NDC 49609-101

Fludeoxyglucose F 18

Fludeoxyglucose F-18

Fludeoxyglucose F 18 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sofie Co.. The primary component is Fludeoxyglucose F-18.

Product ID49609-101_4cdf6f75-cd5e-4aa2-ac53-4b5de0963131
NDC49609-101
Product TypeHuman Prescription Drug
Proprietary NameFludeoxyglucose F 18
Generic NameFludeoxyglucose F-18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-12-08
Marketing CategoryANDA / ANDA
Application NumberANDA203591
Labeler NameSOFIE Co.
Substance NameFLUDEOXYGLUCOSE F-18
Active Ingredient Strength300 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49609-101-01

30 mL in 1 VIAL, MULTI-DOSE (49609-101-01)
Marketing Start Date2011-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49609-101-02 [49609010102]

Fludeoxyglucose F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203591
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-08

NDC 49609-101-01 [49609010101]

Fludeoxyglucose F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203591
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-08

Drug Details

Active Ingredients

IngredientStrength
FLUDEOXYGLUCOSE F-18300 mCi/mL

OpenFDA Data

SPL SET ID:2028be0c-333c-4e0c-be57-099276c725d7
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
13108-111Fludeoxyglucose F 18Fludeoxyglucose F 18
21731-647Fludeoxyglucose F 18Fludeoxyglucose F 18
24417-001FLUDEOXYGLUCOSE F 18FLUDEOXYGLUCOSE F-18
24445-334Fludeoxyglucose F 18Fludeoxyglucose F 18
29998-001Fludeoxyglucose F 18Fludeoxyglucose F-18
40028-511Fludeoxyglucose F 18Fludeoxyglucose F 18
49609-101Fludeoxyglucose F 18Fludeoxyglucose F-18
52670-551Fludeoxyglucose F 18Fludeoxyglucose F-18
67939-010Fludeoxyglucose F 18Fludeoxyglucose F 18
69126-003Fludeoxyglucose F 18Fludeoxyglucose F 18
75913-647Fludeoxyglucose F 18Fludeoxyglucose F 18
72634-001Fludeoxyglucose F 18Fludeoxyglucose F 18
76167-001Fludeoxyglucose F 18Fludeoxyglucose F 18
76394-3811Fludeoxyglucose F 18Fludeoxyglucose F 18
76376-618Fludeoxyglucose F 18Fludeoxyglucose F 18
76419-111Fludeoxyglucose F 18Fludeoxyglucose F 18
76318-334Fludeoxyglucose F 18Fludeoxyglucose F 18
60055-334Fludeoxyglucose F 18Fludeoxyglucose F 18
73410-003Fludeoxyglucose F 18Fludeoxyglucose F 18
24562-001FludeoxyglucoseFludeoxyglucose F-18
11994-015Fludeoxyglucose F-18Fludeoxyglucose F-18
16129-001Fludeoxyglucose F-18Fludeoxyglucose F-18
24450-647FLUDEOXYGLUCOSE F-18FLUDEOXYGLUCOSE F-18
40098-101Fludeoxyglucose F-18Fludeoxyglucose F-18
52768-001Fludeoxyglucose F-18Fludeoxyglucose F-18
24562-003Fludeoxyglucose F18Fludeoxyglucose F-18
44338-001Fludeoxyglucose F18Fludeoxyglucose F-18

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