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United States · US · US:71335-2508_e2fae12e-8044-43ad-994d-70ca0ad42174

glyburide-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
    7133525081
    30 TABLET in 1 BOTTLE (71335-2508-1)
  • ndc11
    7133525083
    60 TABLET in 1 BOTTLE (71335-2508-3)
  • ndc11
    7133525084
    90 TABLET in 1 BOTTLE (71335-2508-4)
  • ndc11
    7133525085
    120 TABLET in 1 BOTTLE (71335-2508-5)
  • ndc11
    7133525086
    100 TABLET in 1 BOTTLE (71335-2508-6)
  • ndc11
    7133525087
    180 TABLET in 1 BOTTLE (71335-2508-7)
  • ndc11
    7133525088
    25 TABLET in 1 BOTTLE (71335-2508-8)

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": "71335-2508_e2fae12e-8044-43ad-994d-70ca0ad42174",
  "productndc": "71335-2508",
  "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": "5; 500"
}

Related drugs

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