Indium 111 Oxyquinolone
Indium 111 Oxyquinolone (In-111 Oxine)
Approved
Approval ID
eadcaf93-c53e-41b6-aebb-7e7d57f5b303
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 19, 2012
Manufacturers
FDA
AnazaoHealth Corporation
DUNS: 011038762
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Indium 111 Oxyquinolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51808-126
Product Classification
G
Generic Name
Indium 111 Oxyquinolone
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 8, 2012
FDA Product Classification
INGREDIENTS (3)
POLYSORBATE 80Inactive
Quantity: 100 ug in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
INDIUM IN-111 OXYQUINOLINEActive
Quantity: 2 mCi in 1 mL
Code: LGX9OL562T
Classification: ACTIB
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACIDInactive
Quantity: 6 mg in 1 mL
Code: RWW266YE9I
Classification: IACT