🇺🇸
United States · US · US:71335-0360_070b40e6-7d48-4193-a3c5-2599e3e6dbaf
Glyburide and Metformin Hydrochloride
Orange BookUNIISPLATC A10BB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA10BB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc11713350360130 TABLET, FILM COATED in 1 BOTTLE (71335-0360-1)
- ndc11713350360360 TABLET, FILM COATED in 1 BOTTLE (71335-0360-3)
- ndc11713350360490 TABLET, FILM COATED in 1 BOTTLE (71335-0360-4)
- ndc117133503605120 TABLET, FILM COATED in 1 BOTTLE (71335-0360-5)
- ndc117133503606100 TABLET, FILM COATED in 1 BOTTLE (71335-0360-6)
- ndc117133503607180 TABLET, FILM COATED in 1 BOTTLE (71335-0360-7)
- ndc11713350360825 TABLET, FILM COATED in 1 BOTTLE (71335-0360-8)
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": "71335-0360_070b40e6-7d48-4193-a3c5-2599e3e6dbaf",
"productndc": "71335-0360",
"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": "5; 500"
}Related drugs
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