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United States · US · US:65841-825_bbe22462-20b4-4cef-a224-b00781a17922

glyburide and metformin hydrochloride

Orange BookUNIISPLATC A10BB

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeA10BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    6584182501
    100 TABLET in 1 BOTTLE (65841-825-01)
  • ndc11
    6584182505
    500 TABLET in 1 BOTTLE (65841-825-05)
  • ndc11
    6584182506
    30 TABLET in 1 BOTTLE (65841-825-06)
  • ndc11
    6584182510
    1000 TABLET in 1 BOTTLE (65841-825-10)
  • ndc11
    6584182516
    90 TABLET in 1 BOTTLE (65841-825-16)
  • ndc11
    6584182577
    10 BLISTER PACK in 1 CARTON (65841-825-77) / 10 TABLET in 1 BLISTER PACK (65841-825-30)

Annotations

UNII (FDA Substance ID)
SX6K58TVWC
GLYBURIDE
RxCUI 4815
Orange Book
A206748
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": {
    "2239742b-74e1-4bc2-b5a8-15c4758d6f7b": {
      "match": "brand_token",
      "title": "GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]",
      "spl_version": "6",
      "published_date": "2026-05-22"
    }
  },
  "productid": "65841-825_bbe22462-20b4-4cef-a224-b00781a17922",
  "productndc": "65841-825",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206748",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.25MG;250MG",
        "product_no": "001",
        "approval_date": "Feb 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;500MG",
        "product_no": "002",
        "approval_date": "Feb 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;500MG",
        "product_no": "003",
        "approval_date": "Feb 29, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "glyburide and metformin hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA206748",
  "marketing_category": "ANDA",
  "nonproprietary_name": "glyburide and metformin hydrochloride",
  "start_marketing_date": "20160407",
  "active_numerator_strength": "2.5; 500"
}

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