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Active ingredient

Sotalol

80 finished FDA listings contain Sotalol as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
SOTALOL HYDROCHLORIDE
Dosage forms
Injection, Solution, Tablet
Routes
Intravenous, Oral
Manufacturers / labelers
21
Strengths listed
120 mg/1 · 15 mg/ml · 160 mg/1 · 240 mg/1 · 5 mg/ml · 80 mg/1
Brand names in FDA listings
Betapace, Betapace Af, Sotalol, Sotalol Hydrochloride Af, Sotylize

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 9947

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 019865LEGACY1992-10-306
ANDA 075429TEVA2000-05-016
ANDA 075500AIPING PHARM INC2001-04-278
ANDA 076140APOTEX2002-09-2618
ANDA 076214APOTEX2003-08-274
ANDA 075563OXFORD PHARMS2003-11-0720
ANDA 077070EPIC PHARMA LLC2005-11-043
ANDA 077616AUROBINDO PHARMA USA2007-02-073
NDA 022306ALTATHERA PHARMS LLC2009-07-021
NDA 205108AZURITY2014-10-221
ANDA 207428REGCON HOLDINGS2016-10-217
ANDA 207429REGCON HOLDINGS2018-11-023

Official labeling on DailyMed

Showing the 12 most recent of 46 labels.

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