Isosorbide dinitrate

Orange BookUNIISPLATC C05AE02

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

Identification

ManufacturerNorthstar Rx LLC

CountryUS (United States)

ATC codeC05AE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1671401001
100 TABLET in 1 BOTTLE (16714-010-01)

Annotations

UNII (FDA Substance ID)

IA7306519N

ISOSORBIDE DINITRATE

RxCUI 6058

Orange Book

A213057

ABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "IA7306519N",
    "rxcui": "6058",
    "inchikey": "MOYKHGMNXAOIAT-JGWLITMVSA-N",
    "display_name": "ISOSORBIDE DINITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "16714-010_be0de7ff-f8d9-472f-a35c-252a2cf16954",
  "productndc": "16714-010",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213057",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 20, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Nov 20, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Nov 20, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Nov 20, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "005",
        "approval_date": "Nov 20, 2019"
      }
    ],
    "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": "ANDA213057",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isosorbide dinitrate",
  "start_marketing_date": "20200501",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code C05AE02.

Access this data programmatically

Query Isosorbide dinitrate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs