QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6586216390
90 TABLET, FILM COATED in 1 BOTTLE (65862-163-90)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A078450

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": {
    "da562e3b-4411-e750-e053-2a95a90ad7e5": {
      "match": "brand_token",
      "title": "QUINAPRIL TABLET [NORTHWIND HEALTH COMPANY, LLC]",
      "spl_version": "2",
      "published_date": "2026-01-28"
    }
  },
  "productid": "65862-163_5842ecc2-874a-481b-8997-afa9d862dc5d",
  "productndc": "65862-163",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078450",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Aug 24, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Aug 24, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "Aug 24, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA078450",
  "marketing_category": "ANDA",
  "nonproprietary_name": "QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE",
  "start_marketing_date": "20070824",
  "active_numerator_strength": "25; 20"
}

Related drugs

Other records sharing ATC code C03AA.

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