🇺🇸
United States · US · US:68071-3950_486febc2-9999-d6bb-e063-6294a90a9a1e
glyburide-metformin hydrochloride
Orange BookUNIISPLATC A10BB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680713950330 TABLET in 1 BOTTLE (68071-3950-3)
Annotations
UNII (FDA Substance ID)
SX6K58TVWC
GLYBURIDE
RxCUI 4815
Orange Book
A079009
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": {
"b38213bb-d663-4c95-a1b2-96c23ee5be09": {
"match": "brand_token",
"title": "GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
"spl_version": "15",
"published_date": "2026-04-27"
}
},
"productid": "68071-3950_486febc2-9999-d6bb-e063-6294a90a9a1e",
"productndc": "68071-3950",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "079009",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1.25MG;250MG",
"product_no": "001",
"approval_date": "Jun 3, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG;500MG",
"product_no": "002",
"approval_date": "Jun 3, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG;500MG",
"product_no": "003",
"approval_date": "Jun 3, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"proprietary_name": "glyburide-metformin hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA079009",
"marketing_category": "ANDA",
"nonproprietary_name": "glyburide-metformin hydrochloride",
"start_marketing_date": "20240501",
"active_numerator_strength": "5; 500"
}Related drugs
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