🇺🇸
United States · US · US:50090-5808_b54f187d-2cb7-4fb7-9fae-2fc9e812667a
GEMFIBROZIL
In shortageOrange BookUNIISPLATC C10AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeC10AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11500905808060 TABLET in 1 BOTTLE (50090-5808-0)
- ndc11500905808290 TABLET in 1 BOTTLE (50090-5808-2)
- ndc11500905808330 TABLET in 1 BOTTLE (50090-5808-3)
- ndc115009058084180 TABLET in 1 BOTTLE (50090-5808-4)
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": "50090-5808_b54f187d-2cb7-4fb7-9fae-2fc9e812667a",
"productndc": "50090-5808",
"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": "20210120",
"active_numerator_strength": "600"
}Related drugs
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