🇺🇸
United States · US · US:68382-653_05a184d3-8ed5-420f-8a0a-7a22c961d455
glyburide and metformin hydrochloride
Orange BookUNIISPLATC A10BB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeA10BB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116838265301100 TABLET in 1 BOTTLE (68382-653-01)
- ndc116838265305500 TABLET in 1 BOTTLE (68382-653-05)
- ndc11683826530630 TABLET in 1 BOTTLE (68382-653-06)
- ndc1168382653101000 TABLET in 1 BOTTLE (68382-653-10)
- ndc11683826531690 TABLET in 1 BOTTLE (68382-653-16)
- ndc11683826537710 BLISTER PACK in 1 CARTON (68382-653-77) / 10 TABLET in 1 BLISTER PACK (68382-653-30)
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": "68382-653_05a184d3-8ed5-420f-8a0a-7a22c961d455",
"productndc": "68382-653",
"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": "1.25; 250"
}Related drugs
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