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United States · US · US:66267-436_1fa6f6ca-cf67-49fd-e063-6394a90a73f2

Gemfibrozil

In shortageOrange BookUNIISPLATC C10AB04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNuCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC10AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6626743630
    30 TABLET in 1 BOTTLE (66267-436-30)
  • ndc11
    6626743660
    60 TABLET in 1 BOTTLE (66267-436-60)
  • ndc11
    6626743692
    180 TABLET in 1 BOTTLE (66267-436-92)

Annotations

UNII (FDA Substance ID)
Q8X02027X3
GEMFIBROZIL
RxCUI 4719
Orange Book
A077836
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Gemfibrozil Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "Q8X02027X3",
    "rxcui": "4719",
    "inchikey": "HEMJJKBWTPKOJG-UHFFFAOYSA-N",
    "display_name": "GEMFIBROZIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2f5738ac-1c9c-4f3a-8c7d-6039d768831e": {
      "match": "brand_token",
      "title": "GEMFIBROZIL TABLET [PREFERRED PHARMACEUTICALS, INC.]",
      "spl_version": "6",
      "published_date": "2026-05-07"
    }
  },
  "productid": "66267-436_1fa6f6ca-cf67-49fd-e063-6394a90a73f2",
  "productndc": "66267-436",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077836",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Jul 27, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GEMFIBROZIL",
  "shortage_reason": "Gemfibrozil Tablet",
  "shortage_status": "current",
  "proprietary_name": "Gemfibrozil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077836",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gemfibrozil",
  "start_marketing_date": "20160708",
  "active_numerator_strength": "600"
}

Related drugs

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