LISINOPRIL and HYDROCHLOROTHIAZIDE

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerGSMS, Incorporated

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5140756405
500 TABLET in 1 BOTTLE (51407-564-05)
ndc11
5140756490
90 TABLET in 1 BOTTLE (51407-564-90)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A076674

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": "51407-564_fd91c3d4-99e0-4b5d-8f6c-d08f19b64703",
  "productndc": "51407-564",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076674",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;10MG",
        "product_no": "001",
        "approval_date": "Oct 5, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;20MG",
        "product_no": "002",
        "approval_date": "Oct 5, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;20MG",
        "product_no": "003",
        "approval_date": "Oct 5, 2004"
      }
    ],
    "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": "ANDA076674",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LISINOPRIL and HYDROCHLOROTHIAZIDE",
  "start_marketing_date": "20250215",
  "active_numerator_strength": "12.5; 10"
}

Related drugs

Other records sharing ATC code C03AA.

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