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United States · US · US:0049-0174_ce46d6b5-eab4-4630-8480-f13885be938e

Glucotrol

In shortageOrange BookUNIISPLATC A10BB07

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

Identification

ManufacturerRoerig
CountryUS (United States)
ATC codeA10BB07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0049017402
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-02)
  • ndc11
    0049017403
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-03)

Annotations

UNII (FDA Substance ID)
X7WDT95N5C
GLIPIZIDE
RxCUI 4821
Orange Book
N020329
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Glipizide Tablet, Extended Release
Raw payload (JSON)
{
  "unii": {
    "unii": "X7WDT95N5C",
    "rxcui": "4821",
    "inchikey": "ZJJXGWJIGJFDTL-UHFFFAOYSA-N",
    "display_name": "GLIPIZIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "eed99b60-d043-4249-9b2a-f05e46fb588d": {
      "match": "brand_token",
      "title": "GLUCOTROL XL (GLIPIZIDE) TABLET, EXTENDED RELEASE [ROERIG]",
      "spl_version": "27",
      "published_date": "2025-04-07"
    }
  },
  "productid": "0049-0174_ce46d6b5-eab4-4630-8480-f13885be938e",
  "productndc": "0049-0174",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020329",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 26, 1994"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Apr 26, 1994"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2.5MG",
        "product_no": "003",
        "approval_date": "Aug 10, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLIPIZIDE",
  "shortage_reason": "Glipizide Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Glucotrol",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020329",
  "marketing_category": "NDA",
  "nonproprietary_name": "glipizide",
  "start_marketing_date": "20130509",
  "active_numerator_strength": "5"
}

Related drugs

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