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United States · US · US:23155-233_5b65cafb-4e53-4197-a872-c12ffdbc04e4

glyburide-metformin hydrochloride

Orange BookUNIISPLATC A10BB

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA10BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2315523301
    100 TABLET in 1 BOTTLE (23155-233-01)
  • ndc11
    2315523305
    500 TABLET in 1 BOTTLE (23155-233-05)
  • ndc11
    2315523310
    1000 TABLET in 1 BOTTLE (23155-233-10)

Annotations

UNII (FDA Substance ID)
SX6K58TVWC
GLYBURIDE
RxCUI 4815
Orange Book
A079009
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SX6K58TVWC",
    "rxcui": "4815",
    "inchikey": "ZNNLBTZKUZBEKO-UHFFFAOYSA-N",
    "display_name": "GLYBURIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b38213bb-d663-4c95-a1b2-96c23ee5be09": {
      "match": "brand_token",
      "title": "GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
      "spl_version": "15",
      "published_date": "2026-04-27"
    }
  },
  "productid": "23155-233_5b65cafb-4e53-4197-a872-c12ffdbc04e4",
  "productndc": "23155-233",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "079009",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.25MG;250MG",
        "product_no": "001",
        "approval_date": "Jun 3, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;500MG",
        "product_no": "002",
        "approval_date": "Jun 3, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;500MG",
        "product_no": "003",
        "approval_date": "Jun 3, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "glyburide-metformin hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA079009",
  "marketing_category": "ANDA",
  "nonproprietary_name": "glyburide-metformin hydrochloride",
  "start_marketing_date": "20240501",
  "active_numerator_strength": "1.25; 250"
}

Related drugs

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