FDA.reportPublic FDA data

TNKase

Product NDC
50242-120
11-digit product format
502420120
Labeler code
50242
Product ID
50242-120_f5fbdeb3-d456-45dc-8c37-4e15ca1c66ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tenecteplase
Dosage form
KIT
Labeler
Genentech, Inc.
Application
BLA103909
Marketing category
BLA
Marketing start
2018-11-07
Marketing end
2027-01-31
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TNKase

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui284422, 313212

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-037-06TNKase10 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,10 mL50 mg in 10mL16
50242-037-06TNKase1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,50 mg in 10mL16
50242-120-47TNKase1 in 1 CARTONKIT116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-120-01EA - Each50242-12047f01718-adf7-4ef3-a2ca-fb877f3edc5f12012-07-24
50242-120-47EA - Each50242-12074247d3f-44b9-4e2e-85db-2c280306829612019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-120TNKASE (TENECTEPLASE) KIT [GENENTECH, INC.]14Current NDC, Legacy NDC, 3 package rows20250412_739a3c53-caf6-40d6-a6af-84ce733a948b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313212tenecteplase 50 MG InjectionPSN739a3c53-caf6-40d6-a6af-84ce733a948b16
284422TNKase 50 MG InjectionPSN739a3c53-caf6-40d6-a6af-84ce733a948b16
284422tenecteplase 50 MG Injection [Tnkase]SBD739a3c53-caf6-40d6-a6af-84ce733a948b16
313212tenecteplase 50 MG InjectionSCD739a3c53-caf6-40d6-a6af-84ce733a948b16
284422Tnkase 50 MG InjectionSY739a3c53-caf6-40d6-a6af-84ce733a948b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50242-037-065024200370610 mL in 1 VIAL, SINGLE-USE10 mlHistorical
50242-120-01502420120011 KIT in 1 CARTON (50242-120-01) * 10 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 PACKET * 50 mg in 1 VIAL, SINGLE-USE1 kit2000-06-020000-00-00NoNoCurrent
50242-120-47502420120471 KIT in 1 CARTON (50242-120-47) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06) / 10 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09) / 10 mL in 1 VIAL, SINGLE-USE1 kit2018-11-072027-01-31NoNoCurrent