propafenone hydrochloride

Generic: propafenone

Labeler: vitruvias therapeutics
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name propafenone hydrochloride
Generic Name propafenone
Labeler vitruvias therapeutics
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

propafenone hydrochloride 225 mg/1

Manufacturer
Vitruvias Therapeutics

Identifiers & Regulatory

Product NDC 69680-130
Product ID 69680-130_827a5fb5-9318-4116-9e23-6b75e469dd77
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210339
Listing Expiration 2026-12-31
Marketing Start 2019-01-28

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69680130
Hyphenated Format 69680-130

Supplemental Identifiers

RxCUI
861156 861164 861171
UPC
0369680132600 0369680130606 0369680130927 0369680132921 0369680131924 0369680131603
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 (source: ndc)
Application Number ANDA210339 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 225 mg/1
source: ndc
Packaging
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-60)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-92)
source: ndc

Packages (2)

69680-130-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-60) 69680-130-92 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-92)

Ingredients (1)

propafenone hydrochloride (225 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": "827a5fb5-9318-4116-9e23-6b75e469dd77", "openfda": {"upc": ["0369680132600", "0369680130606", "0369680130927", "0369680132921", "0369680131924", "0369680131603"], "unii": ["33XCH0HOCD"], "rxcui": ["861156", "861164", "861171"], "spl_set_id": ["bc1d2548-15a3-4986-92b1-c3ddfb35343a"], "manufacturer_name": ["Vitruvias Therapeutics"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-60)", "package_ndc": "69680-130-60", "marketing_start_date": "20190128"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-92)", "package_ndc": "69680-130-92", "marketing_start_date": "20190128"}], "brand_name": "Propafenone Hydrochloride", "product_id": "69680-130_827a5fb5-9318-4116-9e23-6b75e469dd77", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "69680-130", "generic_name": "propafenone", "labeler_name": "Vitruvias Therapeutics", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Propafenone Hydrochloride", "active_ingredients": [{"name": "PROPAFENONE HYDROCHLORIDE", "strength": "225 mg/1"}], "application_number": "ANDA210339", "marketing_category": "ANDA", "marketing_start_date": "20190128", "listing_expiration_date": "20261231"}