Package 83457-012-10

Brand: ospomyv

Generic: denosumab
NDC Package

Package Facts

Identity

Package NDC 83457-012-10
Digits Only 8345701210
Product NDC 83457-012
Product ID 83457-012_701ab9b4-0ad7-4b34-b66f-f75b41d0e1e9
Description

1 SYRINGE in 1 CARTON (83457-012-10) / 1 mL in 1 SYRINGE

Marketing

Marketing Status
Marketed Since 2025-10-10
Brand ospomyv
Generic denosumab
Sample Package No

Linked Drug Pages (1)

OSPOMYV ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "701ab9b4-0ad7-4b34-b66f-f75b41d0e1e9", "openfda": {"nui": ["N0000187055", "N0000187054"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2725502", "2725509"], "spl_set_id": ["e1d80a82-de52-4a34-9df3-609e50667ffb"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["Cordavis Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (83457-012-10)  / 1 mL in 1 SYRINGE", "package_ndc": "83457-012-10", "marketing_start_date": "20251010"}], "brand_name": "OSPOMYV", "product_id": "83457-012_701ab9b4-0ad7-4b34-b66f-f75b41d0e1e9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "83457-012", "generic_name": "denosumab", "labeler_name": "Cordavis Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OSPOMYV", "active_ingredients": [{"name": "DENOSUMAB", "strength": "60 mg/mL"}], "application_number": "BLA761392", "marketing_category": "BLA", "marketing_start_date": "20251010", "listing_expiration_date": "20261231"}