Home NDC 0469-2760 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216578-001 VEOZAH FEZOLINETANT 45MG TABLET / ORAL RLD, RS 2023-05-12
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216578-001 8871761 2031-04-04 Drug substance 2023-06-06 N216578-001 10836768 2034-03-28 U-3622 2023-06-06 N216578-001 9422299 2034-03-28 U-3622 Drug substance, Drug product 2023-06-06 N216578-001 9987274 2034-03-28 U-3622 2023-06-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216578-001 NCE 2028-05-12
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216578-001 VEOZAH 45MG TABLET / ORAL RLD, RS 2023-05-12 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N216578-001 8871761 2031-04-04 Drug substance 2023-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216578-001 10836768 2034-03-28 U-3622 2023-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216578-001 9422299 2034-03-28 U-3622 Drug substance, Drug product 2023-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216578-001 9987274 2034-03-28 U-3622 2023-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216578-001 8871761 2031-04-04 Drug substance 2023-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216578-001 10836768 2034-03-28 U-3622 2023-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216578-001 9422299 2034-03-28 U-3622 Drug substance, Drug product 2023-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216578-001 9987274 2034-03-28 U-3622 2023-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216578-001 8871761 2031-04-04 Drug substance 2023-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216578-001 10836768 2034-03-28 U-3621 2023-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216578-001 9422299 2034-03-28 U-3622 Drug substance, Drug product 2023-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216578-001 9987274 2034-03-28 U-3622 2023-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216578-001 8871761 2031-04-04 Drug substance 2023-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216578-001 10836768 2034-03-28 U-3621 2023-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216578-001 9422299 2034-03-28 U-3622 Drug substance, Drug product 2023-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216578-001 9987274 2034-03-28 U-3622 2023-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216578-001 8871761 2031-04-04 Drug substance 2023-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216578-001 10836768 2034-03-28 U-3621 2023-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216578-001 9422299 2034-03-28 U-3622 Drug substance, Drug product 2023-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216578-001 9987274 2034-03-28 U-3622 2023-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216578-001 8871761 2031-04-04 Drug substance 2023-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216578-001 10836768 2034-03-28 U-3621 2023-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216578-001 9422299 2034-03-28 U-3622 Drug substance, Drug product 2023-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216578-001 9987274 2034-03-28 U-3622 2023-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216578-001 8871761 2031-04-04 Drug substance 2023-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216578-001 10836768 2034-03-28 U-3621 2023-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216578-001 9422299 2034-03-28 U-3622 Drug substance, Drug product 2023-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216578-001 9987274 2034-03-28 U-3622 2023-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216578-001 8871761 2031-04-04 Drug substance 2023-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216578-001 10836768 2034-03-28 U-3621 2023-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216578-001 9422299 2034-03-28 U-3622 Drug substance, Drug product 2023-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216578-001 9987274 2034-03-28 U-3622 2023-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216578-001 8871761 2031-04-04 Drug substance 2023-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216578-001 10836768 2034-03-28 U-3621 2023-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216578-001 9422299 2034-03-28 U-3622 Drug substance, Drug product 2023-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216578-001 9987274 2034-03-28 U-3622 2023-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216578-001 8871761 2031-04-04 Drug substance 2023-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216578-001 10836768 2034-03-28 U-3621 2023-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216578-001 9422299 2034-03-28 U-3622 Drug substance, Drug product 2023-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216578-001 9987274 2034-03-28 U-3622 2023-06-06 d06236e962d9…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base VEOZAH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEZOLINETANT 45 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 83VNE45KXX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2637141 Internal RxNorm lookup 2637147 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0469-2760-07 VEOZAH 7 in 1 BLISTER PACK TABLET, FILM COATED 7 8 0469-2760-07 VEOZAH 1 in 1 CARTON TABLET, FILM COATED 1 8 0469-2760-28 VEOZAH 4 in 1 TRAY TABLET, FILM COATED 4 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0469-2760 VEOZAH (FEZOLINETANT) TABLET, FILM COATED [ASTELLAS PHARMA US, INC.] 7 Current NDC, 3 package rows 20250101_cae9f798-24f9-4580-a4fc-e6c710cbda3c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VEOZAH FEZOLINETANT Astellas Pharma US, Inc. cae9f798-24f9-4580-a4fc-e6c710cbda3c 2026-02-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 216578 application number: NDA216578 ndc (product): 0469-2760
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0469-2760-07 00469276007 7 in 1 BLISTER PACK Historical 0469-2760-28 00469276028 4 CARTON in 1 TRAY (0469-2760-28) / 1 BLISTER PACK in 1 CARTON (0469-2760-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK 4 carton 2023-05-12 Yes No Current