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..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
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
- ndc116838218401100 TABLET, FILM COATED in 1 BOTTLE (68382-184-01)
- ndc1168382184101000 TABLET, FILM COATED in 1 BOTTLE (68382-184-10)
- ndc11683821841690 TABLET, FILM COATED in 1 BOTTLE (68382-184-16)
- ndc11683821847710 BLISTER PACK in 1 CARTON (68382-184-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-184-30)
Regulatory notes
Same class
Other records under A10BB
Sulfonylureas, as other registers publish it.
- United StatesGlipizide and Metformin HClHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- United StatesGlipizide and Metformin HClHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- United StatesGlipizide and Metformin HClHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- United StatesGlipizide and Metformin HydrochlorideZydus Pharmaceuticals USA Inc.
- United StatesGlipizide and Metformin HydrochlorideZydus Pharmaceuticals USA Inc.
- United Statesglyburide and metformin hydrochlorideZydus Lifesciences Limited
- United Statesglyburide and metformin hydrochlorideZydus Lifesciences Limited
- United Statesglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.
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.