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United States · US · US:68788-4073_bc8df889-25e0-49a0-bbec-a3dfae8bbb8a
Glyburide
In shortageOrange BookUNIISPLATC A10BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA10BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116878840731100 TABLET in 1 BOTTLE (68788-4073-1)
- ndc11687884073330 TABLET in 1 BOTTLE (68788-4073-3)
- ndc11687884073660 TABLET in 1 BOTTLE (68788-4073-6)
- ndc11687884073990 TABLET in 1 BOTTLE (68788-4073-9)
Annotations
UNII (FDA Substance ID)
SX6K58TVWC
GLYBURIDE
RxCUI 4815
Orange Book
A074388
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": "68788-4073_bc8df889-25e0-49a0-bbec-a3dfae8bbb8a",
"productndc": "68788-4073",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "074388",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "1.25MG",
"product_no": "001",
"approval_date": "Aug 29, 1995"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "2.5MG",
"product_no": "002",
"approval_date": "Aug 29, 1995"
},
{
"rs": true,
"rld": false,
"te_code": "AB1",
"strength": "5MG",
"product_no": "003",
"approval_date": "Aug 29, 1995"
}
],
"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": "ANDA074388",
"marketing_category": "ANDA",
"nonproprietary_name": "Glyburide",
"start_marketing_date": "20260127",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code A10BB01.
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