Skip to content
LookupMeds

Active ingredient

Raloxifene

23 finished FDA listings contain Raloxifene as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
RALOXIFENE HYDROCHLORIDE
Dosage forms
Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
18
Strengths listed
60 mg/1
Brand names in FDA listings
Evista, Raloxifene Hydrochloride

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 72143

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 020815LILLY1997-12-091
ANDA 078193TEVA PHARMS USA2014-03-042
ANDA 090842INVAGEN PHARMS2014-09-244
ANDA 204310AUROBINDO PHARMA2015-08-284
ANDA 204491GLENMARK PHARMS LTD2016-03-221
ANDA 208206AMNEAL PHARMS2016-04-082
ANDA 206384SCIEGEN PHARMS2016-10-125
ANDA 211324CADILA PHARMS LTD2020-08-184

Official labeling on DailyMed

Showing the 12 most recent of 23 labels.

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