Drug Information for Enalapril Maleate Tablets, USP (Sandoz Inc.): DESCRIPTION

Enalapril Maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its structural formula is:

M.W. 492.53 C20H28N2O5 • C4H4O4

Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol.

Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensinconverting enzyme inhibitor.

Each tablet, for oral administration, contains 2.5 mg, 5 mg, 10 mg, or 20 mg of enalapril maleate. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, castor oil, magnesium stearate, and the coloring agents:

The 2.5 mg strength contains Yellow Iron Oxide

The 5 mg strength contains no dyes

The 10 mg strength contains Red Iron Oxide

The 20 mg strength contains Yellow and Red Iron Oxide.