United States· US:43547-330_3e6f512c-8ff3-40b0-bcd3-9bf9bf26a112
Irbesartan and Hydrochlorothiazide
A thiazides, plain product containing irbesartan and hydrochlorothiazide, registered in United States by Solco Healthcare US, LLC.
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
- Irbesartan and Hydrochlorothiazide
- Manufacturer
- Solco Healthcare US, LLC
- Country
- United States (US)
- ATC code
- C03AA
- ATC class
- Thiazides, plain
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- June 3, 2026
Packs & prices · 3
- ndc11435473300330 TABLET in 1 BOTTLE (43547-330-03)
- ndc11435473300990 TABLET in 1 BOTTLE (43547-330-09)
- ndc114354733050500 TABLET in 1 BOTTLE (43547-330-50)
Regulatory notes
Same class
Other records under C03AA
Thiazides, plain, as other registers publish it.
- United StatesIrbesartan and HydrochlorothiazideBryant Ranch Prepack
- United StatesIrbesartan and HydrochlorothiazideSolco Healthcare US, LLC
- United StatesLisinopril and HydrochlorothiazideREMEDYREPACK INC.
- United StatesLisinopril and HydrochlorothiazideREMEDYREPACK INC.
- United StatesLisinopril and HydrochlorothiazideST. MARY'S MEDICAL PARK PHARMACY
- United StatesLisinopril and HydrochlorothiazideREMEDYREPACK INC.
- United StatesLosartan Potassium and HydrochlorothiazideST. MARY'S MEDICAL PARK PHARMACY
- United StatesTriamterene and HydrochlorothiazideSt Mary's Medical Park Pharmacy
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/be7b3282-3742-46c4-a933-407f96f24f62 GET /v1/drugs/be7b3282-3742-46c4-a933-407f96f24f62?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": "0J48LPH2TH",
"rxcui": "5487",
"inchikey": "JZUFKLXOESDKRF-UHFFFAOYSA-N",
"display_name": "HYDROCHLOROTHIAZIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"85494404-484c-45a1-8487-f9eb2a76490d": {
"match": "brand_token",
"title": "IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2026-06-01"
}
},
"productid": "43547-330_3e6f512c-8ff3-40b0-bcd3-9bf9bf26a112",
"productndc": "43547-330",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203072",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "12.5MG;150MG",
"product_no": "001",
"approval_date": "May 9, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "12.5MG;300MG",
"product_no": "002",
"approval_date": "May 9, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROCHLOROTHIAZIDE; IRBESARTAN",
"shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Irbesartan and Hydrochlorothiazide",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA203072",
"marketing_category": "ANDA",
"nonproprietary_name": "Irbesartan and Hydrochlorothiazide",
"start_marketing_date": "20140301",
"active_numerator_strength": "12.5; 150"
}See everything about irbesartan and hydrochlorothiazide.
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.