Package 84549-153-03

Brand: amiodarone hydrochloride

Generic: amiodarone hydrochloride
NDC Package

Package Facts

Identity

Package NDC 84549-153-03
Digits Only 8454915303
Product NDC 84549-153
Product ID 84549-153_462a9d14-baa5-8d4b-e063-6394a90a0d58
Description

3 mL in 1 VIAL, GLASS (84549-153-03)

Marketing

Marketing Status
Marketed Since 2025-08-27
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": "462a9d14-baa5-8d4b-e063-6394a90a0d58", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["1663224"], "spl_set_id": ["364ab45e-b525-f310-e063-6394a90a4421"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "3 mL in 1 VIAL, GLASS (84549-153-03)", "package_ndc": "84549-153-03", "marketing_start_date": "20250827"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "84549-153_462a9d14-baa5-8d4b-e063-6394a90a0d58", "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": "84549-153", "generic_name": "amiodarone hydrochloride", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA076217", "marketing_category": "ANDA", "marketing_start_date": "20021014", "listing_expiration_date": "20261231"}