Ezetimibe and Simvastatin

Orange BookUNIISPLATC C10AX

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeC10AX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6787750701
1000 TABLET in 1 BOTTLE (67877-507-01)
ndc11
6787750730
30 TABLET in 1 BOTTLE (67877-507-30)
ndc11
6787750738
10 BLISTER PACK in 1 CARTON (67877-507-38) / 10 TABLET in 1 BLISTER PACK (67877-507-33)
ndc11
6787750790
90 TABLET in 1 BOTTLE (67877-507-90)

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": "67877-507_ca1a42e2-f129-462a-8e87-a034da71862b",
  "productndc": "67877-507",
  "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; 10"
}

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