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United States · US · US:68382-653_05a184d3-8ed5-420f-8a0a-7a22c961d455

glyburide and metformin hydrochloride

Orange BookUNIISPLATC A10BB

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

Identification

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

Packs · 6

  • ndc11
    6838265301
    100 TABLET in 1 BOTTLE (68382-653-01)
  • ndc11
    6838265305
    500 TABLET in 1 BOTTLE (68382-653-05)
  • ndc11
    6838265306
    30 TABLET in 1 BOTTLE (68382-653-06)
  • ndc11
    6838265310
    1000 TABLET in 1 BOTTLE (68382-653-10)
  • ndc11
    6838265316
    90 TABLET in 1 BOTTLE (68382-653-16)
  • ndc11
    6838265377
    10 BLISTER PACK in 1 CARTON (68382-653-77) / 10 TABLET in 1 BLISTER PACK (68382-653-30)

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": "68382-653_05a184d3-8ed5-420f-8a0a-7a22c961d455",
  "productndc": "68382-653",
  "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": "1.25; 250"
}

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