Prescription drug · ANDA
Propafenone Hydrochloride NDC 0832-0740
Propafenone hydrochloride 225 mg/1 · Capsule, Extended release · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-0740-60 | 00832074060 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0740-60)Marketed from Jun 25, 2020 |
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)
- Propafenone Hydrochloride
- Generic name (nonproprietary)
- propafenone hydrochloride
- Active ingredients
- Propafenone hydrochloride — 225 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212744
- Marketing start
- Marketing end
- Identifiers
- Product ID 0832-0740_45afbac0-5c1a-ebc5-e063-6294a90a4d5eSPL ID 45afbac0-5c1a-ebc5-e063-6294a90a4d5eSPL set ID 8aa6f58a-2980-4caa-9c54-d55d69d5d132RxCUI 861156, 861164, 861171UNII 33XCH0HOCDUPC 0308320740607
- 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
N400832074060followed by a unit qualifier and the quantityPackage 00832-0740-60. 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. Propafenone hydrochloride extended-release capsules are an antiarrhythmic 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. ( 1 ) Usage Considerations: Use in patients with permanent atrial fibrillation or with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212744
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 325 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-0741 |
| Propafenone Hydrochloride | Propafenone hydrochloride 425 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-0742 |