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Active ingredient

Risedronate

27 finished FDA listings contain Risedronate as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
RISEDRONATE SODIUM, RISEDRONATE SODIUM HEMI-PENTAHYDRATE, RISEDRONATE SODIUM HEMIPENTAHYDRATE, RISEDRONATE SODIUM MONOHYDRATE
Dosage forms
Tablet, Delayed Release, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
8
Strengths listed
150 mg/1 · 30 mg/1 · 35 mg/1 · 5 mg/1 · 75 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 73056

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 077132TEVA PHARMS USA2007-10-053
ANDA 090877APOTEX2014-06-104
ANDA 090886SUN PHARM2014-06-105
ANDA 200296AUROBINDO PHARMA LTD2015-11-303
ANDA 203533MACLEODS PHARMS2015-12-093
ANDA 206768AUROBINDO PHARMA2016-10-211
ANDA 207516HANGZHOU BINJIANG2019-02-151
ANDA 203925SUN PHARM2019-07-091

Official labeling on DailyMed

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