retevmo

Generic: selpercatinib

Labeler: eli lilly and company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name retevmo
Generic Name selpercatinib
Labeler eli lilly and company
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

selpercatinib 160 mg/1

Manufacturer
Eli Lilly and Company

Identifiers & Regulatory

Product NDC 0002-5562
Product ID 0002-5562_94e137ac-9f6b-4904-8999-3e55603a2407
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218160
Listing Expiration 2026-12-31
Marketing Start 2024-04-10

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
rearranged during transfection (ret) inhibitors [moa] cytochrome p450 2c8 inhibitors [moa] cytochrome p450 3a inhibitors [moa] p-glycoprotein inhibitors [moa] breast cancer resistance protein inhibitors [moa] multidrug and toxin extrusion transporter 1 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00025562
Hyphenated Format 0002-5562

Supplemental Identifiers

RxCUI
2370164 2370170 2370172 2370174 2679805 2679808 2679810 2679812 2679813 2679814 2679815 2679816
UNII
CEGM9YBNGD
NUI
N0000175605 N0000193947 N0000187062 N0000190114 N0000185503 N0000190113 N0000191423

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 retevmo (source: ndc)
Generic Name selpercatinib (source: ndc)
Application Number NDA218160 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 60 TABLET, COATED in 1 BOTTLE (0002-5562-60)
source: ndc

Packages (1)

0002-5562-60 60 TABLET, COATED in 1 BOTTLE (0002-5562-60)

Ingredients (1)

selpercatinib (160 mg/1)

Linked Drug Pages (1)

RETEVMO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "94e137ac-9f6b-4904-8999-3e55603a2407", "openfda": {"nui": ["N0000175605", "N0000193947", "N0000187062", "N0000190114", "N0000185503", "N0000190113", "N0000191423"], "unii": ["CEGM9YBNGD"], "rxcui": ["2370164", "2370170", "2370172", "2370174", "2679805", "2679808", "2679810", "2679812", "2679813", "2679814", "2679815", "2679816"], "spl_set_id": ["7fa848ba-a59c-4144-9f52-64d090f4d828"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Rearranged during Transfection (RET) Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]"], "manufacturer_name": ["Eli Lilly and Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (0002-5562-60)", "package_ndc": "0002-5562-60", "marketing_start_date": "20240410"}], "brand_name": "RETEVMO", "product_id": "0002-5562_94e137ac-9f6b-4904-8999-3e55603a2407", "dosage_form": "TABLET, COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Rearranged during Transfection (RET) Inhibitors [MoA]"], "product_ndc": "0002-5562", "generic_name": "selpercatinib", "labeler_name": "Eli Lilly and Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RETEVMO", "active_ingredients": [{"name": "SELPERCATINIB", "strength": "160 mg/1"}], "application_number": "NDA218160", "marketing_category": "NDA", "marketing_start_date": "20240410", "listing_expiration_date": "20261231"}