Back to search
🇺🇸

United States · US · US:50090-0887_0797d374-f582-4573-8a17-8d55185be64d

Glyburide and Metformin Hydrochloride

Orange BookUNIISPLATC A10BB

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA10BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5009008870
    60 TABLET, FILM COATED in 1 BOTTLE (50090-0887-0)
  • ndc11
    5009008871
    30 TABLET, FILM COATED in 1 BOTTLE (50090-0887-1)
  • ndc11
    5009008872
    180 TABLET, FILM COATED in 1 BOTTLE (50090-0887-2)
  • ndc11
    5009008873
    90 TABLET, FILM COATED in 1 BOTTLE (50090-0887-3)

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": "50090-0887_0797d374-f582-4573-8a17-8d55185be64d",
  "productndc": "50090-0887",
  "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": "2.5; 500"
}

Related drugs

Other records sharing ATC code A10BB.

Access this data programmatically

Query Glyburide and Metformin Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.