Prescription drug · ANDA
Flecainide Acetate (Flecainide acetate tablet) NDC 82804-155
Flecainide acetate 50 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-155-30 | 8280401553082804015530 | 30 TABLET in 1 BOTTLE (82804-155-30)Marketed from Oct 3, 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 tablet
- Active ingredients
- Flecainide acetate — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075882
- Marketing start
- Listing expires
- Identifiers
- Product ID 82804-155_ee590951-cce8-4a1e-b3bd-ae0b610ebda9SPL ID ee590951-cce8-4a1e-b3bd-ae0b610ebda9SPL set ID ee590951-cce8-4a1e-b3bd-ae0b610ebda9RxCUI 886662UNII M8U465Q1WQUPC 0382804155309
- 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
N482804015530followed by a unit qualifier and the quantityPackage 82804-0155-30. 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.
About NDC 82804-155
- What is NDC 82804-155?
- 82804-155 is the product NDC for Flecainide Acetate (flecainide acetate tablet), Flecainide acetate 50 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Flecainide Acetate (Flecainide Acetate Tablet).
- What is the active ingredient?
- Flecainide acetate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. 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.
Related NDCs: other Flecainide Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Flecainide Acetate | Flecainide acetate 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2577 | 71335-2577-0171335-2577-0271335-2577-03+2 more |
| Flecainide Acetate | Flecainide acetate 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2655 | 71335-2655-0171335-2655-0271335-2655-03+1 more |
| Flecainide Acetate | Flecainide acetate 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-383 | 72789-0383-0172789-0383-6072789-0383-93 |
| Flecainide Acetate | Flecainide acetate 150 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-384 | 72789-0384-0172789-0384-6072789-0384-93 |
| Flecainide Acetate | Flecainide acetate 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-385 | 72789-0385-0172789-0385-6072789-0385-93 |
| Flecainide Acetate | Flecainide acetate 50 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-145 | 76385-0145-0176385-0145-60 |
| Flecainide Acetate | Flecainide acetate 100 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-146 | 76385-0146-0176385-0146-60 |
| Flecainide Acetate | Flecainide acetate 150 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-147 | 76385-0147-0176385-0147-60 |
| Flecainide Acetate | Flecainide acetate 50 mg/1 | TabletOral | Epic Pharma, LLC | 42806-817 | 42806-0817-01 |
| Flecainide Acetate | Flecainide acetate 100 mg/1 | TabletOral | Epic Pharma, LLC | 42806-818 | 42806-0818-01 |
Other NDCs under ANDA 075882
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 | A-S Medication Solutions | 50090-2968 |
| Flecainide Acetate | Flecainide acetate 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6035 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-018 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 100 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-019 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 150 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-020 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 50 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-380 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 100 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-381 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 150 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-382 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 100 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1945 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1946 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 150 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1981 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9184 |
| Flecainide Acetate | Flecainide acetate 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1487 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 50 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1760 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 100 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1761 |
| Flecainide Acetateflecainide acetate tablet | Flecainide acetate 150 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1762 |