NDC 76167-002

Sodium FluorideF 18 F 18

Sodium Fluoride F-18

Sodium FluorideF 18 F 18 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Children's Hospital Of Michigan. The primary component is Sodium Fluoride F-18.

• Product ID: 76167-002_c849e41b-ab04-4c4b-a055-57e87ce42915
• NDC: 76167-002
• Product Type: Human Prescription Drug
• Proprietary Name: Sodium FluorideF 18 F 18
• Generic Name: Sodium Fluoride F-18
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-06-12
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Children's Hospital of Michigan
• Substance Name: SODIUM FLUORIDE F-18
• Active Ingredient Strength: 200 mg/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 76167-002-30

30 mL in 1 VIAL, MULTI-DOSE (76167-002-30)

• Marketing Start Date: 2012-06-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76167-002-30 [76167000230]

Sodium FluorideF 18 F 18 INJECTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-06-12
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE F-18	200 mg/mL

OpenFDA Data

• SPL SET ID: 25418092-48c3-4ac0-92b0-72a6289d423f
• Manufacturer:
  • Children's Hospital of Michigan
• UNII:
  • 9L75099X6R

Pharmacological Class

• Radioactive Diagnostic Agent [EPC]
• Radiopharmaceutical Activity [MoA]

NDC Crossover Matching brand name "Sodium FluorideF 18 F 18" or generic name "Sodium Fluoride F-18"

NDC	Brand Name	Generic Name
24275-0285	Sodium Fluoride	Sodium Fluoride F-18
47584-002	Sodium Fluoride	SODIUM FLUORIDE F-18
49609-002	Sodium Fluoride	SODIUM FLUORIDE F-18
51760-002	Sodium Fluoride	SODIUM FLUORIDE F-18
52768-125	Sodium Fluoride	SODIUM FLUORIDE F-18
62072-500	Sodium Fluoride	SODIUM FLUORIDE F-18
76451-018	Sodium Fluoride	SODIUM FLUORIDE F-18
81759-002	Sodium Fluoride	SODIUM FLUORIDE F-18
24562-002	Sodium Fluoride F 18	SODIUM FLUORIDE F-18
49609-102	Sodium Fluoride F 18	SODIUM FLUORIDE F-18
76419-211	Sodium Fluoride F 18	SODIUM FLUORIDE F-18
76167-002	Sodium FluorideF 18	SODIUM FLUORIDE F-18