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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 FLOURIDE F 18 INJECTION USP, for Intravenous Use Initial U.S. Approval: 1/2011

Approved
Approval ID

d834721b-b624-4b27-9009-95e09827122e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 23, 2022

Manufacturers
FDA

Precision Nuclear LLC

DUNS: 879283633

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 Code52768-125
Application NumberANDA204542
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM FLUORIDE F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 23, 2022
FDA Product Classification

INGREDIENTS (2)

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

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Sodium Fluoride - FDA Drug Approval Details