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NDC 16714-0827-01 propafenone hydrochloride 425 mg/1 Details
propafenone hydrochloride 425 mg/1
propafenone hydrochloride is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Northstar Rx LLC. The primary component is PROPAFENONE HYDROCHLORIDE.
MedlinePlus Drug Summary
Propafenone is used to treat arrhythmia (irregular heartbeat) and to maintain a normal heart rate. Propafenone is in a class of medications called antiarrhythmics. It works by acting on the heart muscle to improve the heart's rhythm.
Related Packages: 16714-0827-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Propafenone
Product Information
| NDC | 16714-0827 |
|---|---|
| Product ID | 16714-827_59aaf0aa-9074-4563-93ba-1c97e76352a2 |
| Associated GPIs | 35300050006940 |
| GCN Sequence Number | 053541 |
| GCN Sequence Number Description | propafenone HCl CAP ER 12H 425 MG ORAL |
| HIC3 | A2A |
| HIC3 Description | ANTIARRHYTHMICS |
| GCN | 21059 |
| HICL Sequence Number | 004833 |
| HICL Sequence Number Description | PROPAFENONE HCL |
| Brand/Generic | Generic |
| Proprietary Name | propafenone hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | propafenone hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 425 |
| Active Ingredient Units | mg/1 |
| Substance Name | PROPAFENONE HYDROCHLORIDE |
| Labeler Name | Northstar Rx LLC |
| Pharmaceutical Class | Antiarrhythmic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205268 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 16714-0827-01 (16714082701)
| NDC Package Code | 16714-827-01 |
|---|---|
| Billing NDC | 16714082701 |
| Package | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-827-01) |
| Marketing Start Date | 2018-07-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |