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United States · US · US:71335-0150_5e1bb26d-3543-48d5-9a08-c07f5dd5a688

GLYBURIDE

In shortageOrange BookUNIISPLATC A10BB01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA10BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7133501501
    30 TABLET in 1 BOTTLE (71335-0150-1)
  • ndc11
    7133501502
    120 TABLET in 1 BOTTLE (71335-0150-2)
  • ndc11
    7133501503
    100 TABLET in 1 BOTTLE (71335-0150-3)
  • ndc11
    7133501504
    60 TABLET in 1 BOTTLE (71335-0150-4)
  • ndc11
    7133501505
    90 TABLET in 1 BOTTLE (71335-0150-5)
  • ndc11
    7133501506
    180 TABLET in 1 BOTTLE (71335-0150-6)

Annotations

UNII (FDA Substance ID)
SX6K58TVWC
GLYBURIDE
RxCUI 4815
Orange Book
A090937
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": "71335-0150_5e1bb26d-3543-48d5-9a08-c07f5dd5a688",
  "productndc": "71335-0150",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090937",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "1.25MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "Feb 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Feb 28, 2011"
      }
    ],
    "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": "ANDA090937",
  "marketing_category": "ANDA",
  "nonproprietary_name": "GLYBURIDE",
  "start_marketing_date": "20101005",
  "active_numerator_strength": "5"
}

Related drugs

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