Home NDC 0469-0725 Xtandi
Product NDC 0469-0725
11-digit product format 004690725
Labeler code 0469
Product ID 0469-0725_cfc2fbc2-2657-407f-b0f0-bd41fb98d89e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name enzalutamide
Dosage form TABLET
Route ORAL
Labeler Astellas Pharma US, Inc.
Application NDA213674
Marketing category NDA
Marketing start 2020-08-04
Substance ENZALUTAMIDE
Active strength 80 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213674-001 XTANDI ENZALUTAMIDE 40MG TABLET / ORAL AB RLD 2020-08-04 N213674-002 XTANDI ENZALUTAMIDE 80MG TABLET / ORAL AB RLD, RS 2020-08-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 33 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213674-001 I-926 2026-11-17 N213674-002 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 · 74 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 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 87673890dc5c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213674-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213674-002 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 14 · 541 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 N213674-001 9126941 2026-05-15 U-2708 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 9126941 2026-05-15 U-2345 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 9126941 2026-05-15 U-3763 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 8183274 2026-08-24 U-2345 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 8183274 2026-08-24 U-2708 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 8183274 2026-08-24 U-3763 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 7709517 2027-08-13 Drug substance, Drug product 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 11839689 2033-09-11 Drug product 2023-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12502357 2033-09-11 U-4363 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12502357 2033-09-11 U-4364 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12502357 2033-09-11 U-4365 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12161628 2037-02-23 U-4101 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12161628 2037-02-23 U-4102 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12161628 2037-02-23 U-4103 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12161628 2037-02-23 U-4104 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 9126941 2026-05-15 U-2708 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 9126941 2026-05-15 U-2345 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 9126941 2026-05-15 U-3763 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 8183274 2026-08-24 U-2708 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 8183274 2026-08-24 U-2345 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 8183274 2026-08-24 U-3763 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 7709517 2027-08-13 Drug substance, Drug product 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 11839689 2033-09-11 Drug product 2023-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12447128 2033-09-11 U-4312 2025-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12447128 2033-09-11 U-4313 2025-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12447128 2033-09-11 U-4314 2025-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12502357 2033-09-11 U-4363 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12502357 2033-09-11 U-4364 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12502357 2033-09-11 U-4365 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12161628 2037-02-23 U-4102 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12161628 2037-02-23 U-4103 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12161628 2037-02-23 U-4104 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12161628 2037-02-23 U-4101 2025-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 9126941 2026-05-15 U-2708 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 9126941 2026-05-15 U-2345 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 9126941 2026-05-15 U-3763 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 8183274 2026-08-24 U-2345 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 8183274 2026-08-24 U-2708 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 8183274 2026-08-24 U-3763 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 7709517 2027-08-13 Drug substance, Drug product 2020-09-03 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 68 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Xtandi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENZALUTAMIDE 80 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 0469-0725-60 Xtandi 60 in 1 BOTTLE TABLET 60 22 0469-0725-60 Xtandi 1 in 1 CARTON TABLET 1 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0469-0725 XTANDI (ENZALUTAMIDE) CAPSULE XTANDI (ENZALUTAMIDE) TABLET [ASTELLAS PHARMA US, INC.] 21 Current NDC, Legacy NDC, 2 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 0469-0725-60 00469072560 1 BOTTLE in 1 CARTON (0469-0725-60) / 60 TABLET in 1 BOTTLE 1 bottle 2020-08-04 0000-00-00 No No Current