NDC 67939-020

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 The University Of Utah Dba Cyclotron Radiochemistry Lab Huntsman Cancer Institute. The primary component is Sodium Fluoride F-18.

• Product ID: 67939-020_95362378-b869-4819-e053-2995a90abd1e
• NDC: 67939-020
• 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: 2012-07-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204497
• Labeler Name: The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute
• Substance Name: SODIUM FLUORIDE F-18
• Active Ingredient Strength: 200 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67939-020-10

10 mL in 1 VIAL, MULTI-DOSE (67939-020-10)

• Marketing Start Date: 2012-07-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67939-020-10 [67939002010]

Sodium Fluoride F 18 INJECTION

• Marketing Category: ANDA
• Application Number: ANDA204497
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-07-11

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE F-18	200 mCi/mL

OpenFDA Data

• SPL SET ID: 2144e4e4-4be5-4fc6-b966-bd525ac7e430
• Manufacturer:
  • The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute
• 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