United States· US:53489-329_d58f76e0-60c3-42ec-8375-128cd42485f1

SPIRONOLACTONE

A spironolactone product containing spironolactone, registered in United States by Sun Pharmaceutical Industries, Inc.. The same ATC class is registered in 18 of our 19 countries.

In shortageATC C03DA01Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedSPIRONOLACTONEATCC03DA01REGISTER NO.US:53489-329_d58f76e0…PACKS LISTED7CHECKEDSeptember 12, 2026

Where it is registered

Spironolactone is registered in 18 of 19 countries.

Countries holding a registration under ATC C03DA01 (spironolactone), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 10 of them publish a price we can compare per daily dose

Spironolactone · ATC C03DA01

18 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of spironolactone costs, country by country.

Normalised to the WHO defined daily dose (37.5 mg), the median price runs from $0.064 in United States to $0.29 in Switzerland — a ×4.5 gap.

  • United States: $0.064 per daily dose (median across products in the class)
  • Public list prices, converted to USD at the rate date shown
  • US figures are pharmacy acquisition cost (CMS NADAC), not retail

Spironolactone · price per daily dose (37.5 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$0.29
  • IT Italy$0.17
  • FR France$0.088
  • US United States$0.064 (acquisition cost)
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
SPIRONOLACTONE
Manufacturer
Sun Pharmaceutical Industries, Inc.
Country
United States (US)
ATC code
C03DA01
ATC class
Spironolactone
Defined daily dose
37.5 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 7

  • ndc11
    5348932901
    100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-01)
  • ndc11
    5348932902
    50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-02)
  • ndc11
    5348932903
    250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-03)
  • ndc11
    5348932905
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-05)
  • ndc11
    5348932906
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-06)
  • ndc11
    5348932907
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-07)
  • ndc11
    5348932910
    1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-10)

Regulatory notes

UNII (FDA substance ID)
27O7W4T232
SPIRONOLACTONE
RxCUI 9997
Orange Book
A089424
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Spironolactone Tablet

Interactions

454 interactions on record for spironolactone.

Graded by severity as the source publishes them — 14 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Spironolactone · interactions on record

454 records

  • 14 severe
  • 150 moderate
  • 15 minor
  • 191 info

Most severe, free to view

  • LoperamideA07DA03severe
  • Potassium chlorideA12BA01severe
  • Potassium citrateA12BA02severe
  • Potassium gluconateA12BA05severe

84 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Spironolactone in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All spironolactone products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Aldactone, Spirobene
  • Belgium · Aldactone, Spironolactone Eg
  • Bulgaria · Спилактон, Спиронолактон Акорд
  • Cyprus · Spiro, Spirolon
  • Czechia · Spironolactone Medreg, Spironolactone Orion
  • Germany · Aldactone, Spirobeta
  • Denmark · Spirix, Spiron
  • Estonia · Spirix, Spironolactone Accord
  • Spain · Aldactone, Espironolactona Accord
  • Finland · Spirix, Spironolactone Orion
  • France · Aldactone, Spironolactone Arrow
  • United Kingdom (Northern Ireland) · Aldactone, Spironolactone Accord Healthcare
  • Greece · Aldactone
  • Croatia · Aldactone
  • Hungary · Spiron, Spironolactone Orion
  • Ireland · Aldactone, Spironolactone Accord Healthcare Ireland
  • Iceland · Spirix, Spiron
  • Italy · Aldactone, Spirolang
  • Lithuania · Spirix, Spironolactone Accord
  • Luxembourg · Aldactone, Spironolacton Ratiopharm
  • Latvia · Spirix, Spironolactone Accord
  • Malta · Aldactone, Spirolon
  • Netherlands · Spironolacton Accord, Spironolacton Genrx
  • Norway · Spirix, Spironolactone Orion
  • Poland · Finospir, Spironol
  • Portugal · Aldactone, Espironolactona Alter
  • Romania · Alspiron, Spironolactonă Arena
  • Sweden · Spironolactone Accord, Spironolactone Orion
  • Slovenia · Aldactone, Spironolakton Orion
  • Slovakia · Medospir, Spironolactone Accord

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/d19dd39c-3dbe-44fa-9504-a2f03dbeb22a
GET /v1/drugs/d19dd39c-3dbe-44fa-9504-a2f03dbeb22a?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "27O7W4T232",
    "rxcui": "9997",
    "inchikey": "LXMSZDCAJNLERA-ZHYRCANASA-N",
    "display_name": "SPIRONOLACTONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 4
  },
  "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": "53489-329_d58f76e0-60c3-42ec-8375-128cd42485f1",
  "productndc": "53489-329",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "089424",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jul 23, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Aug 11, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Aug 11, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SPIRONOLACTONE",
  "shortage_reason": "Spironolactone Tablet",
  "shortage_status": "current",
  "proprietary_name": "SPIRONOLACTONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA089424",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SPIRONOLACTONE",
  "start_marketing_date": "19860723",
  "active_numerator_strength": "100"
}

See everything about spironolactone.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.