🇺🇸
United States · US · US:71335-2025_65788163-66b9-44fb-a267-a313c4329020
Gemfibrozil
In shortageOrange BookUNIISPLATC C10AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC10AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11713352025160 TABLET, FILM COATED in 1 BOTTLE (71335-2025-1)
- ndc11713352025230 TABLET, FILM COATED in 1 BOTTLE (71335-2025-2)
- ndc117133520253100 TABLET, FILM COATED in 1 BOTTLE (71335-2025-3)
- ndc11713352025490 TABLET, FILM COATED in 1 BOTTLE (71335-2025-4)
- ndc117133520255180 TABLET, FILM COATED in 1 BOTTLE (71335-2025-5)
Annotations
UNII (FDA Substance ID)
Q8X02027X3
GEMFIBROZIL
RxCUI 4719
Orange Book
A202726
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": "71335-2025_65788163-66b9-44fb-a267-a313c4329020",
"productndc": "71335-2025",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202726",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Sep 16, 2015"
}
],
"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": "ANDA202726",
"marketing_category": "ANDA",
"nonproprietary_name": "Gemfibrozil",
"start_marketing_date": "20150916",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code C10AB04.
- 🇺🇸GemfibrozilViona Pharmaceuticals Inc
- 🇺🇸GemfibrozilProficient Rx LP
- 🇺🇸GemfibrozilA-S Medication Solutions
- 🇺🇸GemfibrozilExelan Pharmaceuticals, Inc.
- 🇺🇸GemfibrozilNorthStar Rx LLC
- 🇺🇸GemfibrozilAphena Pharma Solutions - Tennessee, LLC
- 🇺🇸GemfibrozilPD-Rx Pharmaceuticals, Inc.
- 🇺🇸GemfibrozilNuCare Pharmaceuticals,Inc.
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