverse. Enablex extended-release tablets 15 mg are round, shallow, bi-convex, light peach-colored tablets, and are identified with “DF” on one side and “15” on the reverse. |
| How Supplied |
|---|
|
Enablex, 7.5 mg are round, shallow, bi-convex, white-colored tablets, and are identified with “DF” on one side and “7.5” on the reverse. Bottle of 30 – NDC 0430-0170-15 Enablex, 15 mg are round, shallow, bi-convex, light peach-colored tablets, and are identified with “DF” on one side and “15” on the reverse. Bottle of 30 – NDC 0430-0171-15 Distributed by: Allergan USA, Inc., Irvine, CA 92612 |
| Drug | Countries | |
|---|---|---|
| ENABLEX | Brazil, Canada, Ecuador, Hong Kong, New Zealand, United States, South Africa |
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