VYTORIN

Orange BookUNIISPLATC C10AX

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

Identification

ManufacturerOrganon LLC

CountryUS (United States)

ATC codeC10AX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7820617601
30 TABLET in 1 BOTTLE (78206-176-01)
ndc11
7820617602
90 TABLET in 1 BOTTLE (78206-176-02)

Annotations

UNII (FDA Substance ID)

EOR26LQQ24

EZETIMIBE

RxCUI 341248

Orange Book

N021687

ABABABAB

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": {
    "89b860d2-de83-468e-b7e8-76aeec2edca2": {
      "match": "brand_token",
      "title": "VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [ORGANON LLC]",
      "spl_version": "9",
      "published_date": "2026-01-23"
    }
  },
  "productid": "78206-176_9e668c78-ea5d-4099-ba16-b77aebbcb68a",
  "productndc": "78206-176",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021687",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;10MG",
        "product_no": "001",
        "approval_date": "Jul 23, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;20MG",
        "product_no": "002",
        "approval_date": "Jul 23, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;40MG",
        "product_no": "003",
        "approval_date": "Jul 23, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;80MG",
        "product_no": "004",
        "approval_date": "Jul 23, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EZETIMIBE; SIMVASTATIN",
  "proprietary_name": "VYTORIN",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021687",
  "marketing_category": "NDA",
  "nonproprietary_name": "ezetimibe and simvastatin",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "10; 40"
}

Related drugs

Other records sharing ATC code C10AX.

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