LOTENSIN Tablet Ref.[10587] Active ingredients: Benazepril

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H1(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is

Its empirical formula is C24H28N2O5•HCl, and its molecular weight is 460.96.

Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor.

Lotensin is supplied as tablets containing 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, hydrogenated castor oil (10 mg and 20 mg tablets), hypromellose, iron oxides, lactose, magnesium stearate (40 mg tablets), microcrystalline cellulose, polysorbate 80, propylene glycol (40 mg tablets), starch, talc, and titanium dioxide.

Dosage Forms and Strengths

Tablets: 10 mg, 20 mg, and 40 mg.

  • Each 10 mg tablet is dark yellow with “10” on one side and “LOTENSIN” on the other
  • Each 20 mg tablet is pink with “20” on one side and “LOTENSIN” on the other
  • Each 40 mg tablet is dark rose with “40” on one side and “LOTENSIN” on the other
How Supplied

Lotensin is available as:

DoseColorEngravingBottle of 100
10 mg Dark Yellow Lotensin 10 NDC 30698-448-01
20 mg Pink Lotensin 20 NDC 30698-449-01
40 mg Dark Rose Lotensin 40 NDC 30698-450-01

Manufactured for and Distributed by: Validus Pharmaceuticals LLC, 119 Cherry Hill Road, Suite 310, Parsippany, NJ 07054

Drugs

Drug Countries
LOTENSIN Poland, United States
 
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