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United States · US · US:71335-0069_6f8e3fb8-cf23-4eae-8a95-dbd75698a58b

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 · 3

  • ndc11
    7133500691
    30 TABLET in 1 BOTTLE (71335-0069-1)
  • ndc11
    7133500692
    60 TABLET in 1 BOTTLE (71335-0069-2)
  • ndc11
    7133500693
    90 TABLET in 1 BOTTLE (71335-0069-3)

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": "71335-0069_6f8e3fb8-cf23-4eae-8a95-dbd75698a58b",
  "productndc": "71335-0069",
  "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": "2.5"
}

Related drugs

Other records sharing ATC code A10BB01.

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