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Active ingredient

Prasugrel

21 finished FDA listings contain Prasugrel as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
PRASUGREL, PRASUGREL HYDROCHLORIDE
Dosage forms
Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
11
Strengths listed
10 mg/1 · 5 mg/1
Brand names in FDA listings
Effient

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 613391

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 022307COSETTE2009-07-102
ANDA 205927MYLAN2017-07-124
ANDA 205888AUROBINDO PHARMA2017-10-164
ANDA 205897PANACEA2017-10-165
ANDA 205987ACCORD HLTHCARE2018-02-022
ANDA 205913AMNEAL PHARMS2018-06-192
ANDA 213315UNICHEM2023-08-282

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.