Prescription drug · ANDA
Flecainide Acetate NDC 0054-0010
Flecainide acetate 50 mg/1 · Tablet · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0010-20 | 0005400102000054001020 | 100 BLISTER PACK in 1 CARTON (0054-0010-20) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 14, 2003 | |
| 0054-0010-21 | 0005400102100054001021 | 60 TABLET in 1 BOTTLE (0054-0010-21)Marketed from Jan 14, 2003 | |
| 0054-0010-25 | 0005400102500054001025 | 100 TABLET in 1 BOTTLE (0054-0010-25)Marketed from Jan 14, 2003 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076278
- Marketing start
- Listing expires
- Identifiers
- Product ID 0054-0010_e34a6adf-8794-426e-9e43-11060803a90dSPL ID e34a6adf-8794-426e-9e43-11060803a90dSPL set ID 4f6b78d4-8ac8-464b-bb78-ee70cbc97898RxCUI 886662, 886666, 886671UNII M8U465Q1WQUPC 0300540011215
- 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
N400054001020followed by a unit qualifier and the quantityPackage 00054-0010-20. 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 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 acetate 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 acetate for th…
Excerpt only. Read the full label for complete information.
About NDC 0054-0010
- What is NDC 0054-0010?
- 0054-0010 is the product NDC for Flecainide Acetate, Flecainide acetate 50 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 3 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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 076278
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 | Hikma Pharmaceuticals USA Inc. | 0054-0011 |
| Flecainide Acetate | Flecainide acetate 150 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0012 |