Kit for the Preparation of Technetium Tc99m Pyrophosphate
Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection For Diagnostic Use Rx Only
Approved
Approval ID
1f0cbd23-2fb3-43b7-b8af-7de246151149
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 20, 2019
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 139261648
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Technetium Tc99m Pyrophosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45567-0060
Application NumberNDA019039
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc99m Pyrophosphate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 20, 2019
FDA Product Classification
INGREDIENTS (2)
TECHNETIUM TC-99M PYROPHOSPHATEActive
Quantity: 12 mg in 10 mL
Code: 5L76I61H2B
Classification: ACTIR
STANNOUS CHLORIDEInactive
Quantity: 2.8 mg in 10 mL
Code: 1BQV3749L5
Classification: IACT