🇺🇸
United States · US · US:70771-1431_2f3cb828-6ff1-428d-99c7-edb835d25d10
Gemfibrozil
In shortageOrange BookUNIISPLATC C10AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeC10AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc1170771143101000 TABLET in 1 BOTTLE (70771-1431-0)
- ndc117077114311100 TABLET in 1 BOTTLE (70771-1431-1)
- ndc11707711431330 TABLET in 1 BOTTLE (70771-1431-3)
- ndc11707711431410 BLISTER PACK in 1 CARTON (70771-1431-4) / 10 TABLET in 1 BLISTER PACK
- ndc117077114315500 TABLET in 1 BOTTLE (70771-1431-5)
- ndc11707711431660 TABLET in 1 BOTTLE (70771-1431-6)
- ndc11707711431990 TABLET in 1 BOTTLE (70771-1431-9)
Annotations
UNII (FDA Substance ID)
Q8X02027X3
GEMFIBROZIL
RxCUI 4719
Orange Book
A204189
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": "70771-1431_2f3cb828-6ff1-428d-99c7-edb835d25d10",
"productndc": "70771-1431",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204189",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "Aug 28, 2018"
}
],
"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": "ANDA204189",
"marketing_category": "ANDA",
"nonproprietary_name": "Gemfibrozil",
"start_marketing_date": "20200221",
"active_numerator_strength": "600"
}Related drugs
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