🇺🇸
United States · US · US:71209-008_b3071718-e27b-4690-88dd-fc58a4fcbf41
Gemfibrozil
In shortageOrange BookUNIISPLATC C10AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCadila Pharmaceuticals Limited
CountryUS (United States)
ATC codeC10AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11712090080360 TABLET in 1 BOTTLE (71209-008-03)
- ndc117120900808180 TABLET in 1 BOTTLE (71209-008-08)
- ndc117120900810500 TABLET in 1 BOTTLE (71209-008-10)
Annotations
UNII (FDA Substance ID)
Q8X02027X3
GEMFIBROZIL
RxCUI 4719
Orange Book
A203266
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": "71209-008_b3071718-e27b-4690-88dd-fc58a4fcbf41",
"productndc": "71209-008",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203266",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Jun 17, 2016"
}
],
"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": "ANDA203266",
"marketing_category": "ANDA",
"nonproprietary_name": "Gemfibrozil",
"start_marketing_date": "20160617",
"active_numerator_strength": "600"
}Related drugs
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