lutathera

Generic: lutetium lu 177 dotatate

Labeler: advanced accelerator applications usa, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lutathera
Generic Name lutetium lu 177 dotatate
Labeler advanced accelerator applications usa, inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

lutetium oxodotreotide lu-177 10 mCi/mL

Manufacturer
Advanced Accelerator Applications USA, Inc

Identifiers & Regulatory

Product NDC 69488-003
Product ID 69488-003_74d44dec-f079-43b7-94ac-989a948f53ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208700
Listing Expiration 2027-12-31
Marketing Start 2018-01-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69488003
Hyphenated Format 69488-003

Supplemental Identifiers

RxCUI
1999682 1999687
UNII
AE221IM3BB

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lutathera (source: ndc)
Generic Name lutetium lu 177 dotatate (source: ndc)
Application Number NDA208700 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mCi/mL
source: ndc
Packaging
  • 1 VIAL in 1 PACKAGE (69488-003-01) / 20.5 mL in 1 VIAL
source: ndc

Packages (1)

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

Ingredients (1)

lutetium oxodotreotide lu-177 (10 mCi/mL)

Linked Drug Pages (1)

Lutathera ndc-match (0.9)

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"}