Package 68382-298-06
Brand: amiodarone hydrochloride
Generic: amiodarone hydrochloridePackage Facts
Identity
Package NDC
68382-298-06
Digits Only
6838229806
Product NDC
68382-298
Description
30 TABLET in 1 BOTTLE (68382-298-06)
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": ["ORAL"], "spl_id": "b3f11ad6-9f3b-4054-9c51-3d2614c1002e", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["833528", "834348", "835956"], "spl_set_id": ["b41cbcb5-9c5d-4e45-a4f2-952df5f22c00"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-298-06)", "package_ndc": "68382-298-06", "marketing_start_date": "20230209"}], "brand_name": "amiodarone hydrochloride", "product_id": "68382-298_b3f11ad6-9f3b-4054-9c51-3d2614c1002e", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "68382-298", "generic_name": "amiodarone hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "amiodarone hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "ANDA079029", "marketing_category": "ANDA", "marketing_start_date": "20230209", "listing_expiration_date": "20261231"}