🇺🇸
United States · US · US:62135-160_2589e155-f097-67fc-e063-6294a90a20b8
Gemfibrozil
In shortageOrange BookUNIISPLATC C10AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeC10AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116213516031300 TABLET, FILM COATED in 1 BOTTLE (62135-160-31)
- ndc11621351606060 TABLET, FILM COATED in 1 BOTTLE (62135-160-60)
Annotations
UNII (FDA Substance ID)
Q8X02027X3
GEMFIBROZIL
RxCUI 4719
Orange Book
A074270
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": "62135-160_2589e155-f097-67fc-e063-6294a90a20b8",
"productndc": "62135-160",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "074270",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Sep 27, 1993"
}
],
"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": "ANDA074270",
"marketing_category": "ANDA",
"nonproprietary_name": "Gemfibrozil",
"start_marketing_date": "19930927",
"active_numerator_strength": "600"
}Related drugs
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