Rezurock

Orange BookUNIISPLATC L04AA48

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

Identification

ManufacturerKadmon Pharmaceuticals, LLC

CountryUS (United States)

ATC codeL04AA48

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7980220030
1 BOTTLE in 1 CARTON (79802-200-30) / 30 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

834YJF89WO

BELUMOSUDIL

RxCUI 2564025

Orange Book

N214783

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "834YJF89WO",
    "rxcui": "2564025",
    "inchikey": "GKHIVNAUVKXIIY-UHFFFAOYSA-N",
    "display_name": "BELUMOSUDIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "102e4ef4-7f84-4e34-8df1-479c24d1575d": {
      "match": "brand_token",
      "title": "REZUROCK (BELUMOSUDIL) TABLET [KADMON PHARMACEUTICALS, LLC]",
      "spl_version": "11",
      "published_date": "2026-04-09"
    }
  },
  "productid": "79802-200_65249371-3fc5-4a85-a999-9ed367b8dd73",
  "productndc": "79802-200",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214783",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "Jul 16, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BELUMOSUDIL",
  "proprietary_name": "Rezurock",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214783",
  "marketing_category": "NDA",
  "nonproprietary_name": "belumosudil",
  "start_marketing_date": "20210716",
  "active_numerator_strength": "200"
}

Related drugs

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