WELIREG (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 40 mg Bottle Label

NDC 0006-5331-01

WeliregTM
(belzutifan) tablets

40 mg

Dispense the accompanying Medication Guide to each patient.

Each tablet contains 40 mg of belzutifan.

Rx only

90 Tablets

PRINCIPAL DISPLAY PANEL -- 40 mg Bottle Label
(click image for full-size original)
WELIREG belzutifan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-5331
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BELZUTIFAN (BELZUTIFAN) BELZUTIFAN 40 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
FD&C BLUE NO. 2–ALUMINUM LAKE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape OVAL Size 13mm
Flavor Imprint Code 177
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-5331-01 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA215383 08/13/2021
Labeler — Merck Sharp & Dohme Corp. (001317601)

Revised: 08/2021 Merck Sharp & Dohme Corp.

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