Package 0404-9815-03
Brand: amiodarone hydrochloride
Generic: amiodarone hydrochloridePackage Facts
Identity
Package NDC
0404-9815-03
Digits Only
0404981503
Product NDC
0404-9815
Description
1 VIAL, SINGLE-DOSE in 1 BAG (0404-9815-03) / 3 mL in 1 VIAL, SINGLE-DOSE
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": "7bee583d-d110-411d-b6e2-4e1157594be7", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["1663224"], "spl_set_id": ["545e9d26-0b4a-4784-b9c4-f8d62caf3a7c"], "manufacturer_name": ["Henry Schein, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9815-03) / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9815-03", "marketing_end_date": "20260331", "marketing_start_date": "20220108"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "0404-9815_7bee583d-d110-411d-b6e2-4e1157594be7", "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": "0404-9815", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Henry Schein, Inc", "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_end_date": "20260331", "marketing_start_date": "20220108"}