propafenone hydrochloride

Generic: propafenone hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name propafenone hydrochloride
Generic Name propafenone hydrochloride
Labeler northstar rx llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

propafenone hydrochloride 425 mg/1

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 16714-827
Product ID 16714-827_59aaf0aa-9074-4563-93ba-1c97e76352a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205268
Listing Expiration 2026-12-31
Marketing Start 2017-03-31

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714827
Hyphenated Format 16714-827

Supplemental Identifiers

RxCUI
861156 861164 861171
UPC
0316714826011 0316714827018 0316714825014
UNII
33XCH0HOCD

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name propafenone hydrochloride (source: ndc)
Generic Name propafenone hydrochloride (source: ndc)
Application Number ANDA205268 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 425 mg/1
source: ndc
Packaging
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-827-01)
source: ndc

Packages (1)

16714-827-01 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-827-01)

Ingredients (1)

propafenone hydrochloride (425 mg/1)

Linked Drug Pages (1)

propafenone hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "59aaf0aa-9074-4563-93ba-1c97e76352a2", "openfda": {"upc": ["0316714826011", "0316714827018", "0316714825014"], "unii": ["33XCH0HOCD"], "rxcui": ["861156", "861164", "861171"], "spl_set_id": ["2ecd6452-ccc3-493f-9a4a-69f0fbf67a42"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-827-01)", "package_ndc": "16714-827-01", "marketing_start_date": "20180716"}], "brand_name": "propafenone hydrochloride", "product_id": "16714-827_59aaf0aa-9074-4563-93ba-1c97e76352a2", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "16714-827", "generic_name": "propafenone hydrochloride", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "propafenone hydrochloride", "active_ingredients": [{"name": "PROPAFENONE HYDROCHLORIDE", "strength": "425 mg/1"}], "application_number": "ANDA205268", "marketing_category": "ANDA", "marketing_start_date": "20170331", "listing_expiration_date": "20261231"}