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United States · US · US:50228-379_1ab4be5f-4926-88ad-e063-6294a90a0c81

Ezetimibe

In shortageOrange BookUNIISPLATC C10AX09

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

Identification

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

Packs · 4

  • ndc11
    5022837905
    500 TABLET in 1 BOTTLE (50228-379-05)
  • ndc11
    5022837910
    1000 TABLET in 1 BOTTLE (50228-379-10)
  • ndc11
    5022837930
    30 TABLET in 1 BOTTLE (50228-379-30)
  • ndc11
    5022837990
    90 TABLET in 1 BOTTLE (50228-379-90)

Annotations

UNII (FDA Substance ID)
EOR26LQQ24
EZETIMIBE
RxCUI 341248
Orange Book
A210673
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": "50228-379_1ab4be5f-4926-88ad-e063-6294a90a0c81",
  "productndc": "50228-379",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210673",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 23, 2020"
      }
    ],
    "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": "ANDA210673",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ezetimibe",
  "start_marketing_date": "20201023",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C10AX09.

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