NDC 49609-102

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 Sofie Co.. The primary component is Sodium Fluoride F-18.

Product ID49609-102_44793a2a-9eb4-45f5-832e-bc0fb60156c7
NDC49609-102
Product TypeHuman Prescription Drug
Proprietary NameSodium Fluoride F 18
Generic NameSodium Fluoride F-18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-12-08
Marketing CategoryANDA / ANDA
Application NumberANDA203592
Labeler NameSOFIE Co.
Substance NameSODIUM FLUORIDE F-18
Active Ingredient Strength200 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49609-102-01

30 mL in 1 VIAL, MULTI-DOSE (49609-102-01)
Marketing Start Date2011-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49609-102-01 [49609010201]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203592
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-12-08

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE F-18200 mCi/mL

OpenFDA Data

SPL SET ID:2bbd8f48-fdf9-45cb-8305-124a03f7a52c
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
76451-018Sodium Fluoride F 18Sodium Fluoride F 18
76419-211Sodium Fluoride F 18Sodium Fluoride F 18
13267-542Sodium FluorideSodium Fluoride F 18
16129-002Sodium FluorideSODIUM FLUORIDE F 18
24275-0285Sodium FluorideSodium Fluoride F-18
47584-002Sodium FluorideSODIUM FLUORIDE F-18
49609-002Sodium FluorideSODIUM FLUORIDE F-18
51760-002Sodium FluorideSODIUM FLUORIDE F-18
52768-125Sodium FluorideSODIUM FLUORIDE F-18
62072-500Sodium FluorideSODIUM FLUORIDE F-18
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