NDC 47584-002

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 Houston Cyclotron Partners Lp Dba Cyclotope. The primary component is Sodium Fluoride F-18.

• Product ID: 47584-002_7cda8776-f781-1eea-e053-2a91aa0ae22e
• NDC: 47584-002
• 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: 2011-12-08
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203544
• Labeler Name: Houston Cyclotron Partners LP dba Cyclotope
• 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: 2019-12-31

Packaging

NDC 47584-002-01

30 mL in 1 VIAL, GLASS (47584-002-01)

• Marketing Start Date: 2011-12-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47584-002-01 [47584000201]

Sodium Fluoride F 18 INJECTION

• Marketing Category: ANDA
• Application Number: ANDA203544
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-12-08
• Marketing End Date: 2020-05-11
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-05-13

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE F-18	200 mCi/mL

OpenFDA Data

• SPL SET ID: e8e24d05-1222-4d06-afb8-27b184428bb4
• Manufacturer:
  • Houston Cyclotron Partners LP dba Cyclotope
• 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
76451-018	Sodium Fluoride F 18	Sodium Fluoride F 18
76419-211	Sodium Fluoride F 18	Sodium Fluoride F 18
13267-542	Sodium Fluoride	Sodium Fluoride F 18
16129-002	Sodium Fluoride	SODIUM FLUORIDE F 18
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