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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

  • ndc11
    6878840731
    100 TABLET in 1 BOTTLE (68788-4073-1)
  • ndc11
    6878840733
    30 TABLET in 1 BOTTLE (68788-4073-3)
  • ndc11
    6878840736
    60 TABLET in 1 BOTTLE (68788-4073-6)
  • ndc11
    6878840739
    90 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

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