Sodium FluorideF 18
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: XXXX
Approved
Approval ID
25418092-48c3-4ac0-92b0-72a6289d423f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2011
Manufacturers
FDA
Children's Hospital of Michigan
DUNS: 076377316
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 Code76167-002
Product Classification
G
Generic Name
SODIUM FLUORIDE F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 24, 2011
FDA Product Classification
INGREDIENTS (2)
SODIUM FLUORIDE F-18Active
Quantity: 200 mg in 1 mL
Code: 9L75099X6R
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT