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United States · US · US:67877-490_878751ea-5bea-42ef-8f56-2b15a683c7ae

Ezetimibe

In shortageOrange BookUNIISPLATC C10AX09

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

Identification

ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeC10AX09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6787749001
    100 TABLET in 1 BOTTLE (67877-490-01)
  • ndc11
    6787749005
    500 TABLET in 1 BOTTLE (67877-490-05)
  • ndc11
    6787749030
    30 TABLET in 1 BOTTLE (67877-490-30)
  • ndc11
    6787749055
    5000 TABLET in 1 BOTTLE (67877-490-55)
  • ndc11
    6787749090
    90 TABLET in 1 BOTTLE (67877-490-90)

Annotations

UNII (FDA Substance ID)
EOR26LQQ24
EZETIMIBE
RxCUI 341248
Orange Book
A209234
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": "67877-490_878751ea-5bea-42ef-8f56-2b15a683c7ae",
  "productndc": "67877-490",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209234",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Dec 21, 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": "ANDA209234",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ezetimibe",
  "start_marketing_date": "20171223",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C10AX09.

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