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 TABLET, FILM COATED
Routes
ORAL
Active Ingredients

propafenone hydrochloride 225 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-268
Product ID 64380-268_e3779c96-a513-4375-857e-bbe3b2532d64
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075938
Listing Expiration 2026-12-31
Marketing Start 2025-05-05

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380268
Hyphenated Format 64380-268

Supplemental Identifiers

RxCUI
861424 861427 861430
UPC
0364380246015 0364380268024 0364380269021
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 ANDA075938 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 225 mg/1
source: ndc
Packaging
  • 300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-268-01)
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-268-02)
source: ndc

Packages (2)

64380-268-01 300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-268-01) 64380-268-02 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-268-02)

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": "e3779c96-a513-4375-857e-bbe3b2532d64", "openfda": {"upc": ["0364380246015", "0364380268024", "0364380269021"], "unii": ["33XCH0HOCD"], "rxcui": ["861424", "861427", "861430"], "spl_set_id": ["c65253ab-937f-4982-b841-69c2b9f9ccdb"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-268-01)", "package_ndc": "64380-268-01", "marketing_start_date": "20250505"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-268-02)", "package_ndc": "64380-268-02", "marketing_start_date": "20250505"}], "brand_name": "PROPAFENONE HYDROCHLORIDE", "product_id": "64380-268_e3779c96-a513-4375-857e-bbe3b2532d64", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "64380-268", "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": "225 mg/1"}], "application_number": "ANDA075938", "marketing_category": "ANDA", "marketing_start_date": "20250505", "listing_expiration_date": "20261231"}