Ezetimibe and Simvastatin

Orange BookUNIISPLATC C10AX

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeC10AX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009047720
90 TABLET in 1 BOTTLE (50090-4772-0)

Annotations

UNII (FDA Substance ID)

EOR26LQQ24

EZETIMIBE

RxCUI 341248

Orange Book

A209222

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": {
    "e257ed7f-5015-4f1d-93f4-5adf5797643d": {
      "match": "brand_token",
      "title": "EZETIMIBE TABLET [MAJOR PHARMACEUTICALS]",
      "spl_version": "7",
      "published_date": "2026-02-25"
    }
  },
  "productid": "50090-4772_c47669cc-ed22-4780-804f-d5859d01dff9",
  "productndc": "50090-4772",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209222",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;10MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;20MG",
        "product_no": "002",
        "approval_date": "Dec 22, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;40MG",
        "product_no": "003",
        "approval_date": "Dec 22, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;80MG",
        "product_no": "004",
        "approval_date": "Dec 22, 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": "ANDA209222",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ezetimibe and Simvastatin",
  "start_marketing_date": "20171224",
  "active_numerator_strength": "10; 40"
}

Related drugs

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