NDC 13267-542

Sodium Fluoride F 18

Sodium Fluoride F 18

Sodium Fluoride F 18 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Feinstein Institute For Medical Research. The primary component is Sodium Fluoride F-18.

• Product ID: 13267-542_293ff570-c5de-4d2a-8bae-f6218b0b9559
• NDC: 13267-542
• Product Type: Human Prescription Drug
• Proprietary Name: Sodium Fluoride F 18
• Generic Name: Sodium Fluoride F 18
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-12-02
• Marketing Category: NDA / NDA
• Application Number: NDA017042
• Labeler Name: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• Substance Name: SODIUM FLUORIDE F-18
• Active Ingredient Strength: 600 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 13267-542-42

20 mL in 1 VIAL, GLASS (13267-542-42)

• Marketing Start Date: 2014-11-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13267-542-42 [13267054242]

Sodium Fluoride F 18 INJECTION

• Marketing Category: ANDA
• Application Number: ANDA204328
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-11-19

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE F-18	600 mCi/mL

OpenFDA Data

• SPL SET ID: f8afb06c-f4c3-46f0-8f8b-0bc9e072ce47
• Manufacturer:
  • FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• UNII:
  • 9L75099X6R

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
13108-211	Sodium Fluoride F 18	Sodium Fluoride F 18
24445-623	Sodium Fluoride F 18	SODIUM FLUORIDE F 18
24562-002	Sodium Fluoride F 18	SODIUM FLUORIDE F-18
40028-512	Sodium Fluoride F 18	Sodium Fluoride F 18
49609-102	Sodium Fluoride F 18	SODIUM FLUORIDE F-18
52670-550	Sodium Fluoride F 18	sodium fluoride F 18
60055-623	Sodium Fluoride F 18	Sodium Fluoride F 18
67939-020	Sodium Fluoride F 18	Sodium Fluoride F 18
69126-002	Sodium Fluoride F 18	Sodium Fluoride F 18
73410-002	Sodium Fluoride F 18	Sodium Fluoride F 18
76419-211	Sodium Fluoride F 18	SODIUM FLUORIDE F-18
76451-018	Sodium Fluoride F 18	Sodium Fluoride F 18
24275-0285	Sodium Fluoride F 18	Sodium Fluoride F 18
47584-002	Sodium Fluoride F 18	Sodium Fluoride F 18
51760-002	Sodium Fluoride F 18	Sodium Fluoride F 18
52768-125	Sodium Fluoride F 18	Sodium Fluoride F 18
62072-500	Sodium Fluoride F 18	Sodium Fluoride F 18
49609-002	Sodium Fluoride F 18	Sodium Fluoride F 18
13267-542	Sodium Fluoride	Sodium Fluoride F 18
16129-002	Sodium Fluoride	SODIUM FLUORIDE F 18