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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.

In shortageATC C03AAOrange 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…normalisedIrbesartan and HydrochlorothiazideATCC03AAREGISTER NO.US:43547-330_3e6f512c…PACKS LISTED3CHECKEDJune 3, 2026

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

  • ndc11
    4354733003
    30 TABLET in 1 BOTTLE (43547-330-03)
  • ndc11
    4354733009
    90 TABLET in 1 BOTTLE (43547-330-09)
  • ndc11
    4354733050
    500 TABLET in 1 BOTTLE (43547-330-50)

Regulatory notes

UNII (FDA substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A203072
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Hydrochlorothiazide; Quinapril Hydrochloride Tablet

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.