Prescription drug · ANDA
Propafenone Hydrochloride NDC 68382-523
Propafenone hydrochloride 325 mg/1 · Capsule, Extended release · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-523-05 | 68382052305 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-523-05)Marketed from Feb 2, 2022 | |
| 68382-523-14 | 68382052314 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-523-14)Marketed from Feb 2, 2022 |
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)
- Propafenone Hydrochloride
- Generic name (nonproprietary)
- propafenone hydrochloride
- Active ingredients
- Propafenone hydrochloride — 325 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214184
- Marketing start
- Listing expires
- Identifiers
- Product ID 68382-523_a56d3284-65f2-4d77-bd0b-98afb084d7aaSPL ID a56d3284-65f2-4d77-bd0b-98afb084d7aaSPL set ID 163564b6-a8bf-4258-8ef9-19e33fb2d7bcRxCUI 861156, 861164, 861171UNII 33XCH0HOCDUPC 0368382524140, 0368382523143, 0368382522146
- 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
N468382052305followed by a unit qualifier and the quantityPackage 68382-0523-05. 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 extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF. Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214184
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 225 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-522 |
| Propafenone Hydrochloride | Propafenone hydrochloride 425 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-524 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1525 |
| Propafenone Hydrochloride | Propafenone hydrochloride 325 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1526 |
| Propafenone Hydrochloride | Propafenone hydrochloride 425 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1527 |