Package 68083-112-01

Brand: amiodarone hydrochloride

Generic: amiodarone hydrochloride
NDC Package

Package Facts

Identity

Package NDC 68083-112-01
Digits Only 6808311201
Product NDC 68083-112
Description

10 SYRINGE in 1 CARTON (68083-112-01) / 3 mL in 1 SYRINGE

Marketing

Marketing Status
Marketed Since 2013-07-15
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": "2c1bc6a8-20ff-483a-ae28-fb31fa5f684a", "openfda": {"upc": ["0368083112011"], "unii": ["976728SY6Z"], "rxcui": ["834357"], "spl_set_id": ["1f00c333-9667-4ebc-8849-009a3779c0c9"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (68083-112-01)  / 3 mL in 1 SYRINGE", "package_ndc": "68083-112-01", "marketing_start_date": "20130715"}], "brand_name": "Amiodarone hydrochloride", "product_id": "68083-112_2c1bc6a8-20ff-483a-ae28-fb31fa5f684a", "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 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "68083-112", "generic_name": "Amiodarone hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA077161", "marketing_category": "ANDA", "marketing_start_date": "20130715", "listing_expiration_date": "20261231"}