NDC 76419-211

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 Hot Shots Nm, Llc Dba Midwest Positron Technology, Lc. The primary component is Sodium Fluoride F-18.

Product ID76419-211_99e70a20-1679-16e4-e053-2995a90a80a4
NDC76419-211
Product TypeHuman Prescription Drug
Proprietary NameSodium Fluoride F 18
Generic NameSodium Fluoride F-18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-08-21
Marketing CategoryANDA / ANDA
Application NumberANDA204530
Labeler NameHot Shots NM, LLC dba Midwest Positron Technology, LC
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 76419-211-10

10 mL in 1 VIAL, GLASS (76419-211-10)
Marketing Start Date2014-08-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76419-211-25 [76419021125]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA204530
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-21

NDC 76419-211-50 [76419021150]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA204530
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-21

NDC 76419-211-30 [76419021130]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA204530
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-21

NDC 76419-211-10 [76419021110]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA204530
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-21

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE F-18200 mCi/mL

OpenFDA Data

SPL SET ID:20d9b74e-e3d8-4511-9df9-cec2087372fc
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
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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