🇺🇸
United States · US · US:16714-101_ff9c9bd0-e2a2-4e38-aa8b-16d215d36450
Gemfibrozil
In shortageOrange BookUNIISPLATC C10AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthstar RxLLC
CountryUS (United States)
ATC codeC10AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11167141010260 TABLET in 1 BOTTLE (16714-101-02)
- ndc111671410105500 TABLET in 1 BOTTLE (16714-101-05)
Annotations
UNII (FDA Substance ID)
Q8X02027X3
GEMFIBROZIL
RxCUI 4719
Orange Book
A079072
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": "16714-101_ff9c9bd0-e2a2-4e38-aa8b-16d215d36450",
"productndc": "16714-101",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "079072",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Sep 13, 2010"
}
],
"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": "ANDA079072",
"marketing_category": "ANDA",
"nonproprietary_name": "gemfibrozil",
"start_marketing_date": "20101220",
"active_numerator_strength": "600"
}Related drugs
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