Jesduvroq

Orange BookUNIISPLATC B03XA07

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

Identification

ManufacturerGlaxoSmithKline LLC

CountryUS (United States)

ATC codeB03XA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0173091113
30 TABLET, FILM COATED in 1 BOTTLE (0173-0911-13)

Annotations

UNII (FDA Substance ID)

JVR38ZM64B

DAPRODUSTAT

Orange Book

N216951

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "JVR38ZM64B",
    "rxcui": null,
    "inchikey": "RUEYEZADQJCKGV-UHFFFAOYSA-N",
    "display_name": "DAPRODUSTAT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d82aa06e-5a33-4844-99b7-4701313455a4": {
      "match": "brand_token",
      "title": "JESDUVROQ (DAPRODUSTAT) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]",
      "spl_version": "5",
      "published_date": "2025-03-17"
    }
  },
  "productid": "0173-0911_d52a823a-35bd-4c6a-a016-4b4f21a43d7d",
  "productndc": "0173-0911",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216951",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Feb 1, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Feb 1, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "4MG",
        "product_no": "003",
        "approval_date": "Feb 1, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "6MG",
        "product_no": "004",
        "approval_date": "Feb 1, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "8MG",
        "product_no": "005",
        "approval_date": "Feb 1, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAPRODUSTAT",
  "proprietary_name": "Jesduvroq",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216951",
  "marketing_category": "NDA",
  "nonproprietary_name": "daprodustat",
  "start_marketing_date": "20230201",
  "active_numerator_strength": "6"
}

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