welireg

Generic: belzutifan

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name welireg
Generic Name belzutifan
Labeler merck sharp & dohme llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

belzutifan 40 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-5331
Product ID 0006-5331_114cd6ad-9203-4034-b390-3e0901e064a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215383
Listing Expiration 2026-12-31
Marketing Start 2021-08-13

Pharmacologic Class

Established (EPC)
hypoxia-inducible factor inhibitor [epc]
Mechanism of Action
hypoxia-inducible factor 2 alpha inhibitors [moa] cytochrome p450 3a4 inducers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00065331
Hyphenated Format 0006-5331

Supplemental Identifiers

RxCUI
2567231 2567237
UPC
0300065331010
UNII
7K28NB895L
NUI
N0000193999 N0000193998 N0000185506

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name welireg (source: ndc)
Generic Name belzutifan (source: ndc)
Application Number NDA215383 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (0006-5331-01)
  • 1 BOTTLE in 1 CARTON (0006-5331-58) / 90 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0006-5331-59) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

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

Ingredients (1)

belzutifan (40 mg/1)

Linked Drug Pages (1)

WELIREG ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "114cd6ad-9203-4034-b390-3e0901e064a4", "openfda": {"nui": ["N0000193999", "N0000193998", "N0000185506"], "upc": ["0300065331010"], "unii": ["7K28NB895L"], "rxcui": ["2567231", "2567237"], "spl_set_id": ["13e15ee0-d679-4fa9-9430-e2e2170474da"], "pharm_class_epc": ["Hypoxia-inducible Factor Inhibitor [EPC]"], "pharm_class_moa": ["Hypoxia-inducible Factor 2 alpha Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0006-5331-01)", "package_ndc": "0006-5331-01", "marketing_start_date": "20210813"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (0006-5331-58)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0006-5331-58", "marketing_start_date": "20230621"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (0006-5331-59)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0006-5331-59", "marketing_start_date": "20230621"}], "brand_name": "WELIREG", "product_id": "0006-5331_114cd6ad-9203-4034-b390-3e0901e064a4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A4 Inducers [MoA]", "Hypoxia-inducible Factor 2 alpha Inhibitors [MoA]", "Hypoxia-inducible Factor Inhibitor [EPC]"], "product_ndc": "0006-5331", "generic_name": "belzutifan", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "WELIREG", "active_ingredients": [{"name": "BELZUTIFAN", "strength": "40 mg/1"}], "application_number": "NDA215383", "marketing_category": "NDA", "marketing_start_date": "20210813", "listing_expiration_date": "20261231"}