Package 65219-643-03

Brand: amiodarone hydrochloride

Generic: amiodarone hydrochloride
NDC Package

Package Facts

Identity

Package NDC 65219-643-03
Digits Only 6521964303
Product NDC 65219-643
Product ID 65219-643_9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a
Description

25 VIAL, SINGLE-DOSE in 1 TRAY (65219-643-03) / 3 mL in 1 VIAL, SINGLE-DOSE (65219-643-01)

Marketing

Marketing Status
Marketed Since 2025-05-05
Brand amiodarone hydrochloride
Generic amiodarone hydrochloride
Sample Package No

Linked Drug Pages (1)

Amiodarone Hydrochloride ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a", "openfda": {"upc": ["0365219645016"], "unii": ["976728SY6Z"], "rxcui": ["1663224", "1663244"], "spl_set_id": ["9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (65219-643-03)  / 3 mL in 1 VIAL, SINGLE-DOSE (65219-643-01)", "package_ndc": "65219-643-03", "marketing_start_date": "20250505"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "65219-643_9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antiarrhythmic [EPC]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "65219-643", "generic_name": "AMIODARONE HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA075761", "marketing_category": "ANDA", "marketing_start_date": "20250505", "listing_expiration_date": "20261231"}