FLUDEOXYGLUCOSE F18 injection, solution

Fludeoxyglucose F18 by

Drug Labeling and Warnings

Fludeoxyglucose F18 by is a Prescription medication manufactured, distributed, or labeled by The Methodist Hospital Research Institute. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

DOSAGE FORMS & STRENGTHS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

DESCRIPTION

CLINICAL PHARMACOLOGY

NONCLINICAL TOXICOLOGY

CLINICAL STUDIES

REFERENCES

HOW SUPPLIED

PATIENT MEDICATION INFORMATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLUDEOXYGLUCOSE F18 
fludeoxyglucose f18 injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69864-001
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUDEOXYGLUCOSE F-18 (UNII: 0Z5B2CJX4D) (FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D)	FLUDEOXYGLUCOSE F-18	0.3 Ci  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69864-001-30	30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product	04/23/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203904	04/23/2012

Labeler - The Methodist Hospital Research Institute (185641052)

Registrant - The Methodist Hospital Research Institute (185641052)

Establishment
Name	Address	ID/FEI	Business Operations
The Methodist Hospital Research Institute		185641052	positron emission tomography drug production(69864-001)