Source: FDA, National Drug Code (US) Revision Year: 2020
ACCUPRIL is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.
Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]2[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5∙HCl and its structural formula is:
Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents.
ACCUPRIL tablets contain 5 mg (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each tablet also contains candelilla wax, crospovidone, gelatin, lactose, magnesium carbonate, magnesium stearate, synthetic red iron oxide, and titanium dioxide.
| How Supplied |
|---|
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ACCUPRIL tablets are supplied as follows: 5-mg tablets: brown, film-coated, elliptical scored tablets, coded “PD 527” on one side and “5” on the other. NDC 0071-0527-23 bottles of 90 tablets 10-mg tablets: brown, film-coated, triangular tablets, coded “PD 530” on one side and “10” on the other. NDC 0071-0530-23 bottles of 90 tablets 20-mg tablets: brown, film-coated, round tablets, coded “PD 532” on one side and “20” on the other. NDC 0071-0532-23 bottles of 90 tablets 40-mg tablets: brown, film-coated, elliptical tablets, coded “PD 535” on one side and “40” on the other. NDC 0071-0535-23 bottles of 90 tablets Dispense in well-closed containers as defined in the USP. |
| Drug | Countries | |
|---|---|---|
| ACCUPRIL | Australia, Canada, United States, South Africa |
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