Package 72078-046-18
Brand: amiodarone hydrochloride
Generic: amiodarone hydrochloridePackage Facts
Identity
Package NDC
72078-046-18
Digits Only
7207804618
Product NDC
72078-046
Description
1 VIAL, GLASS in 1 CARTON (72078-046-18) / 18 mL in 1 VIAL, GLASS
Marketing
Marketing Status
Brand
amiodarone hydrochloride
Generic
amiodarone hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "7cfc7c84-7d98-4060-bb6c-8268244be3cb", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["1663244", "1663248"], "spl_set_id": ["f0b3b743-9f62-4b02-ace5-c8d93637ecad"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (72078-046-09) / 9 mL in 1 VIAL, GLASS (72078-046-00)", "package_ndc": "72078-046-09", "marketing_start_date": "20230609"}, {"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (72078-046-18) / 18 mL in 1 VIAL, GLASS", "package_ndc": "72078-046-18", "marketing_start_date": "20230609"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "72078-046_7cfc7c84-7d98-4060-bb6c-8268244be3cb", "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": "72078-046", "generic_name": "amiodarone hydrochloride", "labeler_name": "Mylan Institutional LLC", "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": "20230609", "listing_expiration_date": "20261231"}