ALTACE Capsule Ref.[10535] Active ingredients: Ramipril

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°–112°C.

The CAS Registry Number is 87333-19-5. Ramipril’s chemical name is (2S,3aS,6aS)1[(S)N-[(S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1-ethyl ester.

The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains yellow iron oxide, the 2.5 mg capsule shell contains D&C yellow #10 and FD&C red #40, the 5 mg capsule shell contains FD&C blue #1 and FD&C red #40, and the 10 mg capsule shell contains FD&C blue #1.

The structural formula for ramipril is:

Its empirical formula is C23H32N2O5 and its molecular weight is 416.5.

Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.

Dosage Forms and Strengths

ALTACE (ramipril) is supplied as hard gelatin capsules containing 1.25 mg, 2.5 mg, 5 mg, and 10 mg of ramipril.

How Supplied

ALTACE is available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules. Descriptions of ALTACE capsules are summarized below.

Capsule Strength Capsule Color Package Configuration NDC#
1.25 mg Yellow Bottle of 100 61570-110-01
2.5 mg Orange Bottle of 100 61570-111-01
5 mg Red Bottle of 100 61570-112-01
10 mg Process Blue Bottle of 100 61570-120-01

Drugs

Drug Countries
ALTACE Canada, United States

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