Prescription drug · ANDA
Flecainide Acetate NDC 53746-643
Flecainide acetate 150 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53746-643-01 | 53746064301 | 100 TABLET in 1 BOTTLE (53746-643-01)Marketed from Dec 1, 2009 | |
| 53746-643-10 | 53746064310 | 1000 TABLET in 1 BOTTLE (53746-643-10)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 — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075442
- Marketing start
- Listing expires
- Identifiers
- Product ID 53746-643_e9e0eab5-efc5-4bac-8d46-0bce60b2fcc5SPL ID e9e0eab5-efc5-4bac-8d46-0bce60b2fcc5SPL set ID ee9595d5-08a1-4529-9215-ddc3c7f929c4RxCUI 886662, 886666, 886671UNII M8U465Q1WQUPC 0353746643018
- 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
N453746064301followed by a unit qualifier and the quantityPackage 53746-0643-01. 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 .
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.
Other NDCs under ANDA 075442
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 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 100 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-642 |
| 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 |
| Flecainide Acetate | Flecainide acetate 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6810 |
| Flecainide Acetate | Flecainide acetate 100 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-642 |
| Flecainide Acetate | Flecainide acetate 50 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-641 |