propafenone hydrochloride

Generic: propafenone hydrochloride

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

Drug Facts

Product Profile

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

propafenone hydrochloride 325 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-185
Product ID 64380-185_115db966-fda6-47dc-a699-e8a1180385d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078540
Listing Expiration 2026-12-31
Marketing Start 2022-04-04

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380185
Hyphenated Format 64380-185

Supplemental Identifiers

RxCUI
861156 861164 861171
UPC
0364380186014 0364380186021 0364380184010 0364380185017 0364380185024 0364380184027
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 ANDA078540 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
source: ndc
Packaging
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-01)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-02)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-04)
source: ndc

Packages (3)

64380-185-01 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-01) 64380-185-02 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-02) 64380-185-04 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-04)

Ingredients (1)

propafenone hydrochloride (325 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": "115db966-fda6-47dc-a699-e8a1180385d8", "openfda": {"upc": ["0364380186014", "0364380186021", "0364380184010", "0364380185017", "0364380185024", "0364380184027"], "unii": ["33XCH0HOCD"], "rxcui": ["861156", "861164", "861171"], "spl_set_id": ["3fc0800c-c063-48f8-ab4e-9aa9a4c3841f"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-01)", "package_ndc": "64380-185-01", "marketing_start_date": "20220404"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-02)", "package_ndc": "64380-185-02", "marketing_start_date": "20220404"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-185-04)", "package_ndc": "64380-185-04", "marketing_start_date": "20220930"}], "brand_name": "Propafenone Hydrochloride", "product_id": "64380-185_115db966-fda6-47dc-a699-e8a1180385d8", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "64380-185", "generic_name": "propafenone hydrochloride", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Propafenone Hydrochloride", "active_ingredients": [{"name": "PROPAFENONE HYDROCHLORIDE", "strength": "325 mg/1"}], "application_number": "ANDA078540", "marketing_category": "ANDA", "marketing_start_date": "20220404", "listing_expiration_date": "20261231"}