🇺🇸
United States · US · US:50090-0887_0797d374-f582-4573-8a17-8d55185be64d
Glyburide and Metformin Hydrochloride
Orange BookUNIISPLATC A10BB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA10BB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11500900887060 TABLET, FILM COATED in 1 BOTTLE (50090-0887-0)
- ndc11500900887130 TABLET, FILM COATED in 1 BOTTLE (50090-0887-1)
- ndc115009008872180 TABLET, FILM COATED in 1 BOTTLE (50090-0887-2)
- ndc11500900887390 TABLET, FILM COATED in 1 BOTTLE (50090-0887-3)
Annotations
UNII (FDA Substance ID)
SX6K58TVWC
GLYBURIDE
RxCUI 4815
Orange Book
A077870
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "SX6K58TVWC",
"rxcui": "4815",
"inchikey": "ZNNLBTZKUZBEKO-UHFFFAOYSA-N",
"display_name": "GLYBURIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2239742b-74e1-4bc2-b5a8-15c4758d6f7b": {
"match": "brand_token",
"title": "GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]",
"spl_version": "6",
"published_date": "2026-05-22"
}
},
"productid": "50090-0887_0797d374-f582-4573-8a17-8d55185be64d",
"productndc": "50090-0887",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077870",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1.25MG;250MG",
"product_no": "001",
"approval_date": "Nov 14, 2007"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "2.5MG;500MG",
"product_no": "002",
"approval_date": "Nov 14, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG;500MG",
"product_no": "003",
"approval_date": "Nov 14, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"proprietary_name": "Glyburide and Metformin Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA077870",
"marketing_category": "ANDA",
"nonproprietary_name": "Glyburide and Metformin Hydrochloride",
"start_marketing_date": "20071114",
"active_numerator_strength": "2.5; 500"
}Related drugs
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