Prescription drug · ANDA
propafenone hydrochloride NDC 16714-825
Propafenone hydrochloride 225 mg/1 · Capsule, Extended release · Oral · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-825-01 | 16714082501 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-825-01)Marketed from Jul 16, 2018 |
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 — 225 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Northstar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205268
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-825_2f88518a-063e-435c-82bf-1b23f35e5451SPL ID 2f88518a-063e-435c-82bf-1b23f35e5451SPL set ID 2ecd6452-ccc3-493f-9a4a-69f0fbf67a42RxCUI 861156, 861164, 861171UNII 33XCH0HOCDUPC 0316714826011, 0316714827018
- 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
N416714082501followed by a unit qualifier and the quantityPackage 16714-0825-01. 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 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 incre…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205268
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 425 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-410 |
| propafenone hydrochloride | Propafenone hydrochloride 225 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-408 |
| propafenone hydrochloride | Propafenone hydrochloride 325 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-409 |
| propafenone hydrochloride | Propafenone hydrochloride 325 mg/1 | Capsule, Extended releaseOral | Northstar Rx LLC | 16714-826 |
| propafenone hydrochloride | Propafenone hydrochloride 425 mg/1 | Capsule, Extended releaseOral | Northstar Rx LLC | 16714-827 |