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United States · US · US:76333-170_161b88d8-6679-e793-e063-6394a90a481b

Ezetimibe

In shortageOrange BookUNIISPLATC C10AX09

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

Identification

ManufacturerOrient Pharma Co., Ltd.
CountryUS (United States)
ATC codeC10AX09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7633317012
    1000 TABLET in 1 BOTTLE (76333-170-12)
  • ndc11
    7633317013
    500 TABLET in 1 BOTTLE (76333-170-13)
  • ndc11
    7633317014
    90 TABLET in 1 BOTTLE (76333-170-14)
  • ndc11
    7633317015
    30 TABLET in 1 BOTTLE (76333-170-15)

Annotations

UNII (FDA Substance ID)
EOR26LQQ24
EZETIMIBE
RxCUI 341248
Orange Book
A215693
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": "76333-170_161b88d8-6679-e793-e063-6394a90a481b",
  "productndc": "76333-170",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215693",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Sep 13, 2022"
      }
    ],
    "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": "ANDA215693",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ezetimibe",
  "start_marketing_date": "20220630",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C10AX09.

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