Ezetimibe and Simvastatin

Orange BookUNIISPLATC C10AX

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC codeC10AX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6923811563
30 TABLET in 1 BOTTLE (69238-1156-3)
ndc11
6923811569
90 TABLET in 1 BOTTLE (69238-1156-9)

Annotations

UNII (FDA Substance ID)

EOR26LQQ24

EZETIMIBE

RxCUI 341248

Orange Book

A208831

DailyMed SPL labels

1 version tracked

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": "69238-1156_331b2e88-9d76-4e41-bca7-bcff0e206614",
  "productndc": "69238-1156",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208831",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG;10MG",
        "product_no": "001",
        "approval_date": "Nov 21, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG;20MG",
        "product_no": "002",
        "approval_date": "Nov 21, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG;40MG",
        "product_no": "003",
        "approval_date": "Nov 21, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG;80MG",
        "product_no": "004",
        "approval_date": "Nov 21, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EZETIMIBE; SIMVASTATIN",
  "proprietary_name": "Ezetimibe and Simvastatin",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA208831",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ezetimibe and Simvastatin",
  "start_marketing_date": "20171121",
  "active_numerator_strength": "10; 20"
}

Related drugs

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