ezetimibe

In shortageOrange BookUNIISPLATC C10AX09

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeC10AX09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6838277301
100 TABLET in 1 BOTTLE (68382-773-01)
ndc11
6838277305
500 TABLET in 1 BOTTLE (68382-773-05)
ndc11
6838277306
30 TABLET in 1 BOTTLE (68382-773-06)
ndc11
6838277310
1000 TABLET in 1 BOTTLE (68382-773-10)
ndc11
6838277316
90 TABLET in 1 BOTTLE (68382-773-16)
ndc11
6838277377
10 BLISTER PACK in 1 CARTON (68382-773-77) / 10 TABLET in 1 BLISTER PACK (68382-773-30)

Annotations

UNII (FDA Substance ID)

EOR26LQQ24

EZETIMIBE

RxCUI 341248

Orange Book

A204331

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": "68382-773_ebb60f24-14be-4be0-b5e2-31e695eae876",
  "productndc": "68382-773",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204331",
    "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": "ANDA204331",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ezetimibe",
  "start_marketing_date": "20170809",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C10AX09.

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