veozah

Generic: fezolinetant

Labeler: astellas pharma us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name veozah
Generic Name fezolinetant
Labeler astellas pharma us, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fezolinetant 45 mg/1

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 0469-2460
Product ID 0469-2460_794637d8-62d5-49d4-90e8-bb01c073514a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216578
Listing Expiration 2026-12-31
Marketing Start 2023-05-16

Pharmacologic Class

Established (EPC)
neurokinin 3 receptor antagonist [epc]
Mechanism of Action
neurokinin 3 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04692460
Hyphenated Format 0469-2460

Supplemental Identifiers

RxCUI
2637141 2637147
UNII
83VNE45KXX
NUI
N0000194090 N0000194091

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name veozah (source: ndc)
Generic Name fezolinetant (source: ndc)
Application Number NDA216578 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 4 CARTON in 1 TRAY (0469-2460-28) / 1 BOTTLE in 1 CARTON (0469-2460-07) / 7 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

0469-2460-28 4 CARTON in 1 TRAY (0469-2460-28) / 1 BOTTLE in 1 CARTON (0469-2460-07) / 7 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

fezolinetant (45 mg/1)

Linked Drug Pages (1)

VEOZAH ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "794637d8-62d5-49d4-90e8-bb01c073514a", "openfda": {"nui": ["N0000194090", "N0000194091"], "unii": ["83VNE45KXX"], "rxcui": ["2637141", "2637147"], "spl_set_id": ["cae9f798-24f9-4580-a4fc-e6c710cbda3c"], "pharm_class_epc": ["Neurokinin 3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Neurokinin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Astellas Pharma US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "4 CARTON in 1 TRAY (0469-2460-28)  / 1 BOTTLE in 1 CARTON (0469-2460-07)  / 7 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0469-2460-28", "marketing_start_date": "20230516"}], "brand_name": "VEOZAH", "product_id": "0469-2460_794637d8-62d5-49d4-90e8-bb01c073514a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Neurokinin 3 Receptor Antagonist [EPC]", "Neurokinin 3 Receptor Antagonists [MoA]"], "product_ndc": "0469-2460", "generic_name": "fezolinetant", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VEOZAH", "active_ingredients": [{"name": "FEZOLINETANT", "strength": "45 mg/1"}], "application_number": "NDA216578", "marketing_category": "NDA", "marketing_start_date": "20230516", "listing_expiration_date": "20261231"}