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United States · US · US:68788-8791_d7d4d255-6028-4047-8907-75469f545f87

glyburide-metformin hydrochloride

Orange BookUNIISPLATC A10BB

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA10BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6878887911
    100 TABLET in 1 BOTTLE (68788-8791-1)
  • ndc11
    6878887913
    30 TABLET in 1 BOTTLE (68788-8791-3)
  • ndc11
    6878887916
    60 TABLET in 1 BOTTLE (68788-8791-6)
  • ndc11
    6878887918
    120 TABLET in 1 BOTTLE (68788-8791-8)
  • ndc11
    6878887919
    90 TABLET in 1 BOTTLE (68788-8791-9)

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": "68788-8791_d7d4d255-6028-4047-8907-75469f545f87",
  "productndc": "68788-8791",
  "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": "20241217",
  "active_numerator_strength": "5; 500"
}

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