United States· US:71335-1097_04ca597a-0797-4dd7-b85e-9d9bdcad68c3

Irbesartan and Hydrochlorothiazide

A thiazides, plain product containing irbesartan and hydrochlorothiazide, registered in United States by Bryant Ranch Prepack.

In shortageATC C03AAOrange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: Irbesartan and Hydrochlorothiazide
Manufacturer: Bryant Ranch Prepack
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
7133510971
30 TABLET, FILM COATED in 1 BOTTLE (71335-1097-1)
ndc11
7133510972
90 TABLET, FILM COATED in 1 BOTTLE (71335-1097-2)
ndc11
7133510973
28 TABLET, FILM COATED in 1 BOTTLE (71335-1097-3)

Regulatory notes

UNII (FDA substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A077369

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Hydrochlorothiazide; Quinapril Hydrochloride Tablet

Same class

Other records under C03AA

Thiazides, plain, as other registers publish it.

All irbesartan and hydrochlorothiazide products

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/628bb2a6-dbc5-4aa6-8ec9-86e18c97e26b
GET /v1/drugs/628bb2a6-dbc5-4aa6-8ec9-86e18c97e26b?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": "71335-1097_04ca597a-0797-4dd7-b85e-9d9bdcad68c3",
  "productndc": "71335-1097",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077369",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;150MG",
        "product_no": "001",
        "approval_date": "Mar 30, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;300MG",
        "product_no": "002",
        "approval_date": "Mar 30, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG;300MG",
        "product_no": "003",
        "approval_date": "Mar 30, 2012"
      }
    ],
    "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": "ANDA077369",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Irbesartan and Hydrochlorothiazide",
  "start_marketing_date": "20130124",
  "active_numerator_strength": "12.5; 150"
}

API reference MCP server Plans

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