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NDC 00006-5331-59 WELIREG 40 mg/1 Details
WELIREG 40 mg/1
WELIREG is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Merck Sharp & Dohme LLC. The primary component is BELZUTIFAN.
MedlinePlus Drug Summary
Belzutifan is used in adults with von Hippel-Lindau disease (VHL; a rare disease that causes tumors and cysts) to treat renal cell carcinoma (RCC; kidney cancer), central nervous system (CNS) hemangioblastomas (tumors in the brain and spinal cord), and a certain type of pancreatic cancer that does not require surgery right away. Belzutifan is also used to treat certain types of RCC in adult patients. Belzutifan is in a class of medications called hypoxia-inducible factor inhibitors. It works by blocking the activity of a certain protein in people with VHL.
Related Packages: 00006-5331-59Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Belzutifan
Product Information
| NDC | 00006-5331 |
|---|---|
| Product ID | 0006-5331_609c65d7-4bcd-4d2d-bad5-63a38cdd1b16 |
| Associated GPIs | 21421020000320 |
| GCN Sequence Number | 082589 |
| GCN Sequence Number Description | belzutifan TABLET 40 MG ORAL |
| HIC3 | V16 |
| HIC3 Description | ANTINEOPLASTIC-HYPOXIA INDUCIBLE FACTOR (HIF) INH |
| GCN | 50046 |
| HICL Sequence Number | 047546 |
| HICL Sequence Number Description | BELZUTIFAN |
| Brand/Generic | Brand |
| Proprietary Name | WELIREG |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | belzutifan |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/1 |
| Substance Name | BELZUTIFAN |
| Labeler Name | Merck Sharp & Dohme LLC |
| Pharmaceutical Class | Cytochrome P450 3A4 Inducers [MoA], Hypoxia-inducible Factor 2 alpha Inhibitors [MoA], Hypoxia-inducible Factor Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA215383 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00006-5331-59 (00006533159)
| NDC Package Code | 0006-5331-59 |
|---|---|
| Billing NDC | 00006533159 |
| Package | 1 BOTTLE in 1 CARTON (0006-5331-59) / 90 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2023-06-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |