Home NDC 0469-1125 Xtandi
Product NDC 0469-1125
11-digit product format 004691125
Labeler code 0469
Product ID 0469-1125_cfc2fbc2-2657-407f-b0f0-bd41fb98d89e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name enzalutamide
Dosage form CAPSULE
Route ORAL
Labeler Astellas Pharma US, Inc.
Application NDA203415
Marketing category NDA
Marketing start 2012-08-31
Substance ENZALUTAMIDE
Active strength 40 mg/1
Pharmacologic classes Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 N203415-001 XTANDI ENZALUTAMIDE 40MG CAPSULE / ORAL RLD, RS 2012-08-31
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N203415-001 I-926 2026-11-17
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.
Product history page 1 of 2 · 41 observed 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 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203415-001 XTANDI 40MG CAPSULE / ORAL AB RLD, RS 2012-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203415-001 XTANDI 40MG CAPSULE / ORAL AB RLD, RS 2012-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203415-001 XTANDI 40MG CAPSULE / ORAL AB RLD, RS 2012-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203415-001 XTANDI 40MG CAPSULE / ORAL AB RLD, RS 2012-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203415-001 XTANDI 40MG CAPSULE / ORAL AB RLD, RS 2012-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203415-001 XTANDI 40MG CAPSULE / ORAL AB RLD, RS 2012-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203415-001 XTANDI 40MG CAPSULE / ORAL AB RLD, RS 2012-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203415-001 XTANDI 40MG CAPSULE / ORAL AB RLD, RS 2012-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203415-001 XTANDI 40MG CAPSULE / ORAL RLD, RS 2012-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203415-001 XTANDI 40MG CAPSULE / ORAL AB RLD, RS 2012-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203415-001 XTANDI 40MG CAPSULE / ORAL AB RLD, RS 2012-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203415-001 XTANDI 40MG CAPSULE / ORAL AB RLD, RS 2012-08-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203415-001 XTANDI 40MG CAPSULE / ORAL AB RLD, RS 2012-08-31 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 10 · 378 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 N203415-001 9126941 2026-05-15 U-2345 2015-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 9126941 2026-05-15 U-1588 2015-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 9126941 2026-05-15 U-2708 2015-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 9126941 2026-05-15 U-3763 2015-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 8183274 2026-08-24 U-1281 2012-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 8183274 2026-08-24 U-1588 2012-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 8183274 2026-08-24 U-2708 2012-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 8183274 2026-08-24 U-2345 2012-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 8183274 2026-08-24 U-3763 2012-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 7709517 2027-08-13 Drug substance, Drug product 2012-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 12161628 2037-02-23 U-4101 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 12161628 2037-02-23 U-4102 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 12161628 2037-02-23 U-4103 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203415-001 12161628 2037-02-23 U-4104 2025-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 9126941 2026-05-15 U-2345 2015-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 9126941 2026-05-15 U-1588 2015-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 9126941 2026-05-15 U-2708 2015-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 9126941 2026-05-15 U-3763 2015-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 8183274 2026-08-24 U-1281 2012-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 8183274 2026-08-24 U-1588 2012-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 8183274 2026-08-24 U-2708 2012-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 8183274 2026-08-24 U-2345 2012-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 8183274 2026-08-24 U-3763 2012-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 7709517 2027-08-13 Drug substance, Drug product 2012-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 12161628 2037-02-23 U-4101 2025-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 12161628 2037-02-23 U-4102 2025-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 12161628 2037-02-23 U-4103 2025-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203415-001 12161628 2037-02-23 U-4104 2025-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203415-001 9126941 2026-05-15 U-2345 2015-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203415-001 9126941 2026-05-15 U-1588 2015-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203415-001 9126941 2026-05-15 U-2708 2015-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203415-001 9126941 2026-05-15 U-3763 2015-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203415-001 8183274 2026-08-24 U-1281 2012-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203415-001 8183274 2026-08-24 U-1588 2012-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203415-001 8183274 2026-08-24 U-2708 2012-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203415-001 8183274 2026-08-24 U-2345 2012-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203415-001 8183274 2026-08-24 U-3763 2012-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203415-001 7709517 2027-08-13 Drug substance, Drug product 2012-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203415-001 12161628 2037-02-23 U-4101 2025-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203415-001 12161628 2037-02-23 U-4102 2025-01-08 6a471c1ec25d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Xtandi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENZALUTAMIDE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 93T0T9GKNU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1307303 Internal RxNorm lookup 1307309 Internal RxNorm lookup 2390644 Internal RxNorm lookup 2390646 Internal RxNorm lookup 2390648 Internal RxNorm lookup 2390650 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 0469-1125-56 Xtandi 56 in 1 BLISTER PACK CAPSULE 56 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0469-1125 XTANDI (ENZALUTAMIDE) CAPSULE XTANDI (ENZALUTAMIDE) TABLET [ASTELLAS PHARMA US, INC.] 21 Current NDC, Legacy NDC, 1 package rows 20250406_b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0469-1125-56 00469112556 56 CAPSULE in 1 BLISTER PACK (0469-1125-56) 56 capsule 2012-08-31 0000-00-00 Yes No Current