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Active ingredient

Zoledronic Acid

36 finished FDA listings contain Zoledronic Acid as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ZOLEDRONIC ACID, ZOLEDRONIC ACID ANHYDROUS
Dosage forms
Injection, Injection, Solution, Injection, Solution, Concentrate
Routes
Intravenous
Manufacturers / labelers
22
Strengths listed
.04 mg/ml · .05 mg/ml · 4 mg/100ml · 4 mg/5ml · 5 mg/100ml
Brand names in FDA listings
Reclast

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 77655

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 021817SANDOZ2007-04-161
ANDA 091186DR REDDYS LABS LTD2013-03-043
ANDA 202650MYLAN LABS LTD2013-03-041
ANDA 201783AVET LIFESCIENCES2013-03-124
ANDA 091363DR REDDYS LABS LTD2013-03-292
ANDA 202182HIKMA FARMACEUTICA2013-06-031
NDA 203231INFORLIFE2013-08-022
ANDA 202930GLAND2013-08-053
ANDA 202828INFORLIFE2013-09-231
ANDA 202923USV2014-09-042
ANDA 204217GLAND2016-08-182
ANDA 207751EUGIA PHARMA2016-09-261
ANDA 205279ACCORD HLTHCARE2016-11-282
ANDA 203841MYLAN LABS LTD2017-02-141
ANDA 205254MYLAN LABS LTD2017-10-271
ANDA 209125EUGIA PHARMA2017-12-081
ANDA 207341BPI LABS2017-12-291
ANDA 205749GLAND2018-06-291
ANDA 204344DR REDDYS2018-11-191
ANDA 209578GLAND2019-08-083
ANDA 213371MEITHEAL2023-06-051
ANDA 219984GLAND2026-02-051

Official labeling on DailyMed

Showing the 12 most recent of 33 labels.

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