Glyburide

In shortageOrange BookUNIISPLATC A10BB01

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

Identification

ManufacturerCoupler LLC

CountryUS (United States)

ATC codeA10BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6704616203
30 TABLET in 1 BLISTER PACK (67046-1620-3)

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": "67046-1620_4573af53-70f9-b5d7-e063-6294a90af2e0",
  "productndc": "67046-1620",
  "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": "20251208",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code A10BB01.

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