DESCRIPTION
id: dc0c3375-7acb-455b-8933-cfaac1afd55f
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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 molecular formula is, C20H28N2O5●C4H4O4, and its structural formula is:
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 angiotensin converting enzyme inhibitor.
Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: hypromellose, anhydrous lactose, corn starch, stearic acid and talc. The 10 mg and 20 mg tablets also contain iron oxides.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
id: a8dd0b6e-a854-47e0-b69b-6fe9e42f6e09
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
DRUG: Enalapril Maleate
GENERIC: Enalapril Maleate
DOSAGE: Tablets
ADMINSTRATION: Oral
NDC: 64679-923-02
STRENGTH: 2.5 mg
COLOR: White
SHAPE: Round (flat-faced beveled edged)
SCORE: Score
SIZE: 6 mm
IMPRINT: W923
QTY: 100 Tablets
DRUG: Enalapril Maleate
GENERIC: Enalapril Maleate
DOSAGE: Tablets
ADMINSTRATION: Oral
NDC: 64679-924-02
STRENGTH: 5 mg
COLOR: White
SHAPE: Round (flat-faced beveled edged)
SCORE: Score
SIZE: 8 mm
IMPRINT: W924
QTY: 100 Tablets
DRUG: Enalapril Maleate
GENERIC: Enalapril Maleate
DOSAGE: Tablets
ADMINSTRATION: Oral
NDC: 64679-925-03
STRENGTH: 10 mg
COLOR: Orange
SHAPE: Round (flat-faced beveled edged)
SCORE: No Score
SIZE: 8 mm
IMPRINT: W925
QTY: 1000 Tablets
DRUG: Enalapril Maleate
GENERIC: Enalapril Maleate
DOSAGE: Tablets
ADMINSTRATION: Oral
NDC: 64679-926-03
STRENGTH: 20 mg
COLOR: Brown (Light Beige)
SHAPE: Round (flat-faced beveled edged)
SCORE: No Score
SIZE: 8 mm
IMPRINT: W926
QTY: 1000 Tablets