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United States· US:57237-024_ca40b2d8-0009-46d0-9be4-64edd26b390b

Glyburide and Metformin Hydrochloride

A sulfonylureas product containing glyburide and metformin hydrochloride, registered in United States by Rising Pharma Holdings, Inc..

ATC A10BBOrange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedGlyburide and Metformin HydrochlorideATCA10BBREGISTER NO.US:57237-024_ca40b2d8…PACKS LISTED2CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Glyburide and Metformin Hydrochloride
Manufacturer
Rising Pharma Holdings, Inc.
Country
United States (US)
ATC code
A10BB
ATC class
Sulfonylureas
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 2

  • ndc11
    5723702401
    100 TABLET, FILM COATED in 1 BOTTLE (57237-024-01)
  • ndc11
    5723702405
    500 TABLET, FILM COATED in 1 BOTTLE (57237-024-05)

Regulatory notes

UNII (FDA substance ID)
SX6K58TVWC
GLYBURIDE
RxCUI 4815
Orange Book
A077870
ABABAB
DailyMed SPL labels
1 version tracked

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/ce5e9b27-4bb5-40f5-adeb-1250e0cec37f
GET /v1/drugs/ce5e9b27-4bb5-40f5-adeb-1250e0cec37f?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "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": "57237-024_ca40b2d8-0009-46d0-9be4-64edd26b390b",
  "productndc": "57237-024",
  "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"
}

See everything about glyburide and metformin hydrochloride.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.