Lisinopril and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerLegacy Pharmaceutical Packaging, LLC

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6864555754
30 TABLET in 1 BOTTLE (68645-557-54)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A077912

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": "68645-557_4c4ae743-258c-e380-e063-6394a90af48a",
  "productndc": "68645-557",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077912",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;10MG",
        "product_no": "001",
        "approval_date": "Sep 27, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;20MG",
        "product_no": "002",
        "approval_date": "Sep 27, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;20MG",
        "product_no": "003",
        "approval_date": "Sep 27, 2006"
      }
    ],
    "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": "ANDA077912",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lisinopril and Hydrochlorothiazide",
  "start_marketing_date": "20060410",
  "active_numerator_strength": "12.5; 20"
}

Related drugs

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