Flecainide Acetate NDC 65862-621

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-621Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0621Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
65862-621-01	65862062101	100 TABLET in 1 BOTTLE (65862-621-01)Marketed from Nov 3, 2017
65862-621-30	65862062130	30 TABLET in 1 BOTTLE (65862-621-30)Marketed from Nov 3, 2017
65862-621-99	65862062199	1000 TABLET in 1 BOTTLE (65862-621-99)Marketed from Nov 3, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Flecainide Acetate
Generic name (nonproprietary): flecainide acetate
Active ingredients: Flecainide acetate — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202821
Marketing start: Nov 3, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 65862-621_c100187f-d40e-4ffe-aab7-068a9f3bd7b9SPL ID c100187f-d40e-4ffe-aab7-068a9f3bd7b9SPL set ID 14e89448-3a18-42e3-8537-2589be1ef94eRxCUI 886662, 886666, 886671UNII M8U465Q1WQUPC 0365862622303, 0365862621306, 0365862623300
Pharmacologic class: Antiarrhythmic

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N465862062101 followed by a unit qualifier and the quantity

Package 65862-0621-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 9, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE In patients without structural heart disease, flecainide acetate tablets, USP are 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 acetate tablets, USP are 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. Use of…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202821

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202821
Product	Strength	Form · route	Labeler	Product NDC
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	Bryant Ranch Prepack	63629-7979
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	Bryant Ranch Prepack	63629-7982
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	Aurobindo Pharma Limited	65862-623
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	Aurobindo Pharma Limited	65862-622
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	A-S Medication Solutions	50090-5306
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	Bryant Ranch Prepack	71335-2172
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	Rising Pharma Holdings, Inc.	57237-063
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	Rising Pharma Holdings, Inc.	57237-064
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	Rising Pharma Holdings, Inc.	57237-065