Package 83090-011-01

Brand: daptomycin

Generic: daptomycin
NDC Package

Package Facts

Identity

Package NDC 83090-011-01
Digits Only 8309001101
Product NDC 83090-011
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (83090-011-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2023-11-05
Brand daptomycin
Generic daptomycin
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "5ef48d1a-eecc-4782-b347-7930a733e603", "openfda": {"nui": ["N0000175509", "M0519359"], "upc": ["0383090011010"], "unii": ["NWQ5N31VKK"], "rxcui": ["403920"], "spl_set_id": ["0e55bfa7-7dbf-4fa1-8aee-eac3fe4e05e3"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Sintetica US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83090-011-01)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83090-011-01", "marketing_start_date": "20231105"}], "brand_name": "daptomycin", "product_id": "83090-011_5ef48d1a-eecc-4782-b347-7930a733e603", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "83090-011", "generic_name": "daptomycin", "labeler_name": "Sintetica US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "500 mg/20mL"}], "application_number": "ANDA215890", "marketing_category": "ANDA", "marketing_start_date": "20231105", "listing_expiration_date": "20261231"}