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United States · US · US:82009-024_98acb755-ad5c-414a-b9e9-6cd30c10a2e7
ezetimibe
In shortageOrange BookUNIISPLATC C10AX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQuallent Pharmaceuticals Health LLC
CountryUS (United States)
ATC codeC10AX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118200902405500 TABLET in 1 BOTTLE (82009-024-05)
Annotations
UNII (FDA Substance ID)
EOR26LQQ24
EZETIMIBE
RxCUI 341248
Orange Book
A204331
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ezetimibe Tablet
Raw payload (JSON)
{
"unii": {
"unii": "EOR26LQQ24",
"rxcui": "341248",
"inchikey": "OLNTVTPDXPETLC-XPWALMASSA-N",
"display_name": "EZETIMIBE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e257ed7f-5015-4f1d-93f4-5adf5797643d": {
"match": "brand_token",
"title": "EZETIMIBE TABLET [MAJOR PHARMACEUTICALS]",
"spl_version": "7",
"published_date": "2026-02-25"
}
},
"productid": "82009-024_98acb755-ad5c-414a-b9e9-6cd30c10a2e7",
"productndc": "82009-024",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204331",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jun 12, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EZETIMIBE",
"shortage_reason": "Ezetimibe Tablet",
"shortage_status": "current",
"proprietary_name": "ezetimibe",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204331",
"marketing_category": "ANDA",
"nonproprietary_name": "ezetimibe",
"start_marketing_date": "20220820",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C10AX09.
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