TechneLite
TechneLite Technetium Tc 99m Generator
Approved
Approval ID
3ae14c6b-3daf-4dd1-bbdb-e990fe8100e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
Lantheus Medical Imaging, Inc.
DUNS: 176786812
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Technetium Tc99m Generator
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11994-090
Application NumberNDA017771
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc99m Generator
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (1)
TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 250 mCi in 1 mL
Code: A0730CX801
Classification: ACTIR
Technetium Tc99m Generator
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11994-091
Application NumberNDA017771
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc99m Generator
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (1)
TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 250 mCi in 1 mL
Code: A0730CX801
Classification: ACTIR