Home NDC 57894-240 LAZCLUZE
Product NDC 57894-240
11-digit product format 578940240
Labeler code 57894
Product ID 57894-240_da4a9239-16d7-46cf-b089-e943e0080015
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lazertinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Janssen Biotech, Inc.
Application NDA219008
Marketing category NDA
Marketing start 2024-08-20
Substance LAZERTINIB
Active strength 240 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219008-001 LAZCLUZE LAZERTINIB MESYLATE EQ 80MG BASE TABLET / ORAL RLD 2024-08-19 N219008-002 LAZCLUZE LAZERTINIB MESYLATE EQ 240MG BASE TABLET / ORAL RLD, RS 2024-08-19
Orange Book patents# Current patent rows page 1 of 1 · 16 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219008-001 9593098 2035-10-13 U-3985 Drug substance, Drug product 2024-09-17 N219008-001 11453656 2038-04-18 Drug substance, Drug product 2024-09-17 N219008-001 11981659 2038-04-18 U-3985 2024-09-17 N219008-001 12318390 2038-04-18 Drug product 2025-10-17 N219008-001 12599606 2040-05-14 U-4512 2026-05-22 N219008-001 11879013 2040-05-21 U-3985 2024-09-17 N219008-001 12138351 2041-04-13 Drug product 2025-02-13 N219008-001 11850248 2041-08-01 U-3985 2024-09-17 N219008-002 9593098 2035-10-13 U-3985 Drug substance, Drug product 2024-09-17 N219008-002 11453656 2038-04-18 Drug substance, Drug product 2024-09-17 N219008-002 11981659 2038-04-18 U-3985 2024-09-17 N219008-002 12318390 2038-04-18 Drug product 2025-10-17 N219008-002 12599606 2040-05-14 U-4511 2026-05-12 N219008-002 11879013 2040-05-21 U-3985 2024-09-17 N219008-002 12138351 2041-04-13 Drug product 2025-02-13 N219008-002 11850248 2041-08-01 U-3985 2024-09-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219008-001 NCE 2029-08-19 N219008-002 NCE 2029-08-19
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219008-001 LAZCLUZE EQ 80MG BASE TABLET / ORAL RLD 2024-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-002 LAZCLUZE EQ 240MG BASE TABLET / ORAL RLD, RS 2024-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-001 LAZCLUZE EQ 80MG BASE TABLET / ORAL RLD 2024-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-002 LAZCLUZE EQ 240MG BASE TABLET / ORAL RLD, RS 2024-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219008-001 LAZCLUZE EQ 80MG BASE TABLET / ORAL RLD 2024-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219008-002 LAZCLUZE EQ 240MG BASE TABLET / ORAL RLD, RS 2024-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219008-001 LAZCLUZE EQ 80MG BASE TABLET / ORAL RLD 2024-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219008-002 LAZCLUZE EQ 240MG BASE TABLET / ORAL RLD, RS 2024-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219008-001 LAZCLUZE EQ 80MG BASE TABLET / ORAL RLD 2024-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219008-002 LAZCLUZE EQ 240MG BASE TABLET / ORAL RLD, RS 2024-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219008-001 LAZCLUZE EQ 80MG BASE TABLET / ORAL RLD 2024-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219008-002 LAZCLUZE EQ 240MG BASE TABLET / ORAL RLD, RS 2024-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219008-001 LAZCLUZE EQ 80MG BASE TABLET / ORAL RLD 2024-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219008-002 LAZCLUZE EQ 240MG BASE TABLET / ORAL RLD, RS 2024-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N219008-001 LAZCLUZE EQ 80MG BASE TABLET / ORAL RLD 2024-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N219008-002 LAZCLUZE EQ 240MG BASE TABLET / ORAL RLD, RS 2024-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N219008-001 LAZCLUZE EQ 80MG BASE TABLET / ORAL RLD 2024-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N219008-002 LAZCLUZE EQ 240MG BASE TABLET / ORAL RLD, RS 2024-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N219008-001 LAZCLUZE EQ 80MG BASE TABLET / ORAL RLD 2024-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N219008-002 LAZCLUZE EQ 240MG BASE TABLET / ORAL RLD, RS 2024-08-19 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219008-001 LAZCLUZE EQ 80MG BASE TABLET / ORAL RLD 2024-08-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219008-002 LAZCLUZE EQ 240MG BASE TABLET / ORAL RLD, RS 2024-08-19 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 118 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219008-001 9593098 2035-10-13 U-3985 Drug substance, Drug product 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-001 11453656 2038-04-18 Drug substance, Drug product 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-001 11981659 2038-04-18 U-3985 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-001 12318390 2038-04-18 Drug product 2025-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-001 11879013 2040-05-21 U-3985 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-001 12138351 2041-04-13 Drug product 2025-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-001 11850248 2041-08-01 U-3985 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-002 9593098 2035-10-13 U-3985 Drug substance, Drug product 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-002 11453656 2038-04-18 Drug substance, Drug product 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-002 11981659 2038-04-18 U-3985 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-002 12318390 2038-04-18 Drug product 2025-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-002 11879013 2040-05-21 U-3985 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-002 12138351 2041-04-13 Drug product 2025-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219008-002 11850248 2041-08-01 U-3985 2024-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-001 9593098 2035-10-13 U-3985 Drug substance, Drug product 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-001 11453656 2038-04-18 Drug substance, Drug product 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-001 11981659 2038-04-18 U-3985 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-001 12318390 2038-04-18 Drug product 2025-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-001 11879013 2040-05-21 U-3985 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-001 12138351 2041-04-13 Drug product 2025-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-001 11850248 2041-08-01 U-3985 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-002 9593098 2035-10-13 U-3985 Drug substance, Drug product 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-002 11453656 2038-04-18 Drug substance, Drug product 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-002 11981659 2038-04-18 U-3985 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-002 12318390 2038-04-18 Drug product 2025-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-002 11879013 2040-05-21 U-3985 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-002 12138351 2041-04-13 Drug product 2025-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219008-002 11850248 2041-08-01 U-3985 2024-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219008-001 9593098 2035-10-13 U-3985 Drug substance, Drug product 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219008-001 11453656 2038-04-18 Drug substance, Drug product 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219008-001 11981659 2038-04-18 U-3985 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219008-001 11879013 2040-05-21 U-3985 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219008-001 12138351 2041-04-13 Drug product 2025-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219008-001 11850248 2041-08-01 U-3985 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219008-002 9593098 2035-10-13 U-3985 Drug substance, Drug product 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219008-002 11453656 2038-04-18 Drug substance, Drug product 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219008-002 11981659 2038-04-18 U-3985 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219008-002 11879013 2040-05-21 U-3985 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219008-002 12138351 2041-04-13 Drug product 2025-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219008-002 11850248 2041-08-01 U-3985 2024-09-17 6a471c1ec25d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base LAZCLUZE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAZERTINIB 240 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4A2Y23XK11 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2691156 Internal RxNorm lookup 2691162 Internal RxNorm lookup 2691164 Internal RxNorm lookup 2691166 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 57894-240-30 LAZCLUZE 30 in 1 BOTTLE TABLET, FILM COATED 30 6 57894-240-30 LAZCLUZE 1 in 1 CARTON TABLET, FILM COATED 1 6 57894-240-99 LAZCLUZE 1 in 1 CARTON TABLET, FILM COATED 1 6 57894-240-99 LAZCLUZE 14 in 1 DOSE PACK TABLET, FILM COATED 14 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57894-240 LAZCLUZE (LAZERTINIB) TABLET, FILM COATED [JANSSEN BIOTECH, INC.] 2 Current NDC, 4 package rows 20241116_c417f9ee-2027-4ed5-92ad-3c19266de16c.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 57894-240-30 57894024030 1 BOTTLE in 1 CARTON (57894-240-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-08-20 No No Current 57894-240-99 57894024099 1 DOSE PACK in 1 CARTON (57894-240-99) / 14 TABLET, FILM COATED in 1 DOSE PACK 1 dose pack 2024-08-20 Yes No Current