iqirvo

Generic: elafibranor

Labeler: ipsen biopharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name iqirvo
Generic Name elafibranor
Labeler ipsen biopharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

elafibranor 80 mg/1

Manufacturer
Ipsen Biopharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 15054-0080
Product ID 15054-0080_614b2fb1-3b17-49e1-a63d-869acaafa72e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218860
Listing Expiration 2026-12-31
Marketing Start 2024-06-10

Pharmacologic Class

Established (EPC)
peroxisome proliferator-activated receptor agonist [epc]
Mechanism of Action
peroxisome proliferator-activated receptor agonists [moa] cytochrome p450 3a4 inducers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 150540080
Hyphenated Format 15054-0080

Supplemental Identifiers

RxCUI
2684946 2684952
UNII
2J3H5C81A5
NUI
N0000194128 N0000194129 N0000185506

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 iqirvo (source: ndc)
Generic Name elafibranor (source: ndc)
Application Number NDA218860 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

15054-0080-1 1 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

elafibranor (80 mg/1)

Linked Drug Pages (1)

IQIRVO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "614b2fb1-3b17-49e1-a63d-869acaafa72e", "openfda": {"nui": ["N0000194128", "N0000194129", "N0000185506"], "unii": ["2J3H5C81A5"], "rxcui": ["2684946", "2684952"], "spl_set_id": ["d78aa14f-6ec1-4b1d-a4ae-e48658137a25"], "pharm_class_epc": ["Peroxisome Proliferator-activated Receptor Agonist [EPC]"], "pharm_class_moa": ["Peroxisome Proliferator-activated Receptor Agonists [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "manufacturer_name": ["Ipsen Biopharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (15054-0080-1)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "15054-0080-1", "marketing_start_date": "20240610"}], "brand_name": "IQIRVO", "product_id": "15054-0080_614b2fb1-3b17-49e1-a63d-869acaafa72e", "dosage_form": "TABLET, FILM COATED", "product_ndc": "15054-0080", "generic_name": "elafibranor", "labeler_name": "Ipsen Biopharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IQIRVO", "active_ingredients": [{"name": "ELAFIBRANOR", "strength": "80 mg/1"}], "application_number": "NDA218860", "marketing_category": "NDA", "marketing_start_date": "20240610", "listing_expiration_date": "20261231"}