Ultra-Technekow
Ultra-Technekow V4 (Technetium Tc 99m Generator) Rx only For the Production of Sodium Pertechnetate Tc 99m Injection
Approved
Approval ID
98947d99-5be5-461e-ad36-7425d3646389
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 9, 2022
Manufacturers
FDA
Curium US LLC
DUNS: 079875617
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Technetium Tc-99m
PRODUCT DETAILS
NDC Product Code69945-030
Application NumberNDA017243
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
Generic NameTechnetium Tc-99m
INGREDIENTS (1)
TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 3 Ci in 1 1
Code: A0730CX801
Classification: ACTIR
Technetium Tc-99m
PRODUCT DETAILS
NDC Product Code69945-051
Application NumberNDA017243
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
Generic NameTechnetium Tc-99m
INGREDIENTS (1)
TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 5 Ci in 1 1
Code: A0730CX801
Classification: ACTIR
Technetium Tc-99m
PRODUCT DETAILS
NDC Product Code69945-160
Application NumberNDA017243
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
Generic NameTechnetium Tc-99m
INGREDIENTS (1)
TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 16 Ci in 1 1
Code: A0730CX801
Classification: ACTIR
Technetium Tc-99m
PRODUCT DETAILS
NDC Product Code69945-110
Application NumberNDA017243
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
Generic NameTechnetium Tc-99m
INGREDIENTS (1)
TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 11 Ci in 1 1
Code: A0730CX801
Classification: ACTIR
Technetium Tc-99m
PRODUCT DETAILS
NDC Product Code69945-025
Application NumberNDA017243
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
Generic NameTechnetium Tc-99m
INGREDIENTS (1)
TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 2.5 Ci in 1 1
Code: A0730CX801
Classification: ACTIR
Technetium Tc-99m
PRODUCT DETAILS
NDC Product Code69945-015
Application NumberNDA017243
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
Generic NameTechnetium Tc-99m
INGREDIENTS (1)
TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 1.5 Ci in 1 1
Code: A0730CX801
Classification: ACTIR
Technetium Tc-99m
PRODUCT DETAILS
NDC Product Code69945-035
Application NumberNDA017243
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
Generic NameTechnetium Tc-99m
INGREDIENTS (1)
TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 3.5 Ci in 1 1
Code: A0730CX801
Classification: ACTIR
Technetium Tc-99m
PRODUCT DETAILS
NDC Product Code69945-140
Application NumberNDA017243
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
Generic NameTechnetium Tc-99m
INGREDIENTS (1)
TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 14 Ci in 1 1
Code: A0730CX801
Classification: ACTIR
Technetium Tc-99m
PRODUCT DETAILS
NDC Product Code69945-010
Application NumberNDA017243
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
Generic NameTechnetium Tc-99m
INGREDIENTS (1)
TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 1 Ci in 1 1
Code: A0730CX801
Classification: ACTIR
Technetium Tc-99m
PRODUCT DETAILS
NDC Product Code69945-060
Application NumberNDA017243
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
Generic NameTechnetium Tc-99m
INGREDIENTS (1)
TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 6 Ci in 1 1
Code: A0730CX801
Classification: ACTIR