GLYBURIDE

In shortageOrange BookUNIISPLATC A10BB01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

CountryUS (United States)

ATC codeA10BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
2315505801
100 TABLET in 1 BOTTLE (23155-058-01)
ndc11
2315505810
1000 TABLET in 1 BOTTLE (23155-058-10)

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": "23155-058_98ed9f46-1633-4f82-bd51-ff87b0157871",
  "productndc": "23155-058",
  "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

Other records sharing ATC code A10BB01.

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