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Active ingredient

Amiodarone

72 finished FDA listings contain Amiodarone as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
AMIODARONE, AMIODARONE HYDROCHLORIDE
Dosage forms
Injection, Solution, Tablet
Routes
Intravenous, Oral
Manufacturers / labelers
33
Strengths listed
1.5 mg/ml · 1.8 mg/ml · 100 mg/1 · 150 mg/3ml · 200 mg/1 · 300 mg/1 · 400 mg/1 · 450 mg/9ml · 50 mg/ml · 900 mg/18ml
Brand names in FDA listings
Nexterone, Pacerone

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 703

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 075135UPSHER SMITH LABS1998-04-305
ANDA 075389DR REDDYS LABS SA2001-01-253
ANDA 075424TARO2001-03-305
ANDA 075761FRESENIUS KABI USA2002-10-155
ANDA 076217MYLAN INSTITUTIONAL2002-10-155
ANDA 076362TARO2002-11-292
ANDA 077069CHARTWELL RX2005-04-083
ANDA 077161GLAND PHARMA LTD2005-04-201
ANDA 077234HIKMA FARMACEUTICA2008-02-255
ANDA 079029ZYDUS PHARMS USA INC2008-09-167
ANDA 078578RUBICON RESEARCH2008-11-067
NDA 022325BAXTER HLTHCARE2008-12-244
ANDA 204742AUROBINDO PHARMA LTD2016-06-036
ANDA 204550EUGIA PHARMA2017-10-254
ANDA 213446UNICHEM2020-07-215
ANDA 218253ZHEJIANG POLY PHARM2024-09-115

Official labeling on DailyMed

Showing the 12 most recent of 51 labels.

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