lorbrena

Generic: lorlatinib

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorbrena
Generic Name lorlatinib
Labeler u.s. pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lorlatinib 25 mg/1

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-927
Product ID 63539-927_810ce789-bff1-42b9-aef7-1f92f0dde727
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210868
Listing Expiration 2027-12-31
Marketing Start 2023-01-03

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
kinase inhibitors [moa] cytochrome p450 3a inducers [moa] p-glycoprotein inducers [moa] cytochrome p450 2b6 inducers [moa] organic cation transporter 1 inhibitors [moa] organic anion transporter 3 inhibitors [moa] multidrug and toxin extrusion transporter 1 inhibitors [moa] breast cancer resistance protein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539927
Hyphenated Format 63539-927

Supplemental Identifiers

RxCUI
2103169 2103175
UNII
OSP71S83EU
NUI
N0000175605 N0000175082 N0000190118 N0000191264 N0000187064 N0000191265 N0000190111 N0000191423 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 lorbrena (source: ndc)
Generic Name lorlatinib (source: ndc)
Application Number NDA210868 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63539-927-01)
source: ndc

Packages (1)

63539-927-01 30 TABLET, FILM COATED in 1 BOTTLE (63539-927-01)

Ingredients (1)

lorlatinib (25 mg/1)

Linked Drug Pages (1)

Lorbrena ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "810ce789-bff1-42b9-aef7-1f92f0dde727", "openfda": {"nui": ["N0000175605", "N0000175082", "N0000190118", "N0000191264", "N0000187064", "N0000191265", "N0000190111", "N0000191423", "N0000190113"], "unii": ["OSP71S83EU"], "rxcui": ["2103169", "2103175"], "spl_set_id": ["004f93d7-a1cd-4b67-9207-31cdcb5c5976"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Kinase Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]", "P-Glycoprotein Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Organic Cation Transporter 1 Inhibitors [MoA]", "Organic Anion Transporter 3 Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63539-927-01)", "package_ndc": "63539-927-01", "marketing_start_date": "20230103"}], "brand_name": "Lorbrena", "product_id": "63539-927_810ce789-bff1-42b9-aef7-1f92f0dde727", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Organic Anion Transporter 3 Inhibitors [MoA]", "Organic Cation Transporter 1 Inhibitors [MoA]", "P-Glycoprotein Inducers [MoA]"], "product_ndc": "63539-927", "generic_name": "lorlatinib", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorbrena", "active_ingredients": [{"name": "LORLATINIB", "strength": "25 mg/1"}], "application_number": "NDA210868", "marketing_category": "NDA", "marketing_start_date": "20230103", "listing_expiration_date": "20271231"}