What is NDC 65162-642?

65162-642 is the product NDC for Flecainide Acetate, Flecainide acetate 100 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Flecainide Acetate?

55 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Flecainide Acetate NDC 65162-642 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-642Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0642Add 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	Copy
65162-642-10	6516206421065162064210	100 TABLET in 1 BOTTLE (65162-642-10)Marketed from Dec 1, 2009
65162-642-11	6516206421165162064211	1000 TABLET in 1 BOTTLE (65162-642-11)Marketed from Dec 1, 2009

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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075442
Marketing start: Dec 1, 2009
Listing expires: Dec 31, 2027
Identifiers: Product ID 65162-642_2d832566-4d97-4605-a207-04c4a0214213SPL ID 2d832566-4d97-4605-a207-04c4a0214213SPL set ID d462d58e-fc3c-4c92-a210-e135eb1f4b77RxCUI 886662, 886666, 886671UNII M8U465Q1WQUPC 0365162641103, 0365162643107, 0365162642100
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

N465162064210 followed by a unit qualifier and the quantity

Package 65162-0642-10. 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 Oct 25, 2024.

Indications (excerpt 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. Use of flecainide for the treatment of sustained…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-642

What is NDC 65162-642?: 65162-642 is the product NDC for Flecainide Acetate, Flecainide acetate 100 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Flecainide Acetate.
What is the active ingredient?: Flecainide acetate.
Who is the labeler?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Flecainide Acetate?: 55 other product NDCs are listed under this name. See all Flecainide Acetate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Flecainide Acetate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-2577	71335-2577-0171335-2577-0271335-2577-03+2 more
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	Bryant Ranch Prepack	71335-2655	71335-2655-0171335-2655-0271335-2655-03+1 more
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-383	72789-0383-0172789-0383-6072789-0383-93
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-384	72789-0384-0172789-0384-6072789-0384-93
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-385	72789-0385-0172789-0385-6072789-0385-93
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-145	76385-0145-0176385-0145-60
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-146	76385-0146-0176385-0146-60
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-147	76385-0147-0176385-0147-60
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	Epic Pharma, LLC	42806-817	42806-0817-01
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	Epic Pharma, LLC	42806-818	42806-0818-01

All 56 Flecainide Acetate NDCs

Other NDCs under ANDA 075442

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

FDA NDC Directory listings under ANDA 075442
Product	Strength	Form · route	Labeler	Product NDC
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	A-S Medication Solutions	50090-6810
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	AvPAK	50268-320
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	AvPAK	50268-321
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-641
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-642
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-643
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-641
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-643