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United States · US · US:0597-7313_86fd1ab2-c0a5-4ab7-8ae7-da8b42c169ca

JASCAYD

Orange BookUNIISPLATC L04AA

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

Identification

ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL04AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0597731321
    1 BOTTLE, PLASTIC in 1 CARTON (0597-7313-21) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
I5DGT51IB8
NERANDOMILAST
Orange Book
N218764
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "I5DGT51IB8",
    "rxcui": null,
    "inchikey": "UHYCLWAANUGUMN-SSEXGKCCSA-N",
    "display_name": "NERANDOMILAST",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "fa1b14c6-957f-d326-5099-911bfe33e391": {
      "match": "brand_token",
      "title": "JASCAYD (NERANDOMILAST) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
      "spl_version": "4",
      "published_date": "2026-02-06"
    }
  },
  "productid": "0597-7313_86fd1ab2-c0a5-4ab7-8ae7-da8b42c169ca",
  "productndc": "0597-7313",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218764",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "9MG",
        "product_no": "001",
        "approval_date": "Oct 7, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "18MG",
        "product_no": "002",
        "approval_date": "Oct 7, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NERANDOMILAST",
  "proprietary_name": "JASCAYD",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218764",
  "marketing_category": "NDA",
  "nonproprietary_name": "nerandomilast",
  "start_marketing_date": "20251007",
  "active_numerator_strength": "18"
}

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