propafenone hydrochloride

Generic: propafenone hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name propafenone hydrochloride
Generic Name propafenone hydrochloride
Labeler aurobindo pharma limited
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

propafenone hydrochloride 425 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-278
Product ID 59651-278_ef0c975d-08ee-4649-9017-4f7f1a2981a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213096
Listing Expiration 2026-12-31
Marketing Start 2023-02-21

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651278
Hyphenated Format 59651-278

Supplemental Identifiers

RxCUI
861156 861164 861171
UPC
0359651278604
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 ANDA213096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 425 mg/1
source: ndc
Packaging
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-05)
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-60)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-90)
source: ndc

Packages (3)

59651-278-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-05) 59651-278-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-60) 59651-278-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-90)

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": "ef0c975d-08ee-4649-9017-4f7f1a2981a1", "openfda": {"upc": ["0359651278604"], "unii": ["33XCH0HOCD"], "rxcui": ["861156", "861164", "861171"], "spl_set_id": ["1c4fc726-3f5b-4b12-a66e-727c5133d1d9"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-05)", "package_ndc": "59651-278-05", "marketing_start_date": "20230221"}, {"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-60)", "package_ndc": "59651-278-60", "marketing_start_date": "20230221"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-90)", "package_ndc": "59651-278-90", "marketing_start_date": "20230221"}], "brand_name": "Propafenone Hydrochloride", "product_id": "59651-278_ef0c975d-08ee-4649-9017-4f7f1a2981a1", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "59651-278", "generic_name": "Propafenone Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Propafenone Hydrochloride", "active_ingredients": [{"name": "PROPAFENONE HYDROCHLORIDE", "strength": "425 mg/1"}], "application_number": "ANDA213096", "marketing_category": "ANDA", "marketing_start_date": "20230221", "listing_expiration_date": "20261231"}