propafenone hydrochloride

Generic: propafenone hydrochloride

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

propafenone hydrochloride 425 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-410
Product ID 68462-410_9b3e09a2-c396-425e-a1dc-e37cd44b612d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205268
Listing Expiration 2027-12-31
Marketing Start 2017-09-08

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462410
Hyphenated Format 68462-410

Supplemental Identifiers

RxCUI
861156 861164 861171
UPC
0368462409602 0368462410608 0368462408605
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 ANDA205268 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 425 mg/1
source: ndc
Packaging
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-410-60)
source: ndc

Packages (1)

68462-410-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-410-60)

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": "9b3e09a2-c396-425e-a1dc-e37cd44b612d", "openfda": {"upc": ["0368462409602", "0368462410608", "0368462408605"], "unii": ["33XCH0HOCD"], "rxcui": ["861156", "861164", "861171"], "spl_set_id": ["d818af31-2535-4595-82fe-fd7abf66fd6c"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-410-60)", "package_ndc": "68462-410-60", "marketing_start_date": "20170908"}], "brand_name": "propafenone hydrochloride", "product_id": "68462-410_9b3e09a2-c396-425e-a1dc-e37cd44b612d", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "68462-410", "generic_name": "propafenone hydrochloride", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "propafenone hydrochloride", "active_ingredients": [{"name": "PROPAFENONE HYDROCHLORIDE", "strength": "425 mg/1"}], "application_number": "ANDA205268", "marketing_category": "ANDA", "marketing_start_date": "20170908", "listing_expiration_date": "20271231"}