Quick answers
- What is Flecainide acetate used for?
- The FDA-approved label (Flecainide Acetate, Amneal Pharmaceuticals of New York LLC, June 11, 2026) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Flecainide acetate have a boxed warning?
- The label we quote has no boxed warning, but 30 of 35 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Flecainide acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Flecainide acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Flecainide acetate?
- 15 companies list prescription products of Flecainide acetate in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Epic Pharma, LLC.
What Flecainide acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 …
— FDA label: Flecainide Acetate, Amneal Pharmaceuticals of New York LLC, effective June 11, 2026. Read the full label on DailyMed →
The FDA has 35 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
30 of 35 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 56 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| flecainide acetate 100 mg tablet | Generic | $0.1739 per tablet |
| flecainide acetate 150 mg tablet | Generic | $0.2808 per tablet |
| flecainide acetate 50 mg tablet | Generic | $0.1074 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack16 products
- A-S Medication Solutions4 products
- Epic Pharma, LLC3 products
- Rising Pharma Holdings, Inc.3 products
- Chartwell RX, LLC3 products
- Hikma Pharmaceuticals USA Inc.3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Golden State Medical Supply, Inc.3 products
- Amneal Pharmaceuticals LLC3 products
- Aurobindo Pharma Limited3 products
- Unichem Pharmaceuticals (USA), Inc.3 products
- ANI Pharmaceuticals, Inc.3 products
- Amneal Pharmaceuticals of New York LLC3 products
- AvPAK2 products
- Proficient Rx LP1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (7)
- ANDA075442Amneal Pharm · July 31, 2001
- ANDA075882Ani Pharms · October 28, 2002
- ANDA076278Hikma · January 14, 2003
- ANDA079164Chartwell · July 9, 2009
- ANDA202821Aurobindo Pharma Ltd · November 3, 2017
- ANDA210683Regcon Holdings · September 16, 2020
- ANDA215599Yichang Humanwell · September 8, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 886662, 886666, 886671 |
|---|---|
| SPL set ID of the quoted label | ee9595d5-08a1-4529-9215-ddc3c7f929c4 |
| FDA labels (SPL) | 35 |
| FDA applications | 7 ANDA |
| Active ingredients (FDA) | FLECAINIDE ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Flecainide Acetate, Amneal Pharmaceuticals of New York LLC, effective June 11, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →