Flecainide Acetate NDC 0054-0011

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0011Add 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
0054-0011-20	00054001120	100 BLISTER PACK in 1 CARTON (0054-0011-20) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 14, 2003
0054-0011-21	00054001121	60 TABLET in 1 BOTTLE (0054-0011-21)Marketed from Jan 14, 2003
0054-0011-25	00054001125	100 TABLET in 1 BOTTLE (0054-0011-25)Marketed from Jan 14, 2003

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076278
Marketing start: Jan 14, 2003
Listing expires: Dec 31, 2026
Identifiers: Product ID 0054-0011_e34a6adf-8794-426e-9e43-11060803a90dSPL ID e34a6adf-8794-426e-9e43-11060803a90dSPL set ID 4f6b78d4-8ac8-464b-bb78-ee70cbc97898RxCUI 886662, 886666, 886671UNII M8U465Q1WQUPC 0300540011215
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

N400054001120 followed by a unit qualifier and the quantity

Package 00054-0011-20. 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 Dec 4, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE In patients without structural heart disease, flecainide acetate 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 acetate 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 acetate for th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076278

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

FDA NDC Directory listings under ANDA 076278
Product	Strength	Form · route	Labeler	Product NDC
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0012
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0010