Ezetimibe and Simvastatin

Orange BookUNIISPLATC C10AX

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

Identification

ManufacturerGolden State Medical Supply, Inc.

CountryUS (United States)

ATC codeC10AX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5140719230
30 TABLET in 1 BOTTLE (51407-192-30)

Annotations

UNII (FDA Substance ID)

EOR26LQQ24

EZETIMIBE

RxCUI 341248

Orange Book

A200909

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": "51407-192_446023ff-25b4-2c12-e063-6294a90ad27e",
  "productndc": "51407-192",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "200909",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;10MG",
        "product_no": "001",
        "approval_date": "Apr 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;20MG",
        "product_no": "002",
        "approval_date": "Apr 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;40MG",
        "product_no": "003",
        "approval_date": "Apr 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;80MG",
        "product_no": "004",
        "approval_date": "Apr 26, 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": "ANDA200909",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ezetimibe and Simvastatin",
  "start_marketing_date": "20170426",
  "active_numerator_strength": "10; 40"
}

Related drugs

Other records sharing ATC code C10AX.

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