Lisinopril/HCTZ

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerDirect_Rx

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7218965130
30 TABLET in 1 BOTTLE (72189-651-30)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A076230

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": {
    "4510c108-2683-f505-e063-6394a90ab0a4": {
      "match": "brand_token",
      "title": "LISINOPRIL/HCTZ TABLET [DIRECT_RX]",
      "spl_version": "1",
      "published_date": "2025-12-04"
    }
  },
  "productid": "72189-651_4510c108-2684-f505-e063-6394a90ab0a4",
  "productndc": "72189-651",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076230",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;10MG",
        "product_no": "001",
        "approval_date": "Jul 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;20MG",
        "product_no": "002",
        "approval_date": "Jul 1, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;20MG",
        "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/HCTZ",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076230",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lisinopril/HCTZ",
  "start_marketing_date": "20251203",
  "active_numerator_strength": "12.5; 20"
}

Related drugs

Other records sharing ATC code C03AA.

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