Kit for the Preparation of Technetium Tc 99M Medronate
Kit for the Preparation of Technetium Tc 99m Medronate for Injection
Approved
Approval ID
703d347c-e240-408a-b69d-9713e958a201
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2020
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.
TC 99M MEDRONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45567-0040
Application NumberNDA018124
Product Classification
M
Marketing Category
C73594
G
Generic Name
TC 99M MEDRONATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 1, 2020
FDA Product Classification
INGREDIENTS (3)
STANNOUS FLUORIDEInactive
Quantity: 0.38 mg in 10 mL
Code: 3FTR44B32Q
Classification: IACT
TECHNETIUM TC-99M MEDRONATEActive
Quantity: 20 mg in 10 mL
Code: X89XV46R07
Classification: ACTIR
ASCORBIC ACIDInactive
Quantity: 1 mg in 10 mL
Code: PQ6CK8PD0R
Classification: IACT