detectnet

Generic: copper cu 64 dotatate

Labeler: curium us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name detectnet
Generic Name copper cu 64 dotatate
Labeler curium us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

copper oxodotreotide cu-64 1 mCi/mL

Manufacturer
CURIUM US LLC

Identifiers & Regulatory

Product NDC 69945-064
Product ID 69945-064_2d08d179-39bb-5cd0-e063-6394a90a8ab0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213227
Listing Expiration 2026-12-31
Marketing Start 2020-09-14

Pharmacologic Class

Established (EPC)
radioactive diagnostic agent [epc]
Mechanism of Action
positron emitting activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69945064
Hyphenated Format 69945-064

Supplemental Identifiers

UNII
N3858377KC
NUI
N0000177914 N0000175869

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 detectnet (source: ndc)
Generic Name copper cu 64 dotatate (source: ndc)
Application Number NDA213227 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mCi/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CAN (69945-064-01) / 4 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

69945-064-01 1 VIAL, SINGLE-USE in 1 CAN (69945-064-01) / 4 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

copper oxodotreotide cu-64 (1 mCi/mL)

Linked Drug Pages (1)

Detectnet ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2d08d179-39bb-5cd0-e063-6394a90a8ab0", "openfda": {"nui": ["N0000177914", "N0000175869"], "unii": ["N3858377KC"], "spl_set_id": ["f898c8a7-beb7-4318-a8ea-6f058d69342b"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Positron Emitting Activity [MoA]"], "manufacturer_name": ["CURIUM US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CAN (69945-064-01)  / 4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "69945-064-01", "marketing_start_date": "20200914"}], "brand_name": "Detectnet", "product_id": "69945-064_2d08d179-39bb-5cd0-e063-6394a90a8ab0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Positron Emitting Activity [MoA]", "Radioactive Diagnostic Agent [EPC]"], "product_ndc": "69945-064", "generic_name": "copper Cu 64 Dotatate", "labeler_name": "CURIUM US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Detectnet", "active_ingredients": [{"name": "COPPER OXODOTREOTIDE CU-64", "strength": "1 mCi/mL"}], "application_number": "NDA213227", "marketing_category": "NDA", "marketing_start_date": "20200914", "listing_expiration_date": "20261231"}