FDA.reportPublic FDA data

WELIREG

Product NDC
0006-5331
11-digit product format
000065331
Labeler code
0006
Product ID
0006-5331_114cd6ad-9203-4034-b390-3e0901e064a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
belzutifan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA215383
Marketing category
NDA
Marketing start
2021-08-13
Substance
BELZUTIFAN
Active strength
40 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inducers [MoA], Hypoxia-inducible Factor 2 alpha Inhibitors [MoA], Hypoxia-inducible Factor Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
WELIREG
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BELZUTIFAN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7K28NB895L
Rxcui2567231, 2567237

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9187f2c5-6cdd-4cb8-ba1c-ad3b7d5c64caProduct name120220217
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-5331-01WELIREG90 in 1 BOTTLETABLET, FILM COATED9011
0006-5331-58WELIREG90 in 1 BOTTLETABLET, FILM COATED9011
0006-5331-58WELIREG1 in 1 CARTONTABLET, FILM COATED111
0006-5331-59WELIREG1 in 1 CARTONTABLET, FILM COATED111
0006-5331-59WELIREG90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-5331-01EA - Each0006-533130040d84-f05a-4584-a049-6d4d9729f08112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-5331WELIREG (BELZUTIFAN) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]11Current NDC, Legacy NDC, 5 package rows20250523_13e15ee0-d679-4fa9-9430-e2e2170474da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2567231belzutifan 40 MG Oral TabletPSN13e15ee0-d679-4fa9-9430-e2e2170474da11
2567237Welireg 40 MG Oral TabletPSN13e15ee0-d679-4fa9-9430-e2e2170474da11
2567237belzutifan 40 MG Oral Tablet [Welireg]SBD13e15ee0-d679-4fa9-9430-e2e2170474da11
2567231belzutifan 40 MG Oral TabletSCD13e15ee0-d679-4fa9-9430-e2e2170474da11
2567237Welireg 40 MG Oral TabletSY13e15ee0-d679-4fa9-9430-e2e2170474da11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-5331-010000653310190 TABLET, FILM COATED in 1 BOTTLE (0006-5331-01) 2021-08-130000-00-00NoNoCurrent
0006-5331-58000065331581 BOTTLE in 1 CARTON (0006-5331-58) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-06-21YesNoHistorical
0006-5331-59000065331591 BOTTLE in 1 CARTON (0006-5331-59) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-06-21YesNoHistorical