Prescription drug · ANDA
Flecainide Acetate NDC 76385-145
Flecainide acetate 50 mg/1 · Tablet · Oral · UNICHEM PHARMACEUTICALS (USA), INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76385-145-01 | 76385014501 | 100 TABLET in 1 BOTTLE (76385-145-01)Marketed from Jan 11, 2024 | |
| 76385-145-60 | 76385014560 | 60 TABLET in 1 BOTTLE (76385-145-60)Marketed from Jan 11, 2024 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210683
- Marketing start
- Listing expires
- Identifiers
- Product ID 76385-145_6e5f6cbe-c7eb-4168-b02b-119798e895d6SPL ID 6e5f6cbe-c7eb-4168-b02b-119798e895d6SPL set ID 5b33e96a-8336-46c4-aac7-4a6c0039cc80RxCUI 886662, 886666, 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
N476385014501followed by a unit qualifier and the quantityPackage 76385-0145-01. 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 f…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210683
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 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2577 |
| Flecainide Acetate | Flecainide acetate 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2655 |
| Flecainide Acetate | Flecainide acetate 100 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-146 |
| Flecainide Acetate | Flecainide acetate 150 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-147 |
| Flecainide Acetate | Flecainide acetate 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-385 |
| Flecainide Acetate | Flecainide acetate 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-383 |
| Flecainide Acetate | Flecainide acetate 150 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-384 |