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United States · US · US:71335-0360_070b40e6-7d48-4193-a3c5-2599e3e6dbaf

Glyburide and Metformin Hydrochloride

Orange BookUNIISPLATC A10BB

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA10BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7133503601
    30 TABLET, FILM COATED in 1 BOTTLE (71335-0360-1)
  • ndc11
    7133503603
    60 TABLET, FILM COATED in 1 BOTTLE (71335-0360-3)
  • ndc11
    7133503604
    90 TABLET, FILM COATED in 1 BOTTLE (71335-0360-4)
  • ndc11
    7133503605
    120 TABLET, FILM COATED in 1 BOTTLE (71335-0360-5)
  • ndc11
    7133503606
    100 TABLET, FILM COATED in 1 BOTTLE (71335-0360-6)
  • ndc11
    7133503607
    180 TABLET, FILM COATED in 1 BOTTLE (71335-0360-7)
  • ndc11
    7133503608
    25 TABLET, FILM COATED in 1 BOTTLE (71335-0360-8)

Annotations

UNII (FDA Substance ID)
SX6K58TVWC
GLYBURIDE
RxCUI 4815
Orange Book
A077870
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": "71335-0360_070b40e6-7d48-4193-a3c5-2599e3e6dbaf",
  "productndc": "71335-0360",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077870",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.25MG;250MG",
        "product_no": "001",
        "approval_date": "Nov 14, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;500MG",
        "product_no": "002",
        "approval_date": "Nov 14, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;500MG",
        "product_no": "003",
        "approval_date": "Nov 14, 2007"
      }
    ],
    "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": "ANDA077870",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glyburide and Metformin Hydrochloride",
  "start_marketing_date": "20071114",
  "active_numerator_strength": "5; 500"
}

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