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United States · US · US:69238-1154_edb9906a-4007-40ff-a3dc-3083e50545ae

Ezetimibe

In shortageOrange BookUNIISPLATC C10AX09

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

Identification

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

Packs · 4

  • ndc11
    6923811541
    1000 TABLET in 1 BOTTLE (69238-1154-1)
  • ndc11
    6923811543
    30 TABLET in 1 BOTTLE (69238-1154-3)
  • ndc11
    6923811545
    500 TABLET in 1 BOTTLE (69238-1154-5)
  • ndc11
    6923811549
    90 TABLET in 1 BOTTLE (69238-1154-9)

Annotations

UNII (FDA Substance ID)
EOR26LQQ24
EZETIMIBE
RxCUI 341248
Orange Book
A208803
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": "69238-1154_edb9906a-4007-40ff-a3dc-3083e50545ae",
  "productndc": "69238-1154",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208803",
    "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": "ANDA208803",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ezetimibe",
  "start_marketing_date": "20170612",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C10AX09.

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