🇺🇸
United States · US · US:71335-0051_cc153611-a05f-4d96-8132-1b7da12f24fb
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
- ndc11713350051160 TABLET in 1 BOTTLE (71335-0051-1)
- ndc11713350051230 TABLET in 1 BOTTLE (71335-0051-2)
- ndc117133500513100 TABLET in 1 BOTTLE (71335-0051-3)
- ndc11713350051490 TABLET in 1 BOTTLE (71335-0051-4)
- ndc117133500515180 TABLET in 1 BOTTLE (71335-0051-5)
Annotations
UNII (FDA Substance ID)
Q8X02027X3
GEMFIBROZIL
RxCUI 4719
Orange Book
A078012
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": "71335-0051_cc153611-a05f-4d96-8132-1b7da12f24fb",
"productndc": "71335-0051",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078012",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Mar 26, 2007"
}
],
"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": "ANDA078012",
"marketing_category": "ANDA",
"nonproprietary_name": "GEMFIBROZIL",
"start_marketing_date": "20170323",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code C10AB04.
- 🇺🇸GemfibrozilBryant Ranch Prepack
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- 🇺🇸GemfibrozilPD-Rx Pharmaceuticals, Inc.
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- 🇺🇸GemfibrozilAphena Pharma Solutions - Tennessee, LLC
- 🇺🇸GemfibrozilA-S Medication Solutions
- 🇺🇸GemfibrozilProficient Rx LP
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