NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2523Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2523Add 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 NDC11-digit (billing)PackageCopy
71335-2523-1713352523017133525230130 TABLET in 1 BOTTLE (71335-2523-1)Marketed from Nov 25, 2024
71335-2523-2713352523027133525230290 TABLET in 1 BOTTLE (71335-2523-2)Marketed from Nov 25, 2024
71335-2523-3713352523037133525230360 TABLET in 1 BOTTLE (71335-2523-3)Marketed from Nov 25, 2024
71335-2523-47133525230471335252304180 TABLET in 1 BOTTLE (71335-2523-4)Marketed from Nov 25, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 150 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215599
Marketing start
Listing expires
Identifiers
Product ID 71335-2523_b840330d-c2a7-4b52-83f2-d935e0f3f00eSPL ID b840330d-c2a7-4b52-83f2-d935e0f3f00eSPL set ID b821ec16-93ff-4569-9fbb-4f3842c58becRxCUI 886671UNII M8U465Q1WQ
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

N471335252301 followed by a unit qualifier and the quantity

Package 71335-2523-01. 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 . 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 Fle…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2523

What is NDC 71335-2523?
71335-2523 is the product NDC for Flecainide Acetate, Flecainide acetate 150 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 4 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Flecainide AcetateFlecainide acetate 100 mg/1TabletOralBryant Ranch Prepack71335-257771335-2577-0171335-2577-0271335-2577-03+2 more
Flecainide AcetateFlecainide acetate 150 mg/1TabletOralBryant Ranch Prepack71335-265571335-2655-0171335-2655-0271335-2655-03+1 more
Flecainide AcetateFlecainide acetate 100 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-38372789-0383-0172789-0383-6072789-0383-93
Flecainide AcetateFlecainide acetate 150 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-38472789-0384-0172789-0384-6072789-0384-93
Flecainide AcetateFlecainide acetate 50 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-38572789-0385-0172789-0385-6072789-0385-93
Flecainide AcetateFlecainide acetate 50 mg/1TabletOralUNICHEM PHARMACEUTICALS (USA), INC.76385-14576385-0145-0176385-0145-60
Flecainide AcetateFlecainide acetate 100 mg/1TabletOralUNICHEM PHARMACEUTICALS (USA), INC.76385-14676385-0146-0176385-0146-60
Flecainide AcetateFlecainide acetate 150 mg/1TabletOralUNICHEM PHARMACEUTICALS (USA), INC.76385-14776385-0147-0176385-0147-60
Flecainide AcetateFlecainide acetate 50 mg/1TabletOralEpic Pharma, LLC42806-81742806-0817-01
Flecainide AcetateFlecainide acetate 100 mg/1TabletOralEpic Pharma, LLC42806-81842806-0818-01

All 56 Flecainide Acetate NDCs

Other NDCs under ANDA 215599

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

FDA NDC Directory listings under ANDA 215599
ProductStrengthForm · routeLabelerProduct NDC
Flecainide AcetateFlecainide acetate 50 mg/1TabletOralEpic Pharma, LLC42806-817
Flecainide AcetateFlecainide acetate 100 mg/1TabletOralEpic Pharma, LLC42806-818
Flecainide AcetateFlecainide acetate 150 mg/1TabletOralEpic Pharma, LLC42806-819
Flecainide AcetateFlecainide acetate 50 mg/1TabletOralBryant Ranch Prepack71335-2995
Flecainide AcetateFlecainide acetate 100 mg/1TabletOralBryant Ranch Prepack71335-3063

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