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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50242-120		D	Discontinued by firm		2026-09-14
excluded package	package	50242-120	50242-120-01	D	Discontinued by firm		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50242-120-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50242-120-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50242-120-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50242-120-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50242-120-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50242-120-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50242-120-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50242-120-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50242-120-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50242-120-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50242-120-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50242-120-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: TNKase

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
739a3c53-caf6-40d6-a6af-84ce733a948b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50242-037-06	TNKase	10 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	10 mL	50 mg in 10mL	16
50242-037-06	TNKase	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,		50 mg in 10mL	16
50242-120-47	TNKase	1 in 1 CARTON	KIT	1		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50242-120-01	EA - Each	50242-120	47f01718-adf7-4ef3-a2ca-fb877f3edc5f	1	2012-07-24
50242-120-47	EA - Each	50242-120	74247d3f-44b9-4e2e-85db-2c2803068296	1	2019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tenecteplase	ACTIVE INGREDIENT	WGD229O42W	TNKASE (TENECTEPLASE) KIT [GENENTECH, INC.]	1
tenecteplase	ACTIVE MOIETY	WGD229O42W	TNKASE (TENECTEPLASE) KIT [GENENTECH, INC.]	1
Arginine	INACTIVE INGREDIENT	94ZLA3W45F	TNKASE (TENECTEPLASE) KIT [GENENTECH, INC.]	1
Phosphoric Acid	INACTIVE INGREDIENT	E4GA8884NN	TNKASE (TENECTEPLASE) KIT [GENENTECH, INC.]	1
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	TNKASE (TENECTEPLASE) KIT [GENENTECH, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	TNKASE (TENECTEPLASE) KIT [GENENTECH, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50242-120	TNKASE (TENECTEPLASE) KIT [GENENTECH, INC.]	14	Current NDC, Legacy NDC, 3 package rows	20250412_739a3c53-caf6-40d6-a6af-84ce733a948b.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TNKase	TENECTEPLASE	Genentech, Inc.	e647640d-c395-4b4b-a0be-1162f9c21d84	2025-12-15	Warnings, Adverse reactions	Exact identifier application number: BLA103909
TNKase	TENECTEPLASE	Genentech, Inc.	739a3c53-caf6-40d6-a6af-84ce733a948b	2025-12-15	Warnings, Adverse reactions	Exact identifier application number: BLA103909 ndc (product): 50242-120

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103909	TNKase	tenecteplase	351(a)	Rx	2026-08-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WGD229O42W	TENECTEPLASE	191588-94-0	tenecteplase

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313212	tenecteplase 50 MG Injection	PSN	739a3c53-caf6-40d6-a6af-84ce733a948b	16
284422	TNKase 50 MG Injection	PSN	739a3c53-caf6-40d6-a6af-84ce733a948b	16
284422	tenecteplase 50 MG Injection [Tnkase]	SBD	739a3c53-caf6-40d6-a6af-84ce733a948b	16
313212	tenecteplase 50 MG Injection	SCD	739a3c53-caf6-40d6-a6af-84ce733a948b	16
284422	Tnkase 50 MG Injection	SY	739a3c53-caf6-40d6-a6af-84ce733a948b	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50242-037-06	50242003706	10 mL in 1 VIAL, SINGLE-USE	10 ml					Historical
50242-120-01	50242012001	1 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-USE	1 kit	2000-06-02	0000-00-00	No	No	Current
50242-120-47	50242012047	1 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-USE	1 kit	2018-11-07	2027-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TNKase	Genentech, Inc. \| Genentech, Inc. (Hillsboro) \| Genentech, Inc. (OCN)	2025-12-15	HUMAN PRESCRIPTION DRUG LABEL	16
TNKase	Genentech, Inc. \| Genentech, Inc. (Hillsboro) \| Roche Diagnostics GmbH Pharma Biotech \| Genentech, Inc. (OCN) \| Roche Singapore Technical Operations Pte. Ltd. \| Labor LS SE & Co. KG	2019-12-24	HUMAN PRESCRIPTION DRUG LABEL	9