Isosorbide Mononitrate

Orange BookUNIISPLATC C01DA14

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC01DA14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7133521921
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-1)
ndc11
7133521922
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-2)
ndc11
7133521923
60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-3)
ndc11
7133521924
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-4)
ndc11
7133521925
10 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-5)

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": "71335-2192_79752f3a-c401-46d7-84a5-9383a04c792d",
  "productndc": "71335-2192",
  "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": "20181113",
  "active_numerator_strength": "60"
}

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