NDC 69126-002

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 Global Isotopes, Llc D/b/a Zevacor Molecular. The primary component is Fluoride Ion F-18.

• Product ID: 69126-002_5d8f7089-c735-9a24-e053-2a91aa0a83df
• NDC: 69126-002
• 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: 2014-10-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204464
• Labeler Name: Global Isotopes, LLC d/b/a Zevacor Molecular
• Substance Name: FLUORIDE ION F-18
• Active Ingredient Strength: 10 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69126-002-01

30 mL in 1 VIAL, MULTI-DOSE (69126-002-01)

• Marketing Start Date: 2014-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69126-002-01 [69126000201]

Sodium Fluoride F 18 INJECTION

• Marketing Category: ANDA
• Application Number: ANDA204464
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-10-31
• Marketing End Date: 2019-05-17

Drug Details

Active Ingredients

Ingredient	Strength
FLUORIDE ION F-18	10 mCi/mL

OpenFDA Data

• SPL SET ID: d5aa1922-4766-4479-bcb9-010d679478cc
• Manufacturer:
  • Global Isotopes, LLC d/b/a Zevacor Molecular
• UNII:
  • 4M4WE5N2GE

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