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United States · US · US:33342-373_ebe3fa4e-82c4-4a9a-9aec-f64019391f4e

Ezetimibe

In shortageOrange BookUNIISPLATC C10AX09

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeC10AX09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    3334237307
    30 TABLET in 1 BOTTLE (33342-373-07)
  • ndc11
    3334237310
    90 TABLET in 1 BOTTLE (33342-373-10)
  • ndc11
    3334237315
    500 TABLET in 1 BOTTLE (33342-373-15)

Annotations

UNII (FDA Substance ID)
EOR26LQQ24
EZETIMIBE
RxCUI 341248
Orange Book
A211159
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": "33342-373_ebe3fa4e-82c4-4a9a-9aec-f64019391f4e",
  "productndc": "33342-373",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211159",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Apr 29, 2024"
      }
    ],
    "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": "ANDA211159",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ezetimibe",
  "start_marketing_date": "20240429",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C10AX09.

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