🇺🇸
United States · US · US:69097-821_2d16c495-7862-4ffc-a9ee-a1c816af5ae5
Gemfibrozil
In shortageOrange BookUNIISPLATC C10AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeC10AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11690978210360 TABLET in 1 BOTTLE (69097-821-03)
- ndc116909782107100 TABLET in 1 BOTTLE (69097-821-07)
- ndc116909782112500 TABLET in 1 BOTTLE (69097-821-12)
Annotations
UNII (FDA Substance ID)
Q8X02027X3
GEMFIBROZIL
RxCUI 4719
Orange Book
A077836
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": "69097-821_2d16c495-7862-4ffc-a9ee-a1c816af5ae5",
"productndc": "69097-821",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077836",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Jul 27, 2006"
}
],
"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": "ANDA077836",
"marketing_category": "ANDA",
"nonproprietary_name": "Gemfibrozil",
"start_marketing_date": "20161013",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code C10AB04.
- 🇺🇸GemfibrozilBryant Ranch Prepack
- 🇺🇸GemfibrozilViona Pharmaceuticals Inc
- 🇺🇸GemfibrozilA-S Medication Solutions
- 🇺🇸GemfibrozilExelan Pharmaceuticals, Inc.
- 🇺🇸GemfibrozilNorthStar Rx LLC
- 🇺🇸GemfibrozilAphena Pharma Solutions - Tennessee, LLC
- 🇺🇸GemfibrozilPD-Rx Pharmaceuticals, Inc.
- 🇺🇸GemfibrozilProficient Rx LP
Access this data programmatically
Query Gemfibrozil and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.