VEOZAH (Page 5 of 5)

Package/Label Display Panel – VEOZAH Bottle Carton Label

NDC 0469-2660-30
Rx Only

VEOZAH^™
(fezolinetant) tablets45 mg

30 tablets

Package/Label Display Panel – VEOZAH Sample Bottle Carton Label

NDC 0469-2460-07

PROFESSIONAL SAMPLE-NOT FOR SALE

Rx Only

VEOZAH^™
(fezolinetant) tablets45 mg

7 tablets

Package/Label Display Panel- VEOZAH Sample Blister Carton Label

NDC 0469-2760-07

PROFESSIONAL SAMPLE-NOT FOR SALE

Rx Only

VEOZAH^™
(fezolinetant) tablets45 mg

7 tablets

VEOZAH fezolinetant tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0469-2660 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEZOLINETANT (FEZOLINETANT) FEZOLINETANT 45 mg

Inactive Ingredients Ingredient Name Strength MANNITOL HYDROXYPROPYL CELLULOSE, UNSPECIFIED LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) TALC POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE FERRIC OXIDE RED

Product Characteristics Color RED (LIGHT RED) Score no score Shape ROUND Size 7mm Flavor Imprint Code Astellas;logo;645 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0469-2660-30 1 BOTTLE in 1 CARTON contains a BOTTLE 1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (0469-2660-30) 2 NDC:0469-2660-90 1 BOTTLE in 1 CARTON contains a BOTTLE 2 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (0469-2660-90)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA216578 05/12/2023

VEOZAH fezolinetant tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0469-2460 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEZOLINETANT (FEZOLINETANT) FEZOLINETANT 45 mg

Inactive Ingredients Ingredient Name Strength MANNITOL HYDROXYPROPYL CELLULOSE, UNSPECIFIED LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) TALC POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE FERRIC OXIDE RED

Product Characteristics Color RED (LIGHT RED) Score no score Shape ROUND Size 7mm Flavor Imprint Code Astellas;logo;645 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0469-2460-28 4 CARTON in 1 TRAY contains a CARTON (0469-2460-07) 1 NDC:0469-2460-07 1 BOTTLE in 1 CARTON This package is contained within the TRAY (0469-2460-28) and contains a BOTTLE 1 7 TABLET, FILM COATED in 1 BOTTLE This package is contained within a CARTON (0469-2460-07) and a TRAY (0469-2460-28)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA216578 05/16/2023

VEOZAH fezolinetant tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0469-2760 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEZOLINETANT (FEZOLINETANT) FEZOLINETANT 45 mg

Inactive Ingredients Ingredient Name Strength MANNITOL HYDROXYPROPYL CELLULOSE, UNSPECIFIED LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) TALC POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE FERRIC OXIDE RED

Product Characteristics Color RED (LIGHT RED) Score no score Shape ROUND Size 7mm Flavor Imprint Code Astellas;logo;645 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0469-2760-28 4 CARTON in 1 TRAY contains a CARTON (0469-2760-07) 1 NDC:0469-2760-07 1 BLISTER PACK in 1 CARTON This package is contained within the TRAY (0469-2760-28) and contains a BLISTER PACK 1 7 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within a CARTON (0469-2760-07) and a TRAY (0469-2760-28)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA216578 05/12/2023

Labeler — Astellas Pharma US, Inc. (605764828)

Registrant — Astellas Pharma US, Inc. (605764828)

Establishment
Name	Address	ID/FEI	Operations
AndersonBrecon Inc.		053217022	LABEL (0469-2660), LABEL (0469-2460), LABEL (0469-2760), PACK (0469-2660), PACK (0469-2460), PACK (0469-2760)

Establishment
Name	Address	ID/FEI	Operations
Fujimoto Chemicals Co., Ltd.		717836709	API MANUFACTURE (0469-2660), API MANUFACTURE (0469-2460), API MANUFACTURE (0469-2760)

Establishment
Name	Address	ID/FEI	Operations
Juzen Chemical Corporation		691036974	API MANUFACTURE (0469-2660), API MANUFACTURE (0469-2460), API MANUFACTURE (0469-2760), ANALYSIS (0469-2660), ANALYSIS (0469-2460), ANALYSIS (0469-2760)

Establishment
Name	Address	ID/FEI	Operations
Astellas Pharma Inc.		695086702	MANUFACTURE (0469-2660), MANUFACTURE (0469-2460), MANUFACTURE (0469-2760), ANALYSIS (0469-2660), ANALYSIS (0469-2460), ANALYSIS (0469-2760)

Revised: 05/2023 Astellas Pharma US, Inc.