Flecainide Acetate

Sold as Tambocor. Every FDA application for this active ingredient: 1 branded and 10 generic.

As of Nov 14, 2026, FDA lists 11 applications for Flecainide Acetate (sold as Tambocor), first approved Oct 31, 1985, with 0 new uses approved and 0 published complete response letters.

First approved: Oct 31, 1985
Applications: 11
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $49.1M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Flecainide Acetate	Part D	$49.1M	-8%	351,398

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

FLECAINIDE ACETATE 100 MG TAB: $0.174 per unitGeneric · -5% in a year
FLECAINIDE ACETATE 150 MG TAB: $0.281 per unitGeneric · -5% in a year
FLECAINIDE ACETATE 50 MG TAB: $0.107 per unitGeneric · -4% in a year

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

TambocorDrugs with a new additional indication and a new dosage for the treatment of tachyarrhythmia (paroxysmal atrial fibrillation/flutter, paroxysmal… · Eisai Co., Ltd. · May 13, 2010

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Flecainide in Idiopathic Premature Ventricular Contractions and Related CardiomyopathyPremature Ventricular Beats, Premature Ventricular Complexes · University of Athens	—	Recruiting	Apr 29, 2025
Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or TachycardiaPatent Foramen Ovale, Atrial Arrhythmia · Assistance Publique - Hôpitaux de Paris	Phase 3	Active, not recruiting	Jan 28, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 31, 1985	TambocorNDA 18830 · New molecular entity	Alvogen	3	Discontinued
Jul 31, 2001	Flecainide AcetateANDA 75442	Amneal Pharm	0	Marketed
Oct 28, 2002	Flecainide AcetateANDA 75882	Ani Pharms	1	Marketed
Oct 28, 2002	Flecainide AcetateANDA 76030	Ani Pharms	0	Discontinued
Jan 14, 2003	Flecainide AcetateANDA 76278	Hikma	2	Marketed
Mar 28, 2003	Flecainide AcetateANDA 76421	Sun Pharm Inds Ltd	0	Marketed
Jul 9, 2009	Flecainide AcetateANDA 79164	Chartwell	0	Discontinued
Nov 3, 2017	Flecainide AcetateANDA 202821	Aurobindo Pharma Ltd	0	Marketed
Sep 16, 2020	Flecainide AcetateANDA 210683	Regcon Holdings	0	Marketed
Sep 8, 2022	Flecainide AcetateANDA 215599	Yichang Humanwell	0	Marketed
Apr 22, 2026	Flecainide AcetateANDA 218093	Micro Labs	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA