Lisinopril and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerActavis Pharma, Inc.

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0591086201
100 TABLET in 1 BOTTLE, PLASTIC (0591-0862-01)
ndc11
0591086205
500 TABLET in 1 BOTTLE, PLASTIC (0591-0862-05)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A076194

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": {
    "ab561d21-7466-4d8b-8d06-291c1d4d82ff": {
      "match": "brand_token",
      "title": "LISINOPRIL TABLET [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "9",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0591-0862_ab203e31-9939-4e72-8ccd-ed55261bfb65",
  "productndc": "0591-0862",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076194",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;20MG",
        "product_no": "001",
        "approval_date": "Jul 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;20MG",
        "product_no": "002",
        "approval_date": "Jul 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;10MG",
        "product_no": "003",
        "approval_date": "Jul 1, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; LISINOPRIL",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Lisinopril and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076194",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lisinopril and Hydrochlorothiazide",
  "start_marketing_date": "20030304",
  "active_numerator_strength": "25; 20"
}

Related drugs

Other records sharing ATC code C03AA.

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