Gemfibrozil

In shortageOrange BookUNIISPLATC C10AB04

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeC10AB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009072340
90 TABLET, FILM COATED in 1 BOTTLE (50090-7234-0)

Annotations

UNII (FDA Substance ID)

Q8X02027X3

GEMFIBROZIL

RxCUI 4719

Orange Book

A202726

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": "50090-7234_ce1cb74e-4218-4fdb-a84b-bd5918d2f120",
  "productndc": "50090-7234",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202726",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Sep 16, 2015"
      }
    ],
    "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": "ANDA202726",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gemfibrozil",
  "start_marketing_date": "20150916",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code C10AB04.

Access this data programmatically

Query Gemfibrozil and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs