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United States · US · US:72065-003_ed08de98-fda5-455e-94b3-79ebf1c046cd
Recorlev
Orange BookUNIISPLATC H02CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXeris Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeH02CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11720650030150 TABLET in 1 BOTTLE (72065-003-01)
Annotations
UNII (FDA Substance ID)
2DJ8R0NT7K
LEVOKETOCONAZOLE
RxCUI 2588846
Orange Book
N214133
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2DJ8R0NT7K",
"rxcui": "2588846",
"inchikey": "XMAYWYJOQHXEEK-ZEQKJWHPSA-N",
"display_name": "LEVOKETOCONAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d4c5fead-bc4a-fb02-e053-2a95a90ae4fc": {
"match": "brand_token",
"title": "RECORLEV (LEVOKETOCONAZOLE) TABLET [XERIS PHARMACEUTICALS, INC.]",
"spl_version": "12",
"published_date": "2026-03-12"
}
},
"productid": "72065-003_ed08de98-fda5-455e-94b3-79ebf1c046cd",
"productndc": "72065-003",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214133",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "150MG",
"product_no": "001",
"approval_date": "Dec 30, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOKETOCONAZOLE",
"proprietary_name": "Recorlev",
"active_ingred_unit": "mg/1",
"application_number": "NDA214133",
"marketing_category": "NDA",
"nonproprietary_name": "Levoketoconazole",
"start_marketing_date": "20211230",
"active_numerator_strength": "150"
}Access this data programmatically
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