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Active ingredient

Alendronate

36 finished FDA listings contain Alendronate as their only active ingredient; 2 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
ALENDRONATE SODIUM, ALENDRONIC ACID
Dosage forms
Solution, Tablet, Tablet, Effervescent
Routes
Oral
Manufacturers / labelers
18
Strengths listed
10 mg/1 · 35 mg/1 · 40 mg/1 · 5 mg/1 · 70 mg/1 · 70 mg/75ml · 91.37 mg/1
Brand names in FDA listings
Alendronate, Binosto, Fosamax

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 46041

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 020560ORGANON1995-09-291
ANDA 075710IMPAX LABS INC2008-02-065
ANDA 090124AUROBINDO PHARMA2008-08-0413
ANDA 076768CIPLA2008-08-0410
ANDA 090258HANGZHOU BINJIANG2009-09-244
NDA 202344RADIUS2012-03-121
ANDA 090520HIKMA2013-02-251
ANDA 214512NOVITIUM PHARMA2023-05-111

Official labeling on DailyMed

Showing the 12 most recent of 22 labels.

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