Package 69488-003-01

Brand: lutathera

Generic: lutetium lu 177 dotatate
NDC Package

Package Facts

Identity

Package NDC 69488-003-01
Digits Only 6948800301
Product NDC 69488-003
Product ID 69488-003_74d44dec-f079-43b7-94ac-989a948f53ec
Description

1 VIAL in 1 PACKAGE (69488-003-01) / 20.5 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2018-01-26
Brand lutathera
Generic lutetium lu 177 dotatate
Sample Package No

Linked Drug Pages (1)

Lutathera ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "74d44dec-f079-43b7-94ac-989a948f53ec", "openfda": {"unii": ["AE221IM3BB"], "rxcui": ["1999682", "1999687"], "spl_set_id": ["72d1a024-00b7-418a-b36e-b2cb48f2ab55"], "manufacturer_name": ["Advanced Accelerator Applications USA, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 PACKAGE (69488-003-01)  / 20.5 mL in 1 VIAL", "package_ndc": "69488-003-01", "marketing_start_date": "20180126"}], "brand_name": "Lutathera", "product_id": "69488-003_74d44dec-f079-43b7-94ac-989a948f53ec", "dosage_form": "INJECTION", "product_ndc": "69488-003", "generic_name": "Lutetium Lu 177 dotatate", "labeler_name": "Advanced Accelerator Applications USA, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lutathera", "active_ingredients": [{"name": "LUTETIUM OXODOTREOTIDE LU-177", "strength": "10 mCi/mL"}], "application_number": "NDA208700", "marketing_category": "NDA", "marketing_start_date": "20180126", "listing_expiration_date": "20271231"}