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Active ingredient

Pravastatin

186 finished FDA listings contain Pravastatin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PRAVASTATIN SODIUM
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
37
Strengths listed
10 mg/1 · 20 mg/1 · 40 mg/1 · 80 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 42463

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
ANDA 076056AUROBINDO PHARMA USA2006-04-2423
ANDA 076714DR REDDYS LABS INC2006-10-234
ANDA 076341APOTEX2006-10-2362
ANDA 077987GLENMARK PHARMS LTD2007-05-1134
ANDA 077917CHARTWELL RX2008-01-089
ANDA 077793AUROBINDO PHARMA USA2008-01-152
ANDA 077491SENORES PHARMS2008-02-114
ANDA 207068ACCORD HLTHCARE2016-11-179
ANDA 203367AUROBINDO PHARMA2017-02-024
ANDA 209869BIOCON PHARMA2018-04-1335

Official labeling on DailyMed

Showing the 12 most recent of 119 labels.

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