🇺🇸
United States · US · US:65841-825_bbe22462-20b4-4cef-a224-b00781a17922
glyburide and metformin hydrochloride
Orange BookUNIISPLATC A10BB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeA10BB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116584182501100 TABLET in 1 BOTTLE (65841-825-01)
- ndc116584182505500 TABLET in 1 BOTTLE (65841-825-05)
- ndc11658418250630 TABLET in 1 BOTTLE (65841-825-06)
- ndc1165841825101000 TABLET in 1 BOTTLE (65841-825-10)
- ndc11658418251690 TABLET in 1 BOTTLE (65841-825-16)
- ndc11658418257710 BLISTER PACK in 1 CARTON (65841-825-77) / 10 TABLET in 1 BLISTER PACK (65841-825-30)
Annotations
UNII (FDA Substance ID)
SX6K58TVWC
GLYBURIDE
RxCUI 4815
Orange Book
A206748
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": "65841-825_bbe22462-20b4-4cef-a224-b00781a17922",
"productndc": "65841-825",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206748",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1.25MG;250MG",
"product_no": "001",
"approval_date": "Feb 29, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG;500MG",
"product_no": "002",
"approval_date": "Feb 29, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG;500MG",
"product_no": "003",
"approval_date": "Feb 29, 2016"
}
],
"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": "ANDA206748",
"marketing_category": "ANDA",
"nonproprietary_name": "glyburide and metformin hydrochloride",
"start_marketing_date": "20160407",
"active_numerator_strength": "2.5; 500"
}Related drugs
Other records sharing ATC code A10BB.
- 🇺🇸DuetactTakeda Pharmaceuticals America, Inc.
- 🇺🇸DuetactTakeda Pharmaceuticals America, Inc.
- 🇺🇸Glipizide and metformin hclChartwell RX, LLC
- 🇺🇸Glipizide and metformin hclChartwell RX, LLC
- 🇺🇸Glipizide and metformin hclChartwell RX, LLC
- 🇺🇸Glipizide and Metformin HClHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- 🇺🇸Glipizide and Metformin HClHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- 🇺🇸Glipizide and Metformin HClHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Access this data programmatically
Query glyburide and metformin hydrochloride 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.