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
7133525321
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-1)
ndc11
7133525322
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-2)
ndc11
7133525323
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-3)
ndc11
7133525324
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-4)
ndc11
7133525325
10 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-5)

Annotations

UNII (FDA Substance ID)

LX1OH63030

ISOSORBIDE MONONITRATE

RxCUI 28004

Orange Book

A075522

ABAB

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": "71335-2532_334cb4f5-b33c-4871-9777-7bd9d0f4cab0",
  "productndc": "71335-2532",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "075522",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Apr 17, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Sep 20, 2016"
      }
    ],
    "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": "ANDA075522",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isosorbide Mononitrate",
  "start_marketing_date": "20100607",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code C01DA14.

Access this data programmatically

Query Isosorbide Mononitrate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs