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United States · US · US:51407-209_26ab803d-04f8-b766-e063-6394a90a117f

Isosorbide Mononitrate

Orange BookUNIISPLATC C01DA14

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

Identification

ManufacturerGolden State Medical Supply, Inc.
CountryUS (United States)
ATC codeC01DA14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5140720901
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-209-01)
  • ndc11
    5140720905
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-209-05)

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": "51407-209_26ab803d-04f8-b766-e063-6394a90a117f",
  "productndc": "51407-209",
  "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": "60"
}

Related drugs

Other records sharing ATC code C01DA14.

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