WELIREG

Orange BookUNIISPLATC L01XX74

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

Identification

ManufacturerMerck Sharp & Dohme LLC

CountryUS (United States)

ATC codeL01XX74

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0006533101
90 TABLET, FILM COATED in 1 BOTTLE (0006-5331-01)
ndc11
0006533158
1 BOTTLE in 1 CARTON (0006-5331-58) / 90 TABLET, FILM COATED in 1 BOTTLE
ndc11
0006533159
1 BOTTLE in 1 CARTON (0006-5331-59) / 90 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

7K28NB895L

BELZUTIFAN

RxCUI 2567226

Orange Book

N215383

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "7K28NB895L",
    "rxcui": "2567226",
    "inchikey": "LOMMPXLFBTZENJ-ZACQAIPSSA-N",
    "display_name": "BELZUTIFAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "13e15ee0-d679-4fa9-9430-e2e2170474da": {
      "match": "brand_token",
      "title": "WELIREG (BELZUTIFAN) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]",
      "spl_version": "11",
      "published_date": "2025-05-23"
    }
  },
  "productid": "0006-5331_114cd6ad-9203-4034-b390-3e0901e064a4",
  "productndc": "0006-5331",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215383",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Aug 13, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BELZUTIFAN",
  "proprietary_name": "WELIREG",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215383",
  "marketing_category": "NDA",
  "nonproprietary_name": "belzutifan",
  "start_marketing_date": "20210813",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code L01XX74.

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