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Active ingredient

Pitavastatin

42 finished FDA listings contain Pitavastatin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PITAVASTATIN, PITAVASTATIN CALCIUM, PITAVASTATIN MAGNESIUM
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
14
Strengths listed
1 mg/1 · 1.045 mg/1 · 2 mg/1 · 2.09 mg/1 · 4 mg/1 · 4.18 mg/1
Brand names in FDA listings
Livalo, Pitavastatin, Pitavastatin Calcium, Zypitamag

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 861634

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 022363KOWA CO2009-08-033
ANDA 206015AUROBINDO PHARMA2016-12-203
ANDA 205932ORIENT PHARMA CO LTD2017-02-036
ANDA 205955SAWAI USA2017-02-036
NDA 208379MEDICURE2017-07-144
ANDA 206070MYLAN2019-04-043
ANDA 206047ZYDUS PHARMS2023-02-226
ANDA 205977HETERO LABS LTD V2024-04-308
ANDA 205961AMNEAL PHARMS NY2024-08-203

Official labeling on DailyMed

Showing the 12 most recent of 15 labels.

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