NDC 16129-002

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 Shertech Laboratories, Llc. The primary component is Sodium Fluoride F-18.

Product ID16129-002_5d8041ed-4731-1859-e053-2991aa0abda3
NDC16129-002
Product TypeHuman Prescription Drug
Proprietary NameSodium Fluoride F 18
Generic NameSodium Fluoride F 18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-03-23
Marketing CategoryANDA / ANDA
Application NumberANDA204315
Labeler NameShertech Laboratories, LLC
Substance NameSODIUM FLUORIDE F-18
Active Ingredient Strength200 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 16129-002-10

10 mL in 1 VIAL, MULTI-DOSE (16129-002-10)
Marketing Start Date2011-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16129-002-10 [16129000210]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA204315
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-23

NDC 16129-002-30 [16129000230]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA204315
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-23

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE F-18200 mCi/mL

OpenFDA Data

SPL SET ID:e93460a9-8c68-4679-aa86-73f47884fd8c
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.