Prescription drug · ANDA
Propafenone Hydrochloride NDC 63629-1988
Propafenone hydrochloride 225 mg/1 · Tablet, Coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1988-1 | 63629198801 | 100 TABLET, COATED in 1 BOTTLE (63629-1988-1)Marketed from Feb 2, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Propafenone Hydrochloride
- Generic name (nonproprietary)
- propafenone hydrochloride
- Active ingredients
- Propafenone hydrochloride — 225 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076550
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-1988_ff1cd958-1b7d-422c-bdfd-0fad7d98d6bcSPL ID ff1cd958-1b7d-422c-bdfd-0fad7d98d6bcSPL set ID 2492317c-8b04-477e-a5d2-53e791fface9RxCUI 861427UNII 33XCH0HOCD
- 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
N463629198801followed by a unit qualifier and the quantityPackage 63629-1988-01. 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)
Propafenone Hydrochloride Tablets are indicated to: • prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease. • prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease. • treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital. Usage Considerations: • The use of Propafenone Hydrochloride Tablets in patients with permanent atrial fibrillation (AF) or in patients ex…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076550
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 |
|---|---|---|---|---|
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, CoatedOral | ANI Pharmaceuticals, Inc. | 62559-230 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, CoatedOral | ANI Pharmaceuticals, Inc. | 62559-231 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, CoatedOral | ANI Pharmaceuticals, Inc. | 62559-232 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 72162-1752 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 72162-1753 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 63629-9280 |
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-2780 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 63629-1989 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-4227 |
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 63629-2105 |
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 72162-1751 |
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, CoatedOral | Golden State Medical Supply, Inc. | 51407-015 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, CoatedOral | Golden State Medical Supply, Inc. | 51407-016 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, CoatedOral | Golden State Medical Supply, Inc. | 51407-017 |