fludeoxyglucose f 18

Generic: fludeoxyglucose f 18

Labeler: the university of utah dba cyclotron radiochemistry lab / huntsman cancer institute
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludeoxyglucose f 18
Generic Name fludeoxyglucose f 18
Labeler the university of utah dba cyclotron radiochemistry lab / huntsman cancer institute
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fludeoxyglucose f-18 300 mCi/mL

Manufacturer
The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute

Identifiers & Regulatory

Product NDC 67939-010
Product ID 67939-010_d93db56f-430e-5490-e053-2995a90ace22
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204498
Listing Expiration 2026-12-31
Marketing Start 2013-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67939010
Hyphenated Format 67939-010

Supplemental Identifiers

UNII
0Z5B2CJX4D
NUI
N0000177914 N0000000205

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 fludeoxyglucose f 18 (source: ndc)
Generic Name fludeoxyglucose f 18 (source: ndc)
Application Number ANDA204498 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mCi/mL
source: ndc
Packaging
  • 50 mL in 1 VIAL, MULTI-DOSE (67939-010-50)
source: ndc

Packages (1)

67939-010-50 50 mL in 1 VIAL, MULTI-DOSE (67939-010-50)

Ingredients (1)

fludeoxyglucose f-18 (300 mCi/mL)

Linked Drug Pages (1)

Fludeoxyglucose F 18 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d93db56f-430e-5490-e053-2995a90ace22", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["0Z5B2CJX4D"], "spl_set_id": ["4439286d-2b7b-4403-9e4a-3b0aad10ad5b"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (67939-010-50)", "package_ndc": "67939-010-50", "marketing_start_date": "20200520"}], "brand_name": "Fludeoxyglucose F 18", "product_id": "67939-010_d93db56f-430e-5490-e053-2995a90ace22", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "67939-010", "generic_name": "Fludeoxyglucose F 18", "labeler_name": "The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludeoxyglucose F 18", "active_ingredients": [{"name": "FLUDEOXYGLUCOSE F-18", "strength": "300 mCi/mL"}], "application_number": "ANDA204498", "marketing_category": "ANDA", "marketing_start_date": "20131101", "listing_expiration_date": "20261231"}