NDC 13108-211

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 Spectron Mrc, Llc. The primary component is Sodium Fluoride F-18.

Product ID13108-211_61839182-b613-6b46-e053-2a91aa0a78e3
NDC13108-211
Product TypeHuman Prescription Drug
Proprietary NameSodium Fluoride F 18
Generic NameSodium Fluoride F 18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-04-24
Marketing CategoryANDA / ANDA
Application NumberANDA203912
Labeler NameSpectron mrc, LLC
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 13108-211-10

1 mL in 1 VIAL, GLASS (13108-211-10)
Marketing Start Date2015-04-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13108-211-50 [13108021150]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-24

NDC 13108-211-25 [13108021125]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-24

NDC 13108-211-30 [13108021130]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-24

NDC 13108-211-10 [13108021110]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-24

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE F-18200 mCi/mL

OpenFDA Data

SPL SET ID:16978114-7c7b-0f77-e054-00144ff8d46c
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
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