Package 0078-1007-68

Brand: kesimpta

Generic: ofatumumab
NDC Package

Package Facts

Identity

Package NDC 0078-1007-68
Digits Only 0078100768
Product NDC 0078-1007
Description

1 SYRINGE, GLASS in 1 CARTON (0078-1007-68) / .4 mL in 1 SYRINGE, GLASS

Marketing

Marketing Status
Marketed Since 2020-08-20
Brand kesimpta
Generic ofatumumab
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["SUBCUTANEOUS"], "spl_id": "2a949531-807f-4e6e-9ac0-68943e6c6685", "openfda": {"nui": ["N0000175657", "N0000175078"], "unii": ["M95KG522R0"], "rxcui": ["2390949", "2390954"], "spl_set_id": ["6a8a3f53-2062-48ff-9dbe-b939df133ca3"], "pharm_class_epc": ["CD20-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD20-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (0078-1007-68)  / .4 mL in 1 SYRINGE, GLASS", "package_ndc": "0078-1007-68", "marketing_start_date": "20200820"}, {"sample": true, "description": "1 SYRINGE, GLASS in 1 CARTON (0078-1007-98)  / .4 mL in 1 SYRINGE, GLASS", "package_ndc": "0078-1007-98", "marketing_start_date": "20200820"}], "brand_name": "KESIMPTA", "product_id": "0078-1007_2a949531-807f-4e6e-9ac0-68943e6c6685", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]"], "product_ndc": "0078-1007", "generic_name": "ofatumumab", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KESIMPTA", "active_ingredients": [{"name": "OFATUMUMAB", "strength": "20 mg/.4mL"}], "application_number": "BLA125326", "marketing_category": "BLA", "marketing_start_date": "20091026", "listing_expiration_date": "20261231"}