Package 68083-382-01

Brand: irinotecan hydrochloride

Generic: irinotecan hydrochloride
NDC Package

Package Facts

Identity

Package NDC 68083-382-01
Digits Only 6808338201
Product NDC 68083-382
Product ID 68083-382_a1ced9af-9117-485c-925d-47f7266bc9df
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (68083-382-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2019-11-18
Brand irinotecan hydrochloride
Generic irinotecan hydrochloride
Sample Package No

Linked Drug Pages (1)

Irinotecan hydrochloide, Irinotecan hydrochloride ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a1ced9af-9117-485c-925d-47f7266bc9df", "openfda": {"upc": ["0336808338107", "0368083382018"], "unii": ["042LAQ1IIS"], "rxcui": ["1726319", "1726324"], "spl_set_id": ["de634e80-328a-4473-b395-0172683a2411"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-382-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-382-01", "marketing_start_date": "20191118"}], "brand_name": "Irinotecan hydrochloride", "product_id": "68083-382_a1ced9af-9117-485c-925d-47f7266bc9df", "dosage_form": "INJECTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "68083-382", "generic_name": "Irinotecan hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irinotecan hydrochloride", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA212993", "marketing_category": "ANDA", "marketing_start_date": "20191118", "listing_expiration_date": "20261231"}