TECHNETIUM Tc 99m MERTIATIDE
These highlights do not include all the information needed to use KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MERTIATIDE safely and effectively. See full prescribing information for Kit for the preparation of Technetium Tc 99m Mertiatide. KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MERTIATIDE, for intravenous useInitial U.S. Approval: 1990
Approved
Approval ID
d497f2a2-8e8d-4372-ba09-f8e6b22d2cf8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2023
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 Mertiatide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65174-261
Application NumberNDA216820
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technetium Tc 99m Mertiatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 20, 2022
FDA Product Classification
INGREDIENTS (5)
BETIATIDEActive
Quantity: 1 mg in 1 1
Code: 9NV2SR34P8
Classification: ACTIB
STANNOUS CHLORIDEInactive
Quantity: 0.2 mg in 1 1
Code: 1BQV3749L5
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LACTOSE MONOHYDRATEInactive
Quantity: 20 mg in 1 1
Code: EWQ57Q8I5X
Classification: IACT
SODIUM TARTRATE DIHYDRATEInactive
Quantity: 40 mg in 1 1
Code: DIA7C37AOW
Classification: IACT