glyburide

In shortageOrange BookUNIISPLATC A10BB01

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeA10BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6584183301
100 TABLET in 1 BOTTLE (65841-833-01)
ndc11
6584183305
500 TABLET in 1 BOTTLE (65841-833-05)
ndc11
6584183306
30 TABLET in 1 BOTTLE (65841-833-06)
ndc11
6584183310
1000 TABLET in 1 BOTTLE (65841-833-10)
ndc11
6584183316
90 TABLET in 1 BOTTLE (65841-833-16)
ndc11
6584183377
10 BLISTER PACK in 1 CARTON (65841-833-77) / 10 TABLET in 1 BLISTER PACK (65841-833-30)

Annotations

UNII (FDA Substance ID)

SX6K58TVWC

GLYBURIDE

RxCUI 4815

Orange Book

A206749

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": "65841-833_0450d056-3523-44c3-a4cf-f4557e520ce5",
  "productndc": "65841-833",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206749",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "1.25MG",
        "product_no": "001",
        "approval_date": "May 10, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "May 10, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "May 10, 2016"
      }
    ],
    "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": "ANDA206749",
  "marketing_category": "ANDA",
  "nonproprietary_name": "glyburide",
  "start_marketing_date": "20160602",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code A10BB01.

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