NDC 16129-001

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 Shertech Laboratories, Llc. The primary component is Fludeoxyglucose F-18.

Product ID16129-001_5d7f637a-24f9-6a3e-e053-2991aa0a6dd6
NDC16129-001
Product TypeHuman Prescription Drug
Proprietary NameFludeoxyglucose F-18
Generic NameFludeoxyglucose F-18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2006-03-29
Marketing CategoryANDA / ANDA
Application NumberANDA204264
Labeler NameShertech Laboratories, LLC
Substance NameFLUDEOXYGLUCOSE F-18
Active Ingredient Strength300 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 16129-001-10

10 mL in 1 VIAL, MULTI-DOSE (16129-001-10)
Marketing Start Date2006-03-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16129-001-30 [16129000130]

Fludeoxyglucose F-18 INJECTION
Marketing CategoryANDA
Application NumberANDA204264
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-03-29

NDC 16129-001-10 [16129000110]

Fludeoxyglucose F-18 INJECTION
Marketing CategoryANDA
Application NumberANDA204264
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-03-29

Drug Details

Active Ingredients

IngredientStrength
FLUDEOXYGLUCOSE F-18300 mCi/mL

OpenFDA Data

SPL SET ID:3535020f-26c3-40b8-bdb5-1aaa1857ba57
Manufacturer
UNII

Pharmacological Class

  • 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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