Irbesartan and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
3334205806
3 BLISTER PACK in 1 CARTON (33342-058-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
3334205807
30 TABLET, FILM COATED in 1 BOTTLE (33342-058-07)
ndc11
3334205810
90 TABLET, FILM COATED in 1 BOTTLE (33342-058-10)
ndc11
3334205815
500 TABLET, FILM COATED in 1 BOTTLE (33342-058-15)
ndc11
3334205839
9 BLISTER PACK in 1 CARTON (33342-058-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A202414

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Hydrochlorothiazide; Quinapril Hydrochloride Tablet

Raw payload (JSON)

{
  "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": "33342-058_f2ef667a-4871-4f28-a0b3-3f79fbbe180c",
  "productndc": "33342-058",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202414",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;150MG",
        "product_no": "001",
        "approval_date": "Sep 27, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;300MG",
        "product_no": "002",
        "approval_date": "Sep 27, 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": "ANDA202414",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Irbesartan and Hydrochlorothiazide",
  "start_marketing_date": "20120927",
  "active_numerator_strength": "12.5; 300"
}

Related drugs

Other records sharing ATC code C03AA.

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