Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)

Product NDC
65857-425
11-digit product format
658570425
Labeler code
65857
Product ID
65857-425_9a68964f-0f50-414d-a7c9-29b6677df463
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tilmanocept
Dosage form
KIT
Labeler
Cardinal Health 414, LLC
Application
NDA202207
Marketing category
NDA
Marketing start
2017-09-20
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 Lymphoseek (technetium Tc 99m tilmanocept)
Listing expiration
2026-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65857-425-05Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)1 in 1 CARTONKIT17
65857-425-05Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)1 in 1 KITKIT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65857-425-05EA - Each65857-425dcbbb543-87fd-47dc-ba1f-495880b4045f12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65857-425KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) (TILMANOCEPT) KIT [CARDINAL HEALTH 414, LLC]6Current NDC, Legacy NDC, 2 package rows20230928_72f31b09-4d7b-475c-b37a-9daf2ad80240.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65857-425-05658570425051 KIT in 1 CARTON (65857-425-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01) 1 kit2017-09-200000-00-00NoNoCurrent