Isosorbide dinitrate

Orange BookUNIISPLATC C05AE02

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

Identification

ManufacturerBluePoint Laboratories

CountryUS (United States)

ATC codeC05AE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6800156200
100 TABLET in 1 BOTTLE (68001-562-00)

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": "68001-562_224fb831-928b-b275-e063-6394a90ab649",
  "productndc": "68001-562",
  "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": "20230805",
  "active_numerator_strength": "30"
}

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