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United States · US · US:68084-326_26cca05b-82f8-e191-e063-6394a90a56bd

Glimepiride

Orange BookUNIISPLATC A10BB12

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeA10BB12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6808432601
    100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-326-01) / 1 TABLET in 1 BLISTER PACK (68084-326-11)

Annotations

UNII (FDA Substance ID)
6KY687524K
GLIMEPIRIDE
RxCUI 25789
Orange Book
A077091
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": "68084-326_26cca05b-82f8-e191-e063-6394a90a56bd",
  "productndc": "68084-326",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077091",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Oct 6, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Oct 6, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "003",
        "approval_date": "Oct 6, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLIMEPIRIDE",
  "proprietary_name": "Glimepiride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077091",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glimepiride",
  "start_marketing_date": "20090422",
  "active_numerator_strength": "2"
}

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