NDC 13267-542

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 Feinstein Institute For Medical Research. The primary component is Sodium Fluoride F-18.

Product ID13267-542_293ff570-c5de-4d2a-8bae-f6218b0b9559
NDC13267-542
Product TypeHuman Prescription Drug
Proprietary NameSodium Fluoride F 18
Generic NameSodium Fluoride F 18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-12-02
Marketing CategoryNDA / NDA
Application NumberNDA017042
Labeler NameFEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
Substance NameSODIUM FLUORIDE F-18
Active Ingredient Strength600 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 13267-542-42

20 mL in 1 VIAL, GLASS (13267-542-42)
Marketing Start Date2014-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13267-542-42 [13267054242]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA204328
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-19

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE F-18600 mCi/mL

OpenFDA Data

SPL SET ID:f8afb06c-f4c3-46f0-8f8b-0bc9e072ce47
Manufacturer
UNII

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"

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

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