NDC 52768-001

Fludeoxyglucose F-18

Fludeoxyglucose F-18

Fludeoxyglucose F-18 is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Precision Nuclear Llc. The primary component is Fludeoxyglucose F-18.

Product ID52768-001_139fb76b-aef1-4aea-e054-00144ff8d46c
NDC52768-001
Product TypeHuman Prescription Drug
Proprietary NameFludeoxyglucose F-18
Generic NameFludeoxyglucose F-18
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-10-10
Marketing CategoryANDA / ANDA
Application NumberANDA204546
Labeler NamePrecision Nuclear LLC
Substance NameFLUDEOXYGLUCOSE F-18
Active Ingredient Strength500 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52768-001-30

30 mL in 1 VIAL (52768-001-30)
Marketing Start Date2010-10-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52768-001-50 [52768000150]

Fludeoxyglucose F-18 INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA204546
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-10

NDC 52768-001-10 [52768000110]

Fludeoxyglucose F-18 INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA204546
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-10
Marketing End Date2011-11-14

NDC 52768-001-30 [52768000130]

Fludeoxyglucose F-18 INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA204546
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-10

NDC 52768-001-05 [52768000105]

Fludeoxyglucose F-18 INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA204546
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-10
Marketing End Date2011-11-14

NDC 52768-001-11 [52768000111]

Fludeoxyglucose F-18 INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA204546
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-10
Marketing End Date2011-11-14

NDC 52768-001-03 [52768000103]

Fludeoxyglucose F-18 INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA204546
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-10
Marketing End Date2011-11-14

Drug Details

Active Ingredients

IngredientStrength
FLUDEOXYGLUCOSE F-18500 mCi/mL

OpenFDA Data

SPL SET ID:09ae2a6d-673a-423a-ba45-3c543061b103
Manufacturer
UNII

Pharmacological Class

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

NDC Crossover Matching brand name "Fludeoxyglucose F-18" or generic name "Fludeoxyglucose F-18"

NDCBrand NameGeneric Name
11994-015Fludeoxyglucose F-18Fludeoxyglucose F-18
16129-001Fludeoxyglucose F-18Fludeoxyglucose F-18
24450-647FLUDEOXYGLUCOSE F-18FLUDEOXYGLUCOSE F-18
24468-001Fludeoxyglucose F-18Fludeoxyglucose F-18 Injection
40098-101Fludeoxyglucose F-18Fludeoxyglucose F-18
52768-001Fludeoxyglucose F-18Fludeoxyglucose F-18
65857-150Fludeoxyglucose F-18Fludeoxyglucose F-18
70681-002Fludeoxyglucose F-18Fludeoxyglucose F-18
78714-001FLUDEOXYGLUCOSE F-18FLUDEOXYGLUCOSE F-18
24562-001FludeoxyglucoseFludeoxyglucose F-18
24417-001FLUDEOXYGLUCOSE F 18FLUDEOXYGLUCOSE F-18
29998-001Fludeoxyglucose F 18Fludeoxyglucose F-18
49609-101Fludeoxyglucose F 18Fludeoxyglucose F-18
52670-551Fludeoxyglucose F 18Fludeoxyglucose F-18
60055-334Fludeoxyglucose F 18Fludeoxyglucose F-18
24562-003Fludeoxyglucose F18Fludeoxyglucose F-18
44338-001Fludeoxyglucose F18Fludeoxyglucose F-18
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