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United States· US:68382-184_e7654a95-e73f-4bfb-b7cd-eb85450d8c4c

Glipizide and Metformin Hydrochloride

A sulfonylureas product containing glipizide and metformin hydrochloride, registered in United States by Zydus Pharmaceuticals USA 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…normalisedGlipizide and Metformin HydrochlorideATCA10BBREGISTER NO.US:68382-184_e7654a95…PACKS LISTED4CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Glipizide and Metformin Hydrochloride
Manufacturer
Zydus Pharmaceuticals USA 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 · 4

  • ndc11
    6838218401
    100 TABLET, FILM COATED in 1 BOTTLE (68382-184-01)
  • ndc11
    6838218410
    1000 TABLET, FILM COATED in 1 BOTTLE (68382-184-10)
  • ndc11
    6838218416
    90 TABLET, FILM COATED in 1 BOTTLE (68382-184-16)
  • ndc11
    6838218477
    10 BLISTER PACK in 1 CARTON (68382-184-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-184-30)

Regulatory notes

UNII (FDA substance ID)
X7WDT95N5C
GLIPIZIDE
RxCUI 4821
Orange Book
A078905
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/be7b3f30-593f-4d71-87c2-b878f2248e35
GET /v1/drugs/be7b3f30-593f-4d71-87c2-b878f2248e35?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": "X7WDT95N5C",
    "rxcui": "4821",
    "inchikey": "ZJJXGWJIGJFDTL-UHFFFAOYSA-N",
    "display_name": "GLIPIZIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9b405ff3-6ce5-460a-9406-db92e0e6ab1b": {
      "match": "brand_token",
      "title": "GLIPIZIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "1",
      "published_date": "2026-05-25"
    }
  },
  "productid": "68382-184_e7654a95-e73f-4bfb-b7cd-eb85450d8c4c",
  "productndc": "68382-184",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078905",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;250MG",
        "product_no": "001",
        "approval_date": "Jan 31, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;500MG",
        "product_no": "002",
        "approval_date": "Jan 31, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;500MG",
        "product_no": "003",
        "approval_date": "Jan 31, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLIPIZIDE; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Glipizide and Metformin Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA078905",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glipizide and Metformin Hydrochloride",
  "start_marketing_date": "20160505",
  "active_numerator_strength": "2.5; 250"
}

See everything about glipizide 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.