Choline C 11
These highlights do not include all the information needed to use Choline C 11 Injection safely and effectively. See full prescribing information for Choline C 11 Injection . Choline C 11 Injection , for intravenous use Initial U.S. Approval: 2012
Approved
Approval ID
8e046642-5038-4094-b1bb-a1915558fb1c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Mayo Clinic
DUNS: 167141923
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Choline C-11
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52670-556
Application NumberNDA203155
Product Classification
M
Marketing Category
C73594
G
Generic Name
Choline C-11
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CHOLINE C-11Active
Quantity: 33.1 mCi in 1 mL
Code: M4AS4XGD4Q
Classification: ACTIB