FDA.reportPublic FDA data

TNKase

Product NDC
50242-014
11-digit product format
502420014
Labeler code
50242
Product ID
50242-014_d87d7f04-a851-4187-846d-527dd4bbab6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tenecteplase
Dosage form
KIT
Labeler
Genentech, Inc.
Application
BLA103909
Marketing category
BLA
Marketing start
2025-02-28
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TNKase
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
284422Internal RxNorm lookup
313212Internal RxNorm lookup
2711697Internal RxNorm lookup
2711699Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e647640d-c395-4b4b-a0be-1162f9c21d84Available on FDA.report

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
50242-009-01TNKase1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,25 mg in 5mL4
50242-009-01TNKase5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,5 mL25 mg in 5mL4
50242-014-03TNKase1 in 1 CARTONKIT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-014-03EA - Each50242-0141b1a5bdd-1071-41ac-b259-f03d6525c69f12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-014TNKASE (TENECTEPLASE) KIT [GENENTECH, INC.]3Current NDC, 3 package rows20250412_e647640d-c395-4b4b-a0be-1162f9c21d84.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TNKaseTENECTEPLASEGenentech, Inc.e647640d-c395-4b4b-a0be-1162f9c21d842025-12-15Warnings, Adverse reactionsExact identifier
application number: BLA103909
ndc (product): 50242-014
TNKaseTENECTEPLASEGenentech, Inc.739a3c53-caf6-40d6-a6af-84ce733a948b2025-12-15Warnings, Adverse reactionsExact identifier
application number: BLA103909

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103909TNKasetenecteplase351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2711697tenecteplase 25 MG InjectionPSNe647640d-c395-4b4b-a0be-1162f9c21d844
313212tenecteplase 50 MG InjectionPSNe647640d-c395-4b4b-a0be-1162f9c21d844
2711699TNKase 25 MG InjectionPSNe647640d-c395-4b4b-a0be-1162f9c21d844
284422TNKase 50 MG InjectionPSNe647640d-c395-4b4b-a0be-1162f9c21d844
2711699tenecteplase 25 MG Injection [Tnkase]SBDe647640d-c395-4b4b-a0be-1162f9c21d844
284422tenecteplase 50 MG Injection [Tnkase]SBDe647640d-c395-4b4b-a0be-1162f9c21d844
2711697tenecteplase 25 MG InjectionSCDe647640d-c395-4b4b-a0be-1162f9c21d844
313212tenecteplase 50 MG InjectionSCDe647640d-c395-4b4b-a0be-1162f9c21d844
2711699Tnkase 25 MG InjectionSYe647640d-c395-4b4b-a0be-1162f9c21d844
284422Tnkase 50 MG InjectionSYe647640d-c395-4b4b-a0be-1162f9c21d844

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50242-009-01502420009011 in 1 CARTONHistorical
50242-014-03502420014031 KIT in 1 CARTON (50242-014-03) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-009-01) / 5 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-907-01) / 5.2 mL in 1 VIAL, SINGLE-USE1 kit2025-02-28NoNoCurrent