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United States · US · US:68682-193_723d9f78-9d77-4575-af27-1aa117e6b8d7

Isosorbide Dinitrate

Orange BookUNIISPLATC C05AE02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeC05AE02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6868219301
    100 TABLET in 1 BOTTLE (68682-193-01)

Annotations

UNII (FDA Substance ID)
IA7306519N
ISOSORBIDE DINITRATE
RxCUI 6058
Orange Book
N012093
ABAB
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": "68682-193_723d9f78-9d77-4575-af27-1aa117e6b8d7",
  "productndc": "68682-193",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "012093",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Jul 29, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Jul 29, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Jul 29, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Jul 29, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "007",
        "approval_date": "Jul 29, 1988"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISOSORBIDE DINITRATE",
  "proprietary_name": "Isosorbide Dinitrate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA012093",
  "marketing_category": "NDA",
  "nonproprietary_name": "isosorbide dinitrate",
  "start_marketing_date": "20200302",
  "active_numerator_strength": "5"
}

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