🇺🇸
United States · US · US:68382-553_9c4294b2-eee2-42d7-b260-6fc2e7e28833
Gemfibrozil
In shortageOrange BookUNIISPLATC C10AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeC10AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc116838255301100 TABLET in 1 BOTTLE (68382-553-01)
- ndc116838255305500 TABLET in 1 BOTTLE (68382-553-05)
- ndc11683825530630 TABLET in 1 BOTTLE (68382-553-06)
- ndc1168382553101000 TABLET in 1 BOTTLE (68382-553-10)
- ndc11683825531460 TABLET in 1 BOTTLE (68382-553-14)
- ndc11683825531690 TABLET in 1 BOTTLE (68382-553-16)
- ndc11683825533010 BLISTER PACK in 1 CARTON (68382-553-30) / 10 TABLET in 1 BLISTER PACK
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": "68382-553_9c4294b2-eee2-42d7-b260-6fc2e7e28833",
"productndc": "68382-553",
"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": "20190115",
"active_numerator_strength": "600"
}Related drugs
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