CERETEC
Ceretec™ N109A Kit for the Preparation of Technetium Tc99m Exametazime Injection
Approved
Approval ID
3c1eca7e-57a0-4876-8ed6-cd655ef5e296
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Medi-Physics Inc. dba GE Healthcare.
DUNS: 095263729
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TECHNETIUM TC-99M EXAMETAZIME
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17156-022
Application NumberNDA019829
Product Classification
M
Marketing Category
C73594
G
Generic Name
TECHNETIUM TC-99M EXAMETAZIME
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2018
FDA Product Classification
INGREDIENTS (4)
TECHNETIUM TC-99M EXAMETAZIMEActive
Quantity: 0.5 mg in 5 mL
Code: 3B744AG22N
Classification: ACTIR
Stannous ChlorideInactive
Quantity: 7.6 ug in 5 mL
Code: 1BQV3749L5
Classification: IACT
NitrogenInactive
Code: N762921K75
Classification: IACT
Sodium ChlorideInactive
Quantity: 4.0 mg in 5 mL
Code: 451W47IQ8X
Classification: IACT