Home NDC 50242-120-01 TNKase
Product NDC 50242-120
Requested package NDC 50242-120-01
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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.
DailyMed Product Concepts# 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 Socrata Ingredients# 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.
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 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