Technetium Tc 99m Medronate
Approved
Approval ID
3c91d0d8-6cc5-834c-bda0-aa83a873b9fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2020
Manufacturers
FDA
Jubilant DraxImage Inc., dba Jubilant Radiopharma
DUNS: 243604761
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 Code65174-660
Application NumberNDA018035
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc 99m Medronate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 17, 2018
FDA Product Classification
INGREDIENTS (3)
MEDRONIC ACIDActive
Quantity: 25 mg in 1 1
Code: 73OS0QIN3O
Classification: ACTIB
Stannous ChlorideInactive
Quantity: 2.0 mg in 1 1
Code: 1BQV3749L5
Classification: IACT
Aminobenzoic AcidInactive
Quantity: 5.0 mg in 1 1
Code: TL2TJE8QTX
Classification: IACT