🇺🇸
United States · US · US:72578-066_81e93b62-553c-4553-9f0e-44f06293ae7d
Gemfibrozil
In shortageOrange BookUNIISPLATC C10AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeC10AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc117257806601100 TABLET in 1 BOTTLE (72578-066-01)
- ndc117257806605500 TABLET in 1 BOTTLE (72578-066-05)
- ndc11725780660630 TABLET in 1 BOTTLE (72578-066-06)
- ndc1172578066101000 TABLET in 1 BOTTLE (72578-066-10)
- ndc11725780661460 TABLET in 1 BOTTLE (72578-066-14)
- ndc11725780661690 TABLET in 1 BOTTLE (72578-066-16)
- ndc11725780667710 BLISTER PACK in 1 CARTON (72578-066-77) / 10 TABLET in 1 BLISTER PACK (72578-066-30)
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": "72578-066_81e93b62-553c-4553-9f0e-44f06293ae7d",
"productndc": "72578-066",
"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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