FDA.reportPublic FDA data

TECHNETIUM Tc 99m MERTIATIDE

Product NDC
65174-261
11-digit product format
651740261
Labeler code
65174
Product ID
65174-261_c7627788-6211-4255-82a9-ec12343149f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Technetium Tc 99m Mertiatide
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Jubilant DraxImage Inc., dba Jubilant Radiopharma
Application
NDA216820
Marketing category
NDA
Marketing start
2023-03-31
Substance
BETIATIDE
Active strength
1 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TECHNETIUM Tc 99m MERTIATIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETIATIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9NV2SR34P8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5af9c324-e5fa-4bce-87db-9843891abc5eProduct name220200617

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65174-261-01TECHNETIUM Tc 99m MERTIATIDE1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,14
65174-261-05TECHNETIUM Tc 99m MERTIATIDE5 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65174-261TECHNETIUM TC 99M MERTIATIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA]4Current NDC, 2 package rows20230331_d497f2a2-8e8d-4372-ba09-f8e6b22d2cf8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65174-261-01651740261011 in 1 VIALHistorical
65174-261-05651740261055 VIAL in 1 CARTON (65174-261-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-261-01) 5 vial2023-03-31NoNoHistorical