propafenone hydrochloride

Generic: propafenone hydrochloride

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

propafenone hydrochloride 225 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1525
Product ID 70771-1525_e7389f3e-074b-44ca-b767-5520390265e5
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 707711525
Hyphenated Format 70771-1525

Supplemental Identifiers

RxCUI
861156 861164 861171
UPC
0370771152766
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 (70771-1525-5)
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1525-6)
source: ndc

Packages (2)

70771-1525-5 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1525-5) 70771-1525-6 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1525-6)

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": "e7389f3e-074b-44ca-b767-5520390265e5", "openfda": {"upc": ["0370771152766"], "unii": ["33XCH0HOCD"], "rxcui": ["861156", "861164", "861171"], "spl_set_id": ["b41ec863-5734-41a3-9837-6c0a962ec6eb"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1525-5)", "package_ndc": "70771-1525-5", "marketing_start_date": "20220202"}, {"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1525-6)", "package_ndc": "70771-1525-6", "marketing_start_date": "20220202"}], "brand_name": "Propafenone Hydrochloride", "product_id": "70771-1525_e7389f3e-074b-44ca-b767-5520390265e5", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "70771-1525", "generic_name": "Propafenone Hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "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"}