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Fludeoxyglucose F 18

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2005

Approved
Approval ID

915b1f71-616d-4cd9-90a7-bc556736a3d1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 17, 2020

Manufacturers
FDA

Decatur Memorial Hospital

DUNS: 046584991

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fludeoxyglucose F 18

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73410-003
Application NumberANDA204463
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F 18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 6, 2019
FDA Product Classification

INGREDIENTS (3)

SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
FLUDEOXYGLUCOSE F-18Active
Quantity: 20 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

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Fludeoxyglucose F 18 - FDA Drug Approval Details