Lisinopril and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerExelan Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7628244801
100 TABLET in 1 BOTTLE (76282-448-01)
ndc11
7628244805
500 TABLET in 1 BOTTLE (76282-448-05)
ndc11
7628244810
1000 TABLET in 1 BOTTLE (76282-448-10)
ndc11
7628244890
90 TABLET in 1 BOTTLE (76282-448-90)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A204058

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": "76282-448_7f4a4f31-58b0-4fe1-bd11-ba5a6ac4f26c",
  "productndc": "76282-448",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204058",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;10MG",
        "product_no": "001",
        "approval_date": "May 23, 2017"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;20MG",
        "product_no": "002",
        "approval_date": "May 23, 2017"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;20MG",
        "product_no": "003",
        "approval_date": "May 23, 2017"
      }
    ],
    "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": "ANDA204058",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lisinopril and Hydrochlorothiazide Tablets",
  "start_marketing_date": "20190501",
  "active_numerator_strength": "25; 20"
}

Related drugs

Other records sharing ATC code C03AA.

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