Zestoretic

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerAlmatica Pharma Inc.

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5242743590
90 TABLET in 1 BOTTLE (52427-435-90)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

N019888

ABABAB

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": {
    "0d3a966f-f937-05a8-a90f-5aa52ebbd613": {
      "match": "brand_token",
      "title": "ZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]",
      "spl_version": "16",
      "published_date": "2025-06-02"
    }
  },
  "productid": "52427-435_b8a81227-c1af-6093-4d92-647ad3fee155",
  "productndc": "52427-435",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "019888",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG;20MG",
        "product_no": "001",
        "approval_date": "Sep 20, 1990"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG;20MG",
        "product_no": "002",
        "approval_date": "Jul 20, 1989"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG;10MG",
        "product_no": "003",
        "approval_date": "Nov 18, 1993"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; LISINOPRIL",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Zestoretic",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA019888",
  "marketing_category": "NDA",
  "nonproprietary_name": "lisinopril and hydrochlorothiazide",
  "start_marketing_date": "20150415",
  "active_numerator_strength": "12.5; 10"
}

Related drugs

Other records sharing ATC code C03AA.

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