FDA.reportPublic FDA data

LAZCLUZE

Product NDC
57894-080
11-digit product format
578940080
Labeler code
57894
Product ID
57894-080_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
80 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

Additional Listing Data#

Finished product
Yes
Brand name base
LAZCLUZE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAZERTINIB80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A2Y23XK11
Rxcui2691156, 2691162, 2691164, 2691166

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f69de2bd-a386-4909-a9f0-76c28849dee3Product name120240829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57894-080-60LAZCLUZE60 in 1 BOTTLETABLET, FILM COATED606
57894-080-60LAZCLUZE1 in 1 CARTONTABLET, FILM COATED16
57894-080-90LAZCLUZE90 in 1 BOTTLETABLET, FILM COATED906
57894-080-90LAZCLUZE1 in 1 CARTONTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-080-60EA - Each57894-08067a2f235-98f3-4deb-8a78-3ae99c0f70a012024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-080LAZCLUZE (LAZERTINIB) TABLET, FILM COATED [JANSSEN BIOTECH, INC.]2Current NDC, 4 package rows20241116_c417f9ee-2027-4ed5-92ad-3c19266de16c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691166Lazcluze 240 MG Oral TabletPSNc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691162Lazcluze 80 MG Oral TabletPSNc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691164lazertinib 240 MG Oral TabletPSNc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691156lazertinib 80 MG Oral TabletPSNc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691166lazertinib 240 MG Oral Tablet [Lazcluze]SBDc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691162lazertinib 80 MG Oral Tablet [Lazcluze]SBDc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691164lazertinib 240 MG Oral TabletSCDc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691156lazertinib 80 MG Oral TabletSCDc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691166Lazcluze 240 MG (equivalent to lazertinib mesylate 281.58 MG) Oral TabletSYc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691166Lazcluze 240 MG Oral TabletSYc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691162Lazcluze 80 MG (equivalent to lazertinib mesylate 93.86 MG) Oral TabletSYc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691162Lazcluze 80 MG Oral TabletSYc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691164lazertinib 240 MG (equivalent to lazertinib mesylate 281.58 MG) Oral TabletSYc417f9ee-2027-4ed5-92ad-3c19266de16c6
2691156lazertinib 80 MG (equivalent to lazertinib mesylate 93.86 MG) Oral TabletSYc417f9ee-2027-4ed5-92ad-3c19266de16c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57894-080-60578940080601 BOTTLE in 1 CARTON (57894-080-60) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-08-20NoNoCurrent
57894-080-90578940080901 BOTTLE in 1 CARTON (57894-080-90) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-08-20NoNoCurrent