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United States · US · US:71610-236_51de9fdb-99a3-41a6-a7ef-ec6c5f819088

Glimepiride

Orange BookUNIISPLATC A10BB12

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeA10BB12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7161023660
    90 TABLET in 1 BOTTLE (71610-236-60)
  • ndc11
    7161023680
    180 TABLET in 1 BOTTLE (71610-236-80)

Annotations

UNII (FDA Substance ID)
6KY687524K
GLIMEPIRIDE
RxCUI 25789
Orange Book
A077911
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": "71610-236_51de9fdb-99a3-41a6-a7ef-ec6c5f819088",
  "productndc": "71610-236",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077911",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Sep 22, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Sep 22, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "003",
        "approval_date": "Sep 22, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLIMEPIRIDE",
  "proprietary_name": "Glimepiride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077911",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glimepiride",
  "start_marketing_date": "20090817",
  "active_numerator_strength": "4"
}

Related drugs

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