Package 0078-0669-13
Brand: ARZERRA
Generic: ofatumumabPackage Facts
Identity
Package NDC
0078-0669-13
Digits Only
0078066913
Product NDC
0078-0669
Description
3 VIAL, SINGLE-USE in 1 CARTON (0078-0669-13) / 5 mL in 1 VIAL, SINGLE-USE (0078-0669-61)
Marketing
Marketing Status
Brand
ARZERRA
Generic
ofatumumab
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "eaccfff4-b2fd-49e0-88f8-ca3ce2738be7", "openfda": {"nui": ["N0000175657", "N0000175078"], "unii": ["M95KG522R0"], "rxcui": ["1658042", "1658044", "1658047", "1658048"], "spl_set_id": ["77785ce3-e8df-4ca1-8f8e-6c418c6a17de"], "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": "3 VIAL, SINGLE-USE in 1 CARTON (0078-0669-13) / 5 mL in 1 VIAL, SINGLE-USE (0078-0669-61)", "package_ndc": "0078-0669-13", "marketing_start_date": "20160201"}], "brand_name": "ARZERRA", "product_id": "0078-0669_eaccfff4-b2fd-49e0-88f8-ca3ce2738be7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]"], "product_ndc": "0078-0669", "generic_name": "ofatumumab", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ARZERRA", "active_ingredients": [{"name": "OFATUMUMAB", "strength": "20 mg/mL"}], "application_number": "BLA125326", "marketing_category": "BLA", "marketing_start_date": "20160201", "listing_expiration_date": "20261231"}