Kit for the Preparation of Technetium Tc 99m Sulfur Colloid

Product NDC
65174-179
11-digit product format
651740179
Labeler code
65174
Product ID
65174-179_92a1bc37-cc23-4498-ad61-29347c3876dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Technetium Tc 99m Sulfur Colloid Kit
Dosage form
KIT
Labeler
Jubilant DraxImage Inc., dba Jubilant Radiopharma
Application
ANDA213516
Marketing category
ANDA
Marketing start
2023-12-04
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid
Listing expiration
2026-12-31

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65174-179-01Kit for the Preparation of Technetium Tc 99m Sulfur Colloid1 in 1 PACKAGEKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65174-179KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SULFUR COLLOID (TECHNETIUM TC 99M SULFUR COLLOID KIT) KIT [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA]6Current NDC, 1 package rows20231207_f756e00e-0acd-4c5d-97f8-ed57f23a2393.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65174-179-01651740179011 KIT in 1 PACKAGE (65174-179-01) * 3 mL in 1 VIAL (65174-046-01) * 3 mL in 1 VIAL (65174-047-01) * 10 mL in 1 VIAL (65174-131-01) 1 kit2023-12-04NoNoCurrent