EFFIENT Film-coated tablet Ref.[11126] Active ingredients: Prasugrel

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

Effient contains prasugrel, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP receptor. Effient is formulated as the hydrochloride salt, a racemate, which is chemically designated as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride. Prasugrel hydrochloride has the empirical formula C20H20FNO3S•HCl representing a molecular weight of 409.90.

The chemical structure of prasugrel hydrochloride is:

Prasugrel hydrochloride is a white to practically white solid. It is soluble at pH 2, slightly soluble at pH 3 to 4, and practically insoluble at pH 6 to 7.5. It also dissolves freely in methanol and is slightly soluble in 1- and 2-propanol and acetone. It is practically insoluble in diethyl ether and ethyl acetate.

Effient is available for oral administration as 5-mg or 10-mg elongated hexagonal, film-coated, non-scored tablets, debossed on each side. Each yellow 5-mg tablet is manufactured with 5.49 mg prasugrel hydrochloride, equivalent to 5-mg prasugrel and each beige 10-mg tablet with 10.98 mg prasugrel hydrochloride, equivalent to 10-mg of prasugrel.

Other ingredients include mannitol, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, sucrose stearate, and glyceryl behenate. The color coatings contain lactose, hypromellose, titanium dioxide, triacetin, iron oxide yellow, and iron oxide red (only in Effient 10-mg tablet).

Dosage Forms and Strengths

Effient 5-mg is available as a yellow, elongated hexagonal, film-coated, non-scored tablet debossed with “5121” on one side and 3 parallel arched lines followed by a “5” on the other side.

Effient 10-mg is available as a beige, elongated hexagonal, film-coated, non-scored tablet debossed with “5123” on one side and 3 parallel arched lines followed by a “10” on the other side.

How Supplied

Effient (prasugrel) is available as elongated hexagonal, film-coated, non-scored tablets in the following strengths, colors, imprints, and presentations:

FeaturesStrengths
5-mg10-mg
Tablet color yellow beige
Tablet imprint 5 10
Tablet imprint 5121 5123
Presentations and NDC Codes
Bottles of 30 0002-5121-30 0002-5123-30
Blisters ID*24 0002-5121-52 NA
Blisters ID*90 NA 0002-5123-77

* Identi Dose, unit dose medication, Lilly

Effient is a registered trademark of Eli Lilly and Company.

Manufactured by Eli Lilly and Company, Indianapolis, IN, 46285, USA

Marketed by Daiichi Sankyo, Inc. and Lilly USA, LLC

Drugs

Drug Countries
EFFIENT Brazil, New Zealand, Singapore, Turkey, United States

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