Isosorbide Mononitrate

Orange BookUNIISPLATC C01DA14

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeC01DA14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7161078830
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-788-30)
ndc11
7161078860
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-788-60)

Annotations

UNII (FDA Substance ID)

LX1OH63030

ISOSORBIDE MONONITRATE

RxCUI 28004

Orange Book

A210918

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "LX1OH63030",
    "rxcui": "28004",
    "inchikey": "YWXYYJSYQOXTPL-SLPGGIOYSA-N",
    "display_name": "ISOSORBIDE MONONITRATE",
    "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": "71610-788_ed4b9b65-54be-40f0-b2d0-452b7d1b49c4",
  "productndc": "71610-788",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210918",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Nov 5, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Nov 5, 2018"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "003",
        "approval_date": "Nov 5, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISOSORBIDE MONONITRATE",
  "proprietary_name": "Isosorbide Mononitrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210918",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isosorbide Mononitrate",
  "start_marketing_date": "20181105",
  "active_numerator_strength": "30"
}

Related drugs

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