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Active ingredient

Flecainide

56 finished FDA listings contain Flecainide as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
FLECAINIDE ACETATE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
15
Strengths listed
100 mg/1 · 150 mg/1 · 50 mg/1
Brand names in FDA listings
Flecainide Acetate

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 4441

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 075442AMNEAL PHARM2001-07-319
ANDA 075882ANI PHARMS2002-10-2817
ANDA 076278HIKMA2003-01-143
ANDA 079164CHARTWELL2009-07-093
ANDA 202821AUROBINDO PHARMA LTD2017-11-0310
ANDA 210683REGCON HOLDINGS2020-09-168
ANDA 215599YICHANG HUMANWELL2022-09-086

Official labeling on DailyMed

Showing the 12 most recent of 35 labels.

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