Kit for the Preparation of Technetium Tc 99m Medronate
Kit for the Preparation of Technetium Tc 99m MedronateFor Diagnostic Use
Approved
Approval ID
54608807-4df6-49ba-b065-59a19ef224c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2021
Manufacturers
FDA
Cardinal Health 414, LLC
DUNS: 069410546
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
technetium tc 99m medronate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65857-505
Application NumberNDA018107
Product Classification
M
Marketing Category
C73594
G
Generic Name
technetium tc 99m medronate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 13, 2020
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TECHNETIUM TC-99M MEDRONATEActive
Quantity: 20 mg in 1 1
Code: X89XV46R07
Classification: ACTIR
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
STANNOUS FLUORIDEInactive
Code: 3FTR44B32Q
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT