MedPath

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

NDC Product Code11994-090
Application NumberNDA017771
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJanuary 31, 2023
Generic NameTechnetium Tc99m Generator

INGREDIENTS (1)

TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 250 mCi in 1 mL
Code: A0730CX801
Classification: ACTIR

Technetium Tc99m Generator

PRODUCT DETAILS

NDC Product Code11994-091
Application NumberNDA017771
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJanuary 31, 2023
Generic NameTechnetium Tc99m Generator

INGREDIENTS (1)

TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 250 mCi in 1 mL
Code: A0730CX801
Classification: ACTIR

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TechneLite - FDA Drug Approval Details