Source: FDA, National Drug Code (US) Revision Year: 2020
The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22.
The chemical structure is:
The drug substance is a white to off-white non-hygroscopic powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone.
DALIRESP is supplied as white to off-white, round tablets, embossed with “D” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast.
Each tablet of DALIRESP for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, povidone, and magnesium stearate.
| Dosage Forms and Strengths |
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| How Supplied |
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DALIRESP 250 mcg is supplied as white to off-white, round tablets, embossed with “D” on one side and “250” on the other side. DALIRESP 250 mcg tablets are available: Blister pack 28: NDC 0310-0088-28 DALIRESP 500 mcg is supplied as white to off-white, round tablets, embossed with “D” on one side and “500” on the other side. DALIRESP 500 mcg tablets are available: Bottles of 30: NDC 0310-0095-30 Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 |
| Drug | Countries | |
|---|---|---|
| DALIRESP | Estonia, Lithuania, United States |
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