Gemfibrozil

In shortageOrange BookUNIISPLATC C10AB04

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeC10AB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7161020060
90 TABLET in 1 BOTTLE (71610-200-60)

Annotations

UNII (FDA Substance ID)

Q8X02027X3

GEMFIBROZIL

RxCUI 4719

Orange Book

A077836

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": "71610-200_540018a9-7f17-4295-9d61-7ce5adce89f7",
  "productndc": "71610-200",
  "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": "20161013",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code C10AB04.

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