Choline C 11
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2012
Approved
Approval ID
e817ab8b-ba2c-4226-b37f-c6d75e4d94cd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2019
Manufacturers
FDA
Decatur Memorial Hospital
DUNS: 046584991
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 Code73410-004
Application NumberANDA206319
Product Classification
M
Marketing Category
C73584
G
Generic Name
Choline C 11
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 6, 2019
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CHOLINE C-11Active
Quantity: 4 mCi in 1 mL
Code: M4AS4XGD4Q
Classification: ACTIB