NDC 52670-550

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 Mayo Clinic. The primary component is Sodium Fluoride F-18.

Product ID52670-550_b26e7cbe-3c39-4bf4-a78d-c9f9a52dbbd0
NDC52670-550
Product TypeHuman Prescription Drug
Proprietary NameSodium Fluoride F 18
Generic NameSodium Fluoride F 18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2013-06-28
Marketing CategoryANDA / ANDA
Application NumberANDA203605
Labeler NameMayo Clinic
Substance NameSODIUM FLUORIDE F-18
Active Ingredient Strength92 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52670-550-30

30 mL in 1 VIAL, MULTI-DOSE (52670-550-30)
Marketing Start Date2013-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52670-550-30 [52670055030]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203605
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-06-28

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE F-1891.5 mCi/mL

OpenFDA Data

SPL SET ID:e435568c-f8d2-4cee-aceb-c68b277ad8f5
Manufacturer
UNII

Pharmacological Class

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

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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.