Prescription drug · ANDA
Flecainide Acetate NDC 57237-065
Flecainide acetate 150 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-065-01 | 57237006501 | 100 TABLET in 1 BOTTLE (57237-065-01)Marketed from Jul 8, 2015 |
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
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202821
- Marketing start
- Listing expires
- Identifiers
- Product ID 57237-065_c6b596c3-30c8-4bf6-89f6-03026358a3c6SPL ID c6b596c3-30c8-4bf6-89f6-03026358a3c6SPL set ID e56335c1-5508-4136-bd2e-18385623e497RxCUI 886662, 886666, 886671UNII M8U465Q1WQUPC 0357237064016, 0357237063019, 0357237065013
- 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
N457237006501followed by a unit qualifier and the quantityPackage 57237-0065-01. 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202821
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 | 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 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-621 |
| 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 |