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United States · US · US:63187-486_d49136d3-d03e-4ed6-88ab-05cce831e7fe

Glimepiride

Orange BookUNIISPLATC A10BB12

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA10BB12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6318748630
    30 TABLET in 1 BOTTLE (63187-486-30)
  • ndc11
    6318748660
    60 TABLET in 1 BOTTLE (63187-486-60)
  • ndc11
    6318748690
    90 TABLET in 1 BOTTLE (63187-486-90)

Annotations

UNII (FDA Substance ID)
6KY687524K
GLIMEPIRIDE
RxCUI 25789
Orange Book
A078181
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6KY687524K",
    "rxcui": "25789",
    "inchikey": "WIGIZIANZCJQQY-RUCARUNLSA-N",
    "display_name": "GLIMEPIRIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9e863f84-d6f2-4d61-8250-774569e84353": {
      "match": "brand_token",
      "title": "GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "12",
      "published_date": "2026-05-21"
    }
  },
  "productid": "63187-486_d49136d3-d03e-4ed6-88ab-05cce831e7fe",
  "productndc": "63187-486",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078181",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Aug 23, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Aug 23, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "003",
        "approval_date": "Aug 23, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLIMEPIRIDE",
  "proprietary_name": "Glimepiride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078181",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glimepiride",
  "start_marketing_date": "20070823",
  "active_numerator_strength": "4"
}

Related drugs

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