propafenone hydrochloride

Generic: propafenone hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name propafenone hydrochloride
Generic Name propafenone hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

propafenone hydrochloride 225 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-736
Product ID 16571-736_36cf4555-6fe9-42d8-8d3b-3ca9c134a5b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205956
Listing Expiration 2026-12-31
Marketing Start 2020-12-16

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571736
Hyphenated Format 16571-736

Supplemental Identifiers

RxCUI
861156 861164 861171
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 ANDA205956 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 225 mg/1
source: ndc
Packaging
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16571-736-06)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16571-736-50)
source: ndc

Packages (2)

Ingredients (1)

propafenone hydrochloride (225 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "36cf4555-6fe9-42d8-8d3b-3ca9c134a5b8", "openfda": {"unii": ["33XCH0HOCD"], "rxcui": ["861156", "861164", "861171"], "spl_set_id": ["36cf4555-6fe9-42d8-8d3b-3ca9c134a5b8"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16571-736-06)", "package_ndc": "16571-736-06", "marketing_start_date": "20201216"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16571-736-50)", "package_ndc": "16571-736-50", "marketing_start_date": "20201216"}], "brand_name": "PROPAFENONE HYDROCHLORIDE", "product_id": "16571-736_36cf4555-6fe9-42d8-8d3b-3ca9c134a5b8", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "16571-736", "generic_name": "PROPAFENONE HYDROCHLORIDE", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROPAFENONE HYDROCHLORIDE", "active_ingredients": [{"name": "PROPAFENONE HYDROCHLORIDE", "strength": "225 mg/1"}], "application_number": "ANDA205956", "marketing_category": "ANDA", "marketing_start_date": "20201216", "listing_expiration_date": "20261231"}