🇺🇸
United States · US · US:82576-080_e56ac6db-56ac-4d3d-8f56-5497bab115df
REZDIFFRA
Orange BookUNIISPLATC A05BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMadrigal Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA05BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11825760803030 TABLET, COATED in 1 BOTTLE (82576-080-30)
- ndc11825760809090 TABLET, COATED in 1 BOTTLE (82576-080-90)
Annotations
UNII (FDA Substance ID)
RE0V0T1ES0
RESMETIROM
Orange Book
N217785
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "RE0V0T1ES0",
"rxcui": null,
"inchikey": "FDBYIYFVSAHJLY-UHFFFAOYSA-N",
"display_name": "RESMETIROM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e67ea09f-a840-439c-86c8-f98585f978b2": {
"match": "brand_token",
"title": "REZDIFFRA (RESMETIROM) TABLET, COATED REZDIFFRA (RESMETIROM) TABLET, COATED REZDIFFRA (RESMETIROM) TABLET, COATED [MADRIGAL PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2025-12-31"
}
},
"productid": "82576-080_e56ac6db-56ac-4d3d-8f56-5497bab115df",
"productndc": "82576-080",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "217785",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "60MG",
"product_no": "001",
"approval_date": "Mar 14, 2024"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "80MG",
"product_no": "002",
"approval_date": "Mar 14, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "003",
"approval_date": "Mar 14, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RESMETIROM",
"proprietary_name": "REZDIFFRA",
"active_ingred_unit": "mg/1",
"application_number": "NDA217785",
"marketing_category": "NDA",
"nonproprietary_name": "resmetirom",
"start_marketing_date": "20240314",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code A05BA.
- PLEsseliv forteAflofarm Farmacja Polska Sp. z o.o.
- PLEsseliv MaxAflofarm Farmacja Polska Sp. z o.o.
- PLEssentiale forteOpella Healthcare Poland Sp. z o.o.
- PLEssentiale MaxOpella Healthcare Poland Sp. z o.o.
- PLHepa-MerzInPharm Sp. z o.o.
- PLHepa-MerzDelfarma Sp. z o.o.
- PLHepa-MerzAga Kommerz spol. s r.o.
- PLHepa-MerzDelfarma Sp. z o.o.
Access this data programmatically
Query REZDIFFRA and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.