MedPath

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69945-030
Application NumberNDA017243
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc-99m
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (1)

TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 3 Ci in 1 1
Code: A0730CX801
Classification: ACTIR

Technetium Tc-99m

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69945-051
Application NumberNDA017243
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc-99m
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (1)

TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 5 Ci in 1 1
Code: A0730CX801
Classification: ACTIR

Technetium Tc-99m

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69945-160
Application NumberNDA017243
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc-99m
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (1)

TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 16 Ci in 1 1
Code: A0730CX801
Classification: ACTIR

Technetium Tc-99m

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69945-110
Application NumberNDA017243
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc-99m
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (1)

TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 11 Ci in 1 1
Code: A0730CX801
Classification: ACTIR

Technetium Tc-99m

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69945-025
Application NumberNDA017243
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc-99m
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (1)

TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 2.5 Ci in 1 1
Code: A0730CX801
Classification: ACTIR

Technetium Tc-99m

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69945-015
Application NumberNDA017243
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc-99m
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (1)

TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 1.5 Ci in 1 1
Code: A0730CX801
Classification: ACTIR

Technetium Tc-99m

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69945-035
Application NumberNDA017243
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc-99m
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (1)

TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 3.5 Ci in 1 1
Code: A0730CX801
Classification: ACTIR

Technetium Tc-99m

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69945-140
Application NumberNDA017243
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc-99m
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (1)

TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 14 Ci in 1 1
Code: A0730CX801
Classification: ACTIR

Technetium Tc-99m

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69945-010
Application NumberNDA017243
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc-99m
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (1)

TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 1 Ci in 1 1
Code: A0730CX801
Classification: ACTIR

Technetium Tc-99m

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69945-060
Application NumberNDA017243
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc-99m
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (1)

TECHNETIUM TC-99M SODIUM PERTECHNETATEActive
Quantity: 6 Ci in 1 1
Code: A0730CX801
Classification: ACTIR

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Ultra-Technekow - FDA Drug Approval Details