VASOTEC Tablet Ref.[10618] Active ingredients: Enalapril

Source: FDA, National Drug Code (US)  Revision Year: 2018 

Product description

VASOTEC (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 empirical formula is C20H28N2O5â€ĒC4H4O4, 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: lactose, magnesium stearate, sodium bicarbonate, and starch. The 10 mg and 20 mg tablets also contain iron oxides.

How Supplied
VASOTEC (Enalapril Maleate) Tablets
NDC NumberStrengthQuantityDescription
0187-0140-30 2.5 mg Bottles of 30
(with desiccant)
White, oval shaped tablet imprinted with “VASO 2.5” and scored on one side and scored on the other.
0187-0140-90 Bottles of 90
(with desiccant)
0187-0141-30 5 mg Bottles of 30
(with desiccant)
White, rounded triangle shaped tablet imprinted with “VASO 5” on one side and scored on the other.
0187-0141-90 Bottles of 90
(with desiccant)
0187-0142-30 10 mg Bottles of 30
(with desiccant)
Rust red, rounded triangle shaped tablet imprinted with “VASO 10” on one side and scored on the other.
0187-0142-90 Bottles of 90
(with desiccant)
0187-0142-10 Bottles of 1,000
(with desiccant)
0187-0143-30 20 mg Bottles of 30
(with desiccant)
Peach, rounded triangle shaped tablet imprinted with “VASO 20” on one side and scored on the other.
0187-0143-90 Bottles of 90
(with desiccant)
0187-0143-10 Bottles of 1,000
(with desiccant)

Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA

Manufactured by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada

Drugs

Drug Countries
VASOTEC Canada, United States

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