Irbesartan and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerSolco Healthcare US, LLC

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4354733103
30 TABLET in 1 BOTTLE (43547-331-03)
ndc11
4354733109
90 TABLET in 1 BOTTLE (43547-331-09)
ndc11
4354733150
500 TABLET in 1 BOTTLE (43547-331-50)

Annotations

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

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": "43547-331_3e6f512c-8ff3-40b0-bcd3-9bf9bf26a112",
  "productndc": "43547-331",
  "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; 300"
}

Related drugs

Other records sharing ATC code C03AA.

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