NDC 47584-001

Fludeoxyglucose F18

Fludeoxyglucose F18

Fludeoxyglucose F18 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Houston Cyclotron Partners Lp Dba Cyclotope. The primary component is Fludeoxyglucose F-18.

Product ID47584-001_7cd73e9d-7be9-50b8-e053-2991aa0a152d
NDC47584-001
Product TypeHuman Prescription Drug
Proprietary NameFludeoxyglucose F18
Generic NameFludeoxyglucose F18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-12-08
Marketing CategoryANDA / ANDA
Application NumberANDA203665
Labeler NameHouston Cyclotron Partners LP dba Cyclotope
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 47584-001-01

16 mL in 1 VIAL, GLASS (47584-001-01)
Marketing Start Date2011-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47584-001-01 [47584000101]

Fludeoxyglucose F18 INJECTION
Marketing CategoryANDA
Application NumberANDA203665
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-12-08
Marketing End Date2020-05-12

Drug Details

Active Ingredients

IngredientStrength
FLUDEOXYGLUCOSE F-18500 mCi/mL

OpenFDA Data

SPL SET ID:e3f039f5-efd3-423f-891e-90654951d03b
Manufacturer
UNII

Pharmacological Class

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

NDC Crossover Matching brand name "Fludeoxyglucose F18" or generic name "Fludeoxyglucose F18"

NDCBrand NameGeneric Name
13267-123Fludeoxyglucose F18Fludeoxyglucose F18
24275-0185Fludeoxyglucose F18Fludeoxyglucose F18
24562-003Fludeoxyglucose F18Fludeoxyglucose F-18
44338-001Fludeoxyglucose F18Fludeoxyglucose F-18
51760-001Fludeoxyglucose F18Fludeoxyglucose F18
69815-754Fludeoxyglucose F18Fludeoxyglucose F18
69864-001Fludeoxyglucose F18Fludeoxyglucose F18
81365-001FLUDEOXYGLUCOSE F18FLUDEOXYGLUCOSE F-18
24562-001Fludeoxyglucose F18Fludeoxyglucose F18
13267-234FludeoxyglucoseFludeoxyglucose F18
47584-001FludeoxyglucoseFludeoxyglucose F18
49609-001FludeoxyglucoseFludeoxyglucose F18
60215-411FludeoxyglucoseFludeoxyglucose F18
62072-008FludeoxyglucoseFludeoxyglucose F18
69587-001FludeoxyglucoseFludeoxyglucose F18
76326-001FludeoxyglucoseFludeoxyglucose F18
76451-118FludeoxyglucoseFludeoxyglucose F18
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