Package 75987-130-15
Brand: tepezza
Generic: teprotumumabPackage Facts
Identity
Package NDC
75987-130-15
Digits Only
7598713015
Product NDC
75987-130
Description
1 VIAL, SINGLE-DOSE in 1 CARTON (75987-130-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Marketing
Marketing Status
Brand
tepezza
Generic
teprotumumab
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "ade7436a-343e-43c8-964d-5aca91c4feaa", "openfda": {"nui": ["N0000193926", "N0000193927"], "unii": ["Y64GQ0KC0A"], "rxcui": ["2274807", "2274812"], "spl_set_id": ["3e6c54a1-cefd-4a5b-a855-ab9f268b6cce"], "pharm_class_epc": ["Insulin-like Growth Factor-1 Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Insulin-like Growth Factor-1 Receptor Inhibitors [MoA]"], "manufacturer_name": ["Horizon Therapeutics USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (75987-130-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "75987-130-15", "marketing_start_date": "20200121"}], "brand_name": "TEPEZZA", "product_id": "75987-130_ade7436a-343e-43c8-964d-5aca91c4feaa", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Insulin-like Growth Factor-1 Receptor Inhibitor [EPC]", "Insulin-like Growth Factor-1 Receptor Inhibitors [MoA]"], "product_ndc": "75987-130", "generic_name": "teprotumumab", "labeler_name": "Horizon Therapeutics USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEPEZZA", "active_ingredients": [{"name": "TEPROTUMUMAB", "strength": "500 mg/1"}], "application_number": "BLA761143", "marketing_category": "BLA", "marketing_start_date": "20200121", "listing_expiration_date": "20261231"}