🇺🇸
United States · US · US:68788-7964_f8ae4088-7e33-4a6c-943c-20dee3256974
GEMFIBROZIL
In shortageOrange BookUNIISPLATC C10AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC10AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11687887964330 TABLET in 1 BOTTLE (68788-7964-3)
- ndc11687887964660 TABLET in 1 BOTTLE (68788-7964-6)
- ndc11687887964990 TABLET in 1 BOTTLE (68788-7964-9)
Annotations
UNII (FDA Substance ID)
Q8X02027X3
GEMFIBROZIL
RxCUI 4719
Orange Book
A214603
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": "68788-7964_f8ae4088-7e33-4a6c-943c-20dee3256974",
"productndc": "68788-7964",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214603",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Jan 13, 2021"
}
],
"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": "ANDA214603",
"marketing_category": "ANDA",
"nonproprietary_name": "Gemfibrozil",
"start_marketing_date": "20210720",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code C10AB04.
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