lazcluze

Generic: lazertinib

Labeler: janssen biotech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lazcluze
Generic Name lazertinib
Labeler janssen biotech, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lazertinib 80 mg/1

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-080
Product ID 57894-080_2a2d3969-bab8-4a8a-992d-439e62867974
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219008
Listing Expiration 2026-12-31
Marketing Start 2024-08-20

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
kinase inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] breast cancer resistance protein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894080
Hyphenated Format 57894-080

Supplemental Identifiers

RxCUI
2691156 2691162 2691164 2691166
UNII
4A2Y23XK11
NUI
N0000175605 N0000175082 N0000182141 N0000190113

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lazcluze (source: ndc)
Generic Name lazertinib (source: ndc)
Application Number NDA219008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (57894-080-60) / 60 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (57894-080-90) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

57894-080-60 1 BOTTLE in 1 CARTON (57894-080-60) / 60 TABLET, FILM COATED in 1 BOTTLE 57894-080-90 1 BOTTLE in 1 CARTON (57894-080-90) / 90 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

lazertinib (80 mg/1)

Linked Drug Pages (1)

LAZCLUZE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a2d3969-bab8-4a8a-992d-439e62867974", "openfda": {"nui": ["N0000175605", "N0000175082", "N0000182141", "N0000190113"], "unii": ["4A2Y23XK11"], "rxcui": ["2691156", "2691162", "2691164", "2691166"], "spl_set_id": ["c417f9ee-2027-4ed5-92ad-3c19266de16c"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Kinase Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (57894-080-60)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "57894-080-60", "marketing_start_date": "20240820"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (57894-080-90)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "57894-080-90", "marketing_start_date": "20240820"}], "brand_name": "LAZCLUZE", "product_id": "57894-080_2a2d3969-bab8-4a8a-992d-439e62867974", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]"], "product_ndc": "57894-080", "generic_name": "lazertinib", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LAZCLUZE", "active_ingredients": [{"name": "LAZERTINIB", "strength": "80 mg/1"}], "application_number": "NDA219008", "marketing_category": "NDA", "marketing_start_date": "20240820", "listing_expiration_date": "20261231"}