NDC 76451-118

Fludeoxyglucose F18

Fludeoxyglucose F18

Fludeoxyglucose F18 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by 3d Imaging Drug Design And Development Llc. The primary component is Fludeoxyglucose F-18.

Product ID76451-118_08281fe0-a1d7-481e-95a8-b7043e88ba48
NDC76451-118
Product TypeHuman Prescription Drug
Proprietary NameFludeoxyglucose F18
Generic NameFludeoxyglucose F18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA203778
Labeler Name3D Imaging Drug Design and Development LLC
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 76451-118-10

10 mL in 1 VIAL, GLASS (76451-118-10)
Marketing Start Date2018-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76451-118-11 [76451011811]

Fludeoxyglucose F18 INJECTION
Marketing CategoryANDA
Application NumberANDA203778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-17

NDC 76451-118-30 [76451011830]

Fludeoxyglucose F18 INJECTION
Marketing CategoryANDA
Application NumberANDA203778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-17

NDC 76451-118-51 [76451011851]

Fludeoxyglucose F18 INJECTION
Marketing CategoryANDA
Application NumberANDA203778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-17

NDC 76451-118-10 [76451011810]

Fludeoxyglucose F18 INJECTION
Marketing CategoryANDA
Application NumberANDA203778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-17

Drug Details

Active Ingredients

IngredientStrength
FLUDEOXYGLUCOSE F-18300 mCi/mL

OpenFDA Data

SPL SET ID:2785ce60-86c9-42c2-ab0a-8c5d5adf60d3
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

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