Glofil-125
Glofil-125
Approved
Approval ID
7f250086-2837-484b-9674-e09856b34cb0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2019
Manufacturers
FDA
Iso-Tex Diagnostics, Inc.
DUNS: 181202995
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Iothalamate I-125 injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50914-7729
Application NumberNDA017279
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium Iothalamate I-125 injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 23, 2018
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IOTHALAMATE SODIUM I-125Active
Quantity: 0.275 mCi in 1 mL
Code: 31J5U3Q9ZN
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT