NDC 13108-111

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 Spectron Mrc, Llc. The primary component is Fludeoxyglucose F-18.

Product ID13108-111_61839182-b614-6b46-e053-2a91aa0a78e3
NDC13108-111
Product TypeHuman Prescription Drug
Proprietary NameFludeoxyglucose F 18
Generic NameFludeoxyglucose F 18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-04-24
Marketing CategoryANDA / ANDA
Application NumberANDA203911
Labeler NameSpectron mrc, 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 13108-111-10

1 mL in 1 VIAL, GLASS (13108-111-10)
Marketing Start Date2015-04-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13108-111-50 [13108011150]

Fludeoxyglucose F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203911
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-24

NDC 13108-111-10 [13108011110]

Fludeoxyglucose F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203911
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-24

NDC 13108-111-25 [13108011125]

Fludeoxyglucose F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203911
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-24

NDC 13108-111-30 [13108011130]

Fludeoxyglucose F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203911
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-24

Drug Details

Active Ingredients

IngredientStrength
FLUDEOXYGLUCOSE F-18500 mCi/mL

OpenFDA Data

SPL SET ID:15e469a5-8309-0c25-e054-00144ff88e88
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
60055-334Fludeoxyglucose F 18Fludeoxyglucose F-18
67939-010Fludeoxyglucose F 18Fludeoxyglucose F 18
69126-003Fludeoxyglucose F 18Fludeoxyglucose F 18
72634-001Fludeoxyglucose F 18Fludeoxyglucose F 18 Injection
73410-003Fludeoxyglucose F 18Fludeoxyglucose F 18
75913-647Fludeoxyglucose 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

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