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United States · US · US:0093-9477_84b83205-8813-494e-933e-a70697393744

Glyburide

In shortageOrange BookUNIISPLATC A10BB01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTEVA Pharmaceuticals USA Inc
CountryUS (United States)
ATC codeA10BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0093947753
    50 TABLET in 1 BOTTLE (0093-9477-53)

Annotations

UNII (FDA Substance ID)
SX6K58TVWC
GLYBURIDE
RxCUI 4815
Orange Book
N017532
AB2AB2AB2
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": "0093-9477_84b83205-8813-494e-933e-a70697393744",
  "productndc": "0093-9477",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "017532",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "1.25MG",
        "product_no": "001",
        "approval_date": "May 1, 1984"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "May 1, 1984"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB2",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "May 1, 1984"
      }
    ],
    "appl_type": "N"
  },
  "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": "NDA017532",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "glyburide",
  "start_marketing_date": "19840501",
  "active_numerator_strength": "1.25"
}

Related drugs

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