Prescription medicine

Flecainide First approved as Tambocor

Flecainide (Tambocor) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 15 generic labelers, and pharmacies paid $0.171 per flecainide acetate 100 mg tablet in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the flecainide FDA label on DailyMed (effective June 11, 2026, Amneal Pharmaceuticals of New York LLC); the NDA 18830 record on Drugs@FDA; every flecainide label on DailyMed.

Highlights of the record

FDA label of June 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
In patients without structural heart disease, flecainide is indicated for the prevention of - paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms - paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.

Forms and strengths

50 mg
100 mg
150 mg

Tablet.

On the market

Earliest approval on file: October 31, 1985 Tambocor, Alvogen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 10 first July 31, 2001; 8 with a marketed status in Drugs@FDA
Labelers listed (NDC): 15 of which 15 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): $0.171 per tablet Flecainide acetate 100 mg tablet
Shortage (FDA): No current entry
Recalls by its makers (FDA): 2 since 2013 0 Class I among all firms' recalls; latest July 2, 2013
FAERS reports: 5,246 through July 30, 2026

What is flecainide used for?

From the label: indications and usage
In patients without structural heart disease, flecainide is indicated for the prevention of - paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms - paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. Flecainide is also indicated for the prevention of - documented ventricular arrhythmias, such as sustained ventricular tachycardia ( sustained VT), that in the judgment of the physician, are life-threatening. […]

FDA pharmacologic class: Antiarrhythmic.

Source: FDA drug label (Flecainide Acetate), Amneal Pharmaceuticals of New York LLC, effective June 11, 2026 (SPL set ee9595d5-08a1-4529-9215-ddc3c7f929c4), via openFDA; the full label on DailyMed

Is there a generic for flecainide (Tambocor)?

The FDA approved the first generic flecainide on July 31, 2001. 10 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists flecainide from 15 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1985 earliest approval on file
2001 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for flecainide (Tambocor)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.171 per Flecainide acetate 100 mg tablet, down 4% from $0.177 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Flecainide acetate 50 mg tablet (generic)

$0.126

$0.0874

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Flecainide acetate 100 mg tablet	Generic	$0.171 per tablet	$5.14	-4%
Flecainide acetate 150 mg tablet	Generic	$0.269 per tablet	$8.07	-13%
Flecainide acetate 50 mg tablet	Generic	$0.108 per tablet	$3.25	-1%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has flecainide been recalled?

The FDA's Enforcement Report lists 2 recalls naming flecainide since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
July 2, 2013	Class II	Aidapak Services, LLC	Labeling:Label Mixup; FLECAINIDE ACETATE Tablet, 50 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD46419_7 …
July 2, 2013	Class II	Aidapak Services, LLC	Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the following drug: COLESTIPOL HCL MICRONIZED, Tablet, 1 g, NDC …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the flecainide label say about other medicines?

The flecainide label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 40 other medicines name flecainide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Digoxin	warnings	Concomitant negative chronotropic therapy such as digoxin or beta-blockers may lower the risk of this complication.

Other labels that name flecainide

Check flecainide against other medicines

What do FAERS reports show for flecainide?

The FDA Adverse Event Reporting System holds 5,246 reports that list flecainide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 446 are coded as a death and 2,101 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Atrial Fibrillation (a use or a product term, not a reaction)350
Fatigue (named in the label)287
Dyspnoea (named in the label)283
Dizziness (named in the label)270
Nausea (named in the label)250
Drug Ineffective (a use or a product term, not a reaction)227
Headache (named in the label)224
Diarrhoea (named in the label)216

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Alternatives to flecainide: medicines labeled for the same conditions
Other antiarrhythmics: the pharmacologic class, with prices and generics
Flecainide side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other