INDIUM IN 111 CHLORIDE
Diagnostic - For use only in radiolabeling ProstaScint™ (Capromab Pendetide). Radioimmunotherapy - For use only in radiolabeling Zevalin™ (Ibritumomab Tiuxetan).
Approved
Approval ID
e07e66ef-fb9e-4f9f-b63f-ab28f622cb2e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2019
Manufacturers
FDA
Curium US LLC
DUNS: 079875617
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
indium in 111 chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69945-132
Application NumberNDA019841
Product Classification
M
Marketing Category
C73594
G
Generic Name
indium in 111 chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 19, 2019
FDA Product Classification
INGREDIENTS (2)
INDIUM CHLORIDE IN-111Active
Quantity: 10 mCi in 1 mL
Code: 58TD96H03I
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT