NDC 65857-300

Sodium Fluoride F18

Sodium Fluoride F18

Sodium Fluoride F18 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health 414, Llc. The primary component is Sodium Fluoride F-18.

Product ID65857-300_56810233-d952-4904-a3e9-c3dc3aa480e6
NDC65857-300
Product TypeHuman Prescription Drug
Proprietary NameSodium Fluoride F18
Generic NameSodium Fluoride F18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-07-30
Marketing CategoryANDA / ANDA
Application NumberANDA203780
Labeler NameCardinal Health 414, 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 65857-300-30

30 mL in 1 VIAL, GLASS (65857-300-30)
Marketing Start Date2015-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65857-300-30 [65857030030]

Sodium Fluoride F18 INJECTION
Marketing CategoryANDA
Application NumberANDA203780
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-30

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE F-18200 mCi/mL

OpenFDA Data

SPL SET ID:96e61ba1-30ca-4844-b503-056afd247e69
Manufacturer
UNII

Pharmacological Class

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

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