NDC 69126-004

Choline C 11

Choline C11

Choline C 11 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Global Isotopes, Llc D/b/a Zevacor Molecular. The primary component is Choline C-11.

Product ID69126-004_5d7fc9e5-163d-edc8-e053-2a91aa0a934e
NDC69126-004
Product TypeHuman Prescription Drug
Proprietary NameCholine C 11
Generic NameCholine C11
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA206319
Labeler NameGlobal Isotopes, LLC d/b/a Zevacor Molecular
Substance NameCHOLINE C-11
Active Ingredient Strength4 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69126-004-01

30 mL in 1 VIAL, MULTI-DOSE (69126-004-01)
Marketing Start Date2017-11-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69126-004-01 [69126000401]

Choline C 11 INJECTION
Marketing CategoryANDA
Application NumberANDA206319
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-14
Marketing End Date2019-05-17

Drug Details

Active Ingredients

IngredientStrength
CHOLINE C-114 mCi/mL

OpenFDA Data

SPL SET ID:04ae6f89-aa78-42c2-ab28-7685852346ab
Manufacturer
UNII

Pharmacological Class

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

NDC Crossover Matching brand name "Choline C 11" or generic name "Choline C11"

NDCBrand NameGeneric Name
24275-0485Choline C 11Choline C-11
52670-556Choline C 11Choline C-11
60215-111Choline C 11Choline C 11
69126-004Choline C 11Choline C11
73410-004Choline C 11Choline C 11
75913-311Choline C 11Choline C-11

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