lorbrena (0069-0231) | FunFoxMeds NDC

Drug Facts

Product Profile

Brand Name lorbrena

Generic Name lorlatinib

Labeler pfizer laboratories div pfizer inc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

lorlatinib 100 mg/1

Manufacturer

Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0231

Product ID 0069-0231_fa9433bd-5ed2-47c3-84cb-f751c1345f81

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA210868

Listing Expiration 2027-12-31

Marketing Start 2018-11-19

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 00690231

Hyphenated Format 0069-0231

Supplemental Identifiers

RxCUI

2103169 2103175 2103177 2103179

UPC

0300690231013 0300690227016

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

100 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (0069-0231-01)

source: ndc

Packages (1)

0069-0231-01 30 TABLET, FILM COATED in 1 BOTTLE (0069-0231-01)

Ingredients (1)

lorlatinib (100 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": "fa9433bd-5ed2-47c3-84cb-f751c1345f81", "openfda": {"nui": ["N0000175605", "N0000175082", "N0000190118", "N0000191264", "N0000187064", "N0000191265", "N0000190111", "N0000191423", "N0000190113"], "upc": ["0300690231013", "0300690227016"], "unii": ["OSP71S83EU"], "rxcui": ["2103169", "2103175", "2103177", "2103179"], "spl_set_id": ["2b34d62d-e02a-4af3-bc0d-1571dd4ee76d"], "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": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0069-0231-01)", "package_ndc": "0069-0231-01", "marketing_start_date": "20181119"}], "brand_name": "Lorbrena", "product_id": "0069-0231_fa9433bd-5ed2-47c3-84cb-f751c1345f81", "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": "0069-0231", "generic_name": "lorlatinib", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorbrena", "active_ingredients": [{"name": "LORLATINIB", "strength": "100 mg/1"}], "application_number": "NDA210868", "marketing_category": "NDA", "marketing_start_date": "20181119", "listing_expiration_date": "20271231"}