fludeoxyglucose f18

Generic: fludeoxyglucose f18

Labeler: the regents of the university of michigan
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludeoxyglucose f18
Generic Name fludeoxyglucose f18
Labeler the regents of the university of michigan
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fludeoxyglucose f-18 300 mCi/mL

Manufacturer
The Regents of the University of Michigan

Identifiers & Regulatory

Product NDC 76326-001
Product ID 76326-001_412331b1-c993-e524-e063-6294a90a444b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204531
Listing Expiration 2026-12-31
Marketing Start 2015-07-17

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 76326001
Hyphenated Format 76326-001

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 f18 (source: ndc)
Generic Name fludeoxyglucose f18 (source: ndc)
Application Number ANDA204531 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mCi/mL
source: ndc
Packaging
  • 19 mL in 1 VIAL, GLASS (76326-001-20)
source: ndc

Packages (1)

76326-001-20 19 mL in 1 VIAL, GLASS (76326-001-20)

Ingredients (1)

fludeoxyglucose f-18 (300 mCi/mL)

Linked Drug Pages (1)

Fludeoxyglucose F18 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "412331b1-c993-e524-e063-6294a90a444b", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["0Z5B2CJX4D"], "spl_set_id": ["35bfa064-4313-49e2-98d2-85a84d2c40a4"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["The Regents of the University of Michigan"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "19 mL in 1 VIAL, GLASS (76326-001-20)", "package_ndc": "76326-001-20", "marketing_start_date": "20150717"}], "brand_name": "Fludeoxyglucose F18", "product_id": "76326-001_412331b1-c993-e524-e063-6294a90a444b", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "76326-001", "generic_name": "Fludeoxyglucose F18", "labeler_name": "The Regents of the University of Michigan", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludeoxyglucose", "brand_name_suffix": "F18", "active_ingredients": [{"name": "FLUDEOXYGLUCOSE F-18", "strength": "300 mCi/mL"}], "application_number": "ANDA204531", "marketing_category": "ANDA", "marketing_start_date": "20150717", "listing_expiration_date": "20261231"}