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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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		2026-08-03
excluded package	package	50242-120	50242-120-01	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

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

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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	2026-06-01

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