VEOZAH

Product NDC
0469-2760
11-digit product format
004692760
Labeler code
0469
Product ID
0469-2760_462f0a23-98d6-4154-b113-322008069743
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fezolinetant
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Astellas Pharma US, Inc.
Application
NDA216578
Marketing category
NDA
Marketing start
2023-05-12
Substance
FEZOLINETANT
Active strength
45 mg/1
Pharmacologic classes
Neurokinin 3 Receptor Antagonist [EPC], Neurokinin 3 Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VEOZAH
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEZOLINETANT45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83VNE45KXX
Rxcui2637141, 2637147

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f992a785-fa79-488d-ab33-b522097c9773Product name120231011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0469-2760-07VEOZAH7 in 1 BLISTER PACKTABLET, FILM COATED78
0469-2760-07VEOZAH1 in 1 CARTONTABLET, FILM COATED18
0469-2760-28VEOZAH4 in 1 TRAYTABLET, FILM COATED48

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0469-2760VEOZAH (FEZOLINETANT) TABLET, FILM COATED [ASTELLAS PHARMA US, INC.]7Current NDC, 3 package rows20250101_cae9f798-24f9-4580-a4fc-e6c710cbda3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637141fezolinetant 45 MG Oral TabletPSNcae9f798-24f9-4580-a4fc-e6c710cbda3c8
2637147VEOZAH 45 MG Oral TabletPSNcae9f798-24f9-4580-a4fc-e6c710cbda3c8
2637147fezolinetant 45 MG Oral Tablet [Veozah]SBDcae9f798-24f9-4580-a4fc-e6c710cbda3c8
2637141fezolinetant 45 MG Oral TabletSCDcae9f798-24f9-4580-a4fc-e6c710cbda3c8
2637147Veozah 45 MG Oral TabletSYcae9f798-24f9-4580-a4fc-e6c710cbda3c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0469-2760-07004692760077 in 1 BLISTER PACKHistorical
0469-2760-28004692760284 CARTON in 1 TRAY (0469-2760-28) / 1 BLISTER PACK in 1 CARTON (0469-2760-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK4 carton2023-05-12YesNoCurrent