NDC 60055-623

Sodium Fluoride F 18

Sodium Fluoride F 18

Sodium Fluoride F 18 is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Jubilant Drax Image Radiopharmacies, Inc. Dba Jubilant Radiopharma. The primary component is Sodium Fluoride F-18.

• Product ID: 60055-623_11315b95-d5f0-4960-98e6-43fcf54daeb7
• NDC: 60055-623
• Product Type: Human Prescription Drug
• Proprietary Name: Sodium Fluoride F 18
• Generic Name: Sodium Fluoride F 18
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-01-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203968
• Labeler Name: JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA JUBILANT RADIOPHARMA
• 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: 2023-12-31

Packaging

NDC 60055-623-30

30 mL in 1 VIAL (60055-623-30)

• Marketing Start Date: 2015-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60055-623-30 [60055062330]

Sodium Fluoride F 18 INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA203968
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-09-01

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE F-18	200 mCi/mL

OpenFDA Data

• SPL SET ID: 1ab87313-f82a-4819-9e32-f1320a747fef
• Manufacturer:
  • JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA TRIAD ISOTOPES
• 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