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Active ingredient

Simvastatin

159 finished FDA listings contain Simvastatin as their only active ingredient; 28 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
SIMVASTATIN
Dosage forms
Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
28
Strengths listed
10 mg/1 · 20 mg/1 · 40 mg/1 · 5 mg/1 · 80 mg/1
Brand names in FDA listings
Zocor

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 36567

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 019766ORGANON1991-12-233
ANDA 077691AUROBINDO PHARMA2006-12-2031
ANDA 078034BIOCON PHARMA2006-12-2028
ANDA 078103LUPIN2007-05-1151
ANDA 078155ACCORD HLTHCARE2008-02-2627
ANDA 200895HETERO LABS LTD III2014-11-2515
ANDA 211394YILING2024-11-274

Official labeling on DailyMed

Showing the 12 most recent of 111 labels.

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