propafenone hydrochloride

Generic: propafenone hydrochloride

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name propafenone hydrochloride
Generic Name propafenone hydrochloride
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

propafenone hydrochloride 225 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-522
Product ID 68382-522_a56d3284-65f2-4d77-bd0b-98afb084d7aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214184
Listing Expiration 2026-12-31
Marketing Start 2022-02-02

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382522
Hyphenated Format 68382-522

Supplemental Identifiers

RxCUI
861156 861164 861171
UPC
0368382524140 0368382523143 0368382522146
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 ANDA214184 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 225 mg/1
source: ndc
Packaging
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-522-05)
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-522-14)
source: ndc

Packages (2)

68382-522-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-522-05) 68382-522-14 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-522-14)

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": "a56d3284-65f2-4d77-bd0b-98afb084d7aa", "openfda": {"upc": ["0368382524140", "0368382523143", "0368382522146"], "unii": ["33XCH0HOCD"], "rxcui": ["861156", "861164", "861171"], "spl_set_id": ["163564b6-a8bf-4258-8ef9-19e33fb2d7bc"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-522-05)", "package_ndc": "68382-522-05", "marketing_start_date": "20220202"}, {"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-522-14)", "package_ndc": "68382-522-14", "marketing_start_date": "20220202"}], "brand_name": "Propafenone Hydrochloride", "product_id": "68382-522_a56d3284-65f2-4d77-bd0b-98afb084d7aa", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "68382-522", "generic_name": "Propafenone Hydrochloride", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Propafenone Hydrochloride", "active_ingredients": [{"name": "PROPAFENONE HYDROCHLORIDE", "strength": "225 mg/1"}], "application_number": "ANDA214184", "marketing_category": "ANDA", "marketing_start_date": "20220202", "listing_expiration_date": "20261231"}