Package 55513-710-01

Brand: prolia

Generic: denosumab
NDC Package

Package Facts

Identity

Package NDC 55513-710-01
Digits Only 5551371001
Product NDC 55513-710
Description

1 SYRINGE in 1 CARTON (55513-710-01) / 1 mL in 1 SYRINGE

Marketing

Marketing Status
Marketed Since 2010-06-05
Brand prolia
Generic denosumab
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["SUBCUTANEOUS"], "spl_id": "f5a330b4-e272-4aa1-9fce-afdfce5543aa", "openfda": {"nui": ["N0000187055", "N0000187054"], "unii": ["4EQZ6YO2HI"], "rxcui": ["993452", "993456"], "spl_set_id": ["49e5afe9-a0c7-40c4-af9f-f287a80c5c88"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["Amgen, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (55513-710-01)  / 1 mL in 1 SYRINGE", "package_ndc": "55513-710-01", "marketing_start_date": "20100605"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (55513-710-21)  / 1 mL in 1 SYRINGE", "package_ndc": "55513-710-21", "marketing_start_date": "20240305"}], "brand_name": "Prolia", "product_id": "55513-710_f5a330b4-e272-4aa1-9fce-afdfce5543aa", "dosage_form": "INJECTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "55513-710", "generic_name": "denosumab", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prolia", "active_ingredients": [{"name": "DENOSUMAB", "strength": "60 mg/mL"}], "application_number": "BLA125320", "marketing_category": "BLA", "marketing_start_date": "20100605", "listing_expiration_date": "20261231"}