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Sodium Fluoride

These highlights do not include all the information needed to use Sodium Fluoride F 18 Injection safely and effectively. See full prescribing information for Sodium Fluoride F 18 Injection. SODIUM FLUORIDE F 18 INJECTION For Intravenous Use Initial U.S. Approval: 2016

Approved
Approval ID

df1389d2-1b9b-4327-856e-5ba38118d389

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2024

Manufacturers
FDA

Kreitchman PET Center

DUNS: 010861487

Products 1

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

SODIUM FLUORIDE F-18

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62072-500
Application NumberANDA203936
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM FLUORIDE F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 24, 2016
FDA Product Classification

INGREDIENTS (2)

SODIUM FLUORIDE F-18Active
Quantity: 200 mCi in 1 mL
Code: 9L75099X6R
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

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Sodium Fluoride - FDA Drug Approval Details