ezetimibe and simvastatin

Orange BookUNIISPLATC C10AX

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

Identification

ManufacturerNORTHSTAR RX LLC

CountryUS (United States)

ATC codeC10AX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1671478101
30 TABLET in 1 BOTTLE (16714-781-01)
ndc11
1671478102
90 TABLET in 1 BOTTLE (16714-781-02)

Annotations

UNII (FDA Substance ID)

EOR26LQQ24

EZETIMIBE

RxCUI 341248

Orange Book

A208699

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": "16714-781_0d1ac067-fb51-46db-98da-5efd6a65e9e1",
  "productndc": "16714-781",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208699",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;10MG",
        "product_no": "001",
        "approval_date": "Jun 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;20MG",
        "product_no": "002",
        "approval_date": "Jun 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;40MG",
        "product_no": "003",
        "approval_date": "Jun 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;80MG",
        "product_no": "004",
        "approval_date": "Jun 27, 2019"
      }
    ],
    "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": "ANDA208699",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ezetimibe and simvastatin",
  "start_marketing_date": "20190819",
  "active_numerator_strength": "10; 80"
}

Related drugs

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