ISOSORBIDE MONONITRATE

Orange BookUNIISPLATC C01DA14

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

Identification

ManufacturerCoupler LLC

CountryUS (United States)

ATC codeC01DA14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6704614463
30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1446-3)

Annotations

UNII (FDA Substance ID)

LX1OH63030

ISOSORBIDE MONONITRATE

RxCUI 28004

Orange Book

A216557

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": "67046-1446_2d9988ef-55cb-3043-e063-6294a90a1851",
  "productndc": "67046-1446",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "216557",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Nov 7, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Nov 7, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "003",
        "approval_date": "Nov 7, 2022"
      }
    ],
    "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": "ANDA216557",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ISOSORBIDE MONONITRATE",
  "start_marketing_date": "20250207",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code C01DA14.

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