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United States · US · US:43063-630_47d267f8-b7ad-6cc7-e063-6294a90a1c0a

Glimepiride

Orange BookUNIISPLATC A10BB12

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BB12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4306363030
    30 TABLET in 1 BOTTLE, PLASTIC (43063-630-30)
  • ndc11
    4306363090
    90 TABLET in 1 BOTTLE, PLASTIC (43063-630-90)

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": "43063-630_47d267f8-b7ad-6cc7-e063-6294a90a1c0a",
  "productndc": "43063-630",
  "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": "2"
}

Related drugs

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