United States· US:55154-7991_dde61426-7d3b-40a3-9fd4-f654bfb75693

Isosorbide Dinitrate

A isosorbide dinitrate product containing isosorbide dinitrate, registered in United States by Cardinal Health 107, LLC. The same ATC class is registered in 2 of our 19 countries.

ATC C05AE02Orange BookUS label

Checked against FDA National Drug Code directory (United States) on September 12, 2026

Informational only — not a medical device.

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Where it is registered

Isosorbide dinitrate is registered in 2 of 19 countries.

Countries holding a registration under ATC C05AE02 (isosorbide dinitrate), each read from that country’s own register.

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

Search isosorbide dinitrate products by name

Isosorbide dinitrate · ATC C05AE02

2 / 19 countries

Netherlands
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.

The record

At a glance

FDA National Drug Code directory (United States)

Active substance: Isosorbide Dinitrate
Manufacturer: Cardinal Health 107, LLC
Country: United States (US)
ATC code: C05AE02
ATC class: Isosorbide dinitrate
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: September 12, 2026

Packs & prices · 1

ndc11
5515479910
10 BLISTER PACK in 1 BAG (55154-7991-0) / 1 TABLET in 1 BLISTER PACK

Regulatory notes

UNII (FDA substance ID)

IA7306519N

ISOSORBIDE DINITRATE

RxCUI 6058

Orange Book

A088088

ABABAB

DailyMed SPL labels

1 version tracked

Same medicine, other countries

Isosorbide dinitrate in 11 other countries

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

All isosorbide dinitrate products

Authorised across Europe · EMA

The same active substance is authorised in 20 EEA countries. Names it is sold under:

Belgium · Cedocard, Cedocard I.V.
Bulgaria · Изодинит
Cyprus · Isorem
Czechia · Cardiket Retard, Isoket
Germany · Isoket, Isoket Lösung
Denmark · Cardopax Retard
Finland · Dinit, Nitrosid
France · Isocard, Isosorbide Medisol
United Kingdom (Northern Ireland) · Isoket, Isoket Retard
Greece · Pensordil
Ireland · Isoket
Italy · Carvasin, Diniket
Lithuania · Cardiket Retard, Isoket
Luxembourg · Cedocard
Latvia · Cardiket Retard, Isoket
Malta · Isitri, Isorem
Netherlands · Isordil, Isordil Titradose
Portugal · Dinitrato De Isossorbida Ip Pls, Dinitrato De Isossorbida Pls
Romania · Isosorbid Dinitrat Arena, Isosorbid Dinitrat Eipico
Slovakia · Cardiket Retard, Isoket

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/712e0a09-ac52-4d38-8f1f-c541e8f6086a
GET /v1/drugs/712e0a09-ac52-4d38-8f1f-c541e8f6086a?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": "IA7306519N",
    "rxcui": "6058",
    "inchikey": "MOYKHGMNXAOIAT-JGWLITMVSA-N",
    "display_name": "ISOSORBIDE DINITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c": {
      "match": "brand_token",
      "title": "ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]",
      "spl_version": "13",
      "published_date": "2026-05-13"
    }
  },
  "productid": "55154-7991_dde61426-7d3b-40a3-9fd4-f654bfb75693",
  "productndc": "55154-7991",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "088088",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Nov 2, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Oct 29, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Oct 29, 1987"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISOSORBIDE DINITRATE",
  "proprietary_name": "Isosorbide Dinitrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA088088",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isosorbide Dinitrate",
  "start_marketing_date": "19830426",
  "active_numerator_strength": "20"
}

API reference MCP server Plans

See everything about isosorbide dinitrate.

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.

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