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United States · US · US:75834-203_757b12d9-8efb-49ca-b8f7-7884535ca011
GLYBURIDE
In shortageOrange BookUNIISPLATC A10BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNivagen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1175834203001000 TABLET in 1 BOTTLE (75834-203-00)
- ndc117583420301100 TABLET in 1 BOTTLE (75834-203-01)
Annotations
UNII (FDA Substance ID)
SX6K58TVWC
GLYBURIDE
RxCUI 4815
Orange Book
A203379
AB1AB1AB1
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Glyburide Tablet
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": "75834-203_757b12d9-8efb-49ca-b8f7-7884535ca011",
"productndc": "75834-203",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203379",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "1.25MG",
"product_no": "001",
"approval_date": "Jan 4, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "2.5MG",
"product_no": "002",
"approval_date": "Jan 4, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "5MG",
"product_no": "003",
"approval_date": "Jan 4, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLYBURIDE",
"shortage_reason": "Glyburide Tablet",
"shortage_status": "current",
"proprietary_name": "GLYBURIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203379",
"marketing_category": "ANDA",
"nonproprietary_name": "GLYBURIDE",
"start_marketing_date": "20190125",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code A10BB01.
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