Ga-68-DOTATOC
These highlights do not include all the information needed to use Ga 68 DOTATOC INJECTION safely and effectively. See full prescribing information for Ga 68 DOTATOC INJECTION. Ga 68 DOTATOC Injection, for intravenous use Initial U.S. Approval: 2019
Approved
Approval ID
c4d185c3-d520-462d-ba50-4f4ee485ace3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2021
Manufacturers
FDA
UIHC – P E T Imaging Center
DUNS: 063513265
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
EDOTREOTIDE GALLIUM GA-68
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24417-681
Application NumberNDA210828
Product Classification
M
Marketing Category
C73594
G
Generic Name
EDOTREOTIDE GALLIUM GA-68
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 8, 2021
FDA Product Classification
INGREDIENTS (3)
EDOTREOTIDE GALLIUM GA-68Active
Quantity: 4 mCi in 1 mL
Code: Y68179SY2L
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT