Spironolactone and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerPrasco Laboratories

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6699318802
100 TABLET, FILM COATED in 1 BOTTLE (66993-188-02)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

N012616

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": {
    "3487305c-25a6-4e82-923c-3e4dd638c988": {
      "match": "brand_token",
      "title": "SPIRONOLACTONE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "16",
      "published_date": "2026-06-01"
    }
  },
  "productid": "66993-188_eca75090-9808-4673-bd7e-1ecd571d3b3e",
  "productndc": "66993-188",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "012616",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG;25MG",
        "product_no": "004",
        "approval_date": "Dec 30, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG;50MG",
        "product_no": "005",
        "approval_date": "Dec 30, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; SPIRONOLACTONE",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Spironolactone and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA012616",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "spironolactone and hydrochlorothiazide",
  "start_marketing_date": "20211129",
  "active_numerator_strength": "25; 25"
}

Related drugs

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