Xtandi

Product NDC: 0469-1725
11-digit product format: 004691725
Labeler code: 0469
Product ID: 0469-1725_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: 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 42.

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.

Application-product, TE code table
Application-product	TE code
N213674-001	AB
N213674-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 33 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213674-001	9126941	2026-05-15	U-2345		2020-09-03
N213674-001	9126941	2026-05-15	U-2708		2020-09-03
N213674-001	9126941	2026-05-15	U-3763		2020-09-03
N213674-001	8183274	2026-08-24	U-2345		2020-09-03
N213674-001	8183274	2026-08-24	U-2708		2020-09-03
N213674-001	8183274	2026-08-24	U-3763		2020-09-03
N213674-001	7709517	2027-08-13		Drug substance, Drug product	2020-09-03
N213674-001	11839689	2033-09-11		Drug product	2023-12-19
N213674-001	12502357	2033-09-11	U-4363		2026-01-07
N213674-001	12502357	2033-09-11	U-4364		2026-01-07
N213674-001	12502357	2033-09-11	U-4365		2026-01-07
N213674-001	12161628	2037-02-23	U-4101		2025-01-08
N213674-001	12161628	2037-02-23	U-4102		2025-01-08
N213674-001	12161628	2037-02-23	U-4103		2025-01-08
N213674-001	12161628	2037-02-23	U-4104		2025-01-08
N213674-002	9126941	2026-05-15	U-2345		2020-09-03
N213674-002	9126941	2026-05-15	U-2708		2020-09-03
N213674-002	9126941	2026-05-15	U-3763		2020-09-03
N213674-002	8183274	2026-08-24	U-2345		2020-09-03
N213674-002	8183274	2026-08-24	U-2708		2020-09-03
N213674-002	8183274	2026-08-24	U-3763		2020-09-03
N213674-002	7709517	2027-08-13		Drug substance, Drug product	2020-09-03
N213674-002	11839689	2033-09-11		Drug product	2023-12-19
N213674-002	12447128	2033-09-11	U-4312		2025-11-17
N213674-002	12447128	2033-09-11	U-4313		2025-11-17
N213674-002	12447128	2033-09-11	U-4314		2025-11-17
N213674-002	12502357	2033-09-11	U-4363		2026-01-07
N213674-002	12502357	2033-09-11	U-4364		2026-01-07
N213674-002	12502357	2033-09-11	U-4365		2026-01-07
N213674-002	12161628	2037-02-23	U-4101		2025-01-08
N213674-002	12161628	2037-02-23	U-4102		2025-01-08
N213674-002	12161628	2037-02-23	U-4103		2025-01-08
N213674-002	12161628	2037-02-23	U-4104		2025-01-08

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 · 76 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
2026-08-18 06:07:40	2026-07	N213674-001	XTANDI	40MG	TABLET / ORAL	AB	RLD	2020-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	XTANDI	80MG	TABLET / ORAL	AB	RLD, RS	2020-08-04	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N213674-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	AB	1	`caaa826d4ba7…`
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 15 · 574 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213674-001	9126941	2026-05-15	U-2708		2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	9126941	2026-05-15	U-2345		2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	9126941	2026-05-15	U-3763		2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	8183274	2026-08-24	U-2345		2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	8183274	2026-08-24	U-2708		2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	8183274	2026-08-24	U-3763		2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	7709517	2027-08-13		Drug substance, Drug product	2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	11839689	2033-09-11		Drug product	2023-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	12502357	2033-09-11	U-4363		2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	12502357	2033-09-11	U-4364		2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	12502357	2033-09-11	U-4365		2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	12161628	2037-02-23	U-4101		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	12161628	2037-02-23	U-4102		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	12161628	2037-02-23	U-4103		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-001	12161628	2037-02-23	U-4104		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	9126941	2026-05-15	U-2708		2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	9126941	2026-05-15	U-2345		2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	9126941	2026-05-15	U-3763		2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	8183274	2026-08-24	U-2708		2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	8183274	2026-08-24	U-2345		2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	8183274	2026-08-24	U-3763		2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	7709517	2027-08-13		Drug substance, Drug product	2020-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	11839689	2033-09-11		Drug product	2023-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	12447128	2033-09-11	U-4312		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	12447128	2033-09-11	U-4313		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	12447128	2033-09-11	U-4314		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	12502357	2033-09-11	U-4363		2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	12502357	2033-09-11	U-4364		2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	12502357	2033-09-11	U-4365		2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	12161628	2037-02-23	U-4102		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	12161628	2037-02-23	U-4103		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	12161628	2037-02-23	U-4104		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	12161628	2037-02-23	U-4101		2025-01-08	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N213674-001	I-926	2026-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213674-002	I-926	2026-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213674-001	I-926	2026-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213674-002	I-926	2026-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213674-001	I-926	2026-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213674-002	I-926	2026-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213674-001	I-926	2026-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213674-002	I-926	2026-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213674-001	I-926	2026-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213674-002	I-926	2026-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213674-001	I-926	2026-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213674-002	I-926	2026-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213674-001	I-926	2026-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213674-002	I-926	2026-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213674-001	I-926	2026-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213674-002	I-926	2026-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213674-001	I-926	2026-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213674-002	I-926	2026-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213674-001	I-926	2026-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213674-002	I-926	2026-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213674-001	I-926	2026-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213674-002	I-926	2026-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213674-001	I-926	2026-11-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213674-002	I-926	2026-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213674-001	I-926	2026-11-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213674-002	I-926	2026-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213674-001	I-926	2026-11-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213674-002	I-926	2026-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213674-001	I-926	2026-11-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213674-002	I-926	2026-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213674-001	I-808	2022-12-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213674-002	I-808	2022-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213674-001	I-808	2022-12-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213674-002	I-808	2022-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213674-001	I-808	2022-12-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213674-002	I-808	2022-12-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213674-001	I-808	2022-12-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213674-002	I-808	2022-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213674-001	I-786	2021-07-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N213674-001	I-808	2022-12-16	`782e0a99824c…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
06830410-7a31-1c12-a87c-78c7b1a695cb	Product name	2	20211208
64cacdcb-6ac9-4f6e-84ab-15ad5c3422ea	Product name	1	20210224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0469-1725-56	Xtandi	56 in 1 BOTTLE	TABLET	56		22
0469-1725-56	Xtandi	1 in 1 CARTON	TABLET	1		22

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ENZALUTAMIDE	ACTIVE INGREDIENT	93T0T9GKNU	XTANDI (ENZALUTAMIDE) CAPSULE [ASTELLAS PHARMA US, INC.]	7
ENZALUTAMIDE	ACTIVE MOIETY	93T0T9GKNU	XTANDI (ENZALUTAMIDE) CAPSULE [ASTELLAS PHARMA US, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0469-1725	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xtandi	ENZALUTAMIDE	Astellas Pharma US, Inc.	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213674 application number: NDA213674 ndc (product): 0469-1725

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
93T0T9GKNU	ENZALUTAMIDE	915087-33-1	ENZALUTAMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1307303	enzalutamide 40 MG Oral Capsule	PSN	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
2390644	enzalutamide 40 MG Oral Tablet	PSN	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
2390648	enzalutamide 80 MG Oral Tablet	PSN	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
1307309	Xtandi 40 MG Oral Capsule	PSN	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
2390646	Xtandi 40 MG Oral Tablet	PSN	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
2390650	Xtandi 80 MG Oral Tablet	PSN	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
1307309	enzalutamide 40 MG Oral Capsule [Xtandi]	SBD	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
2390646	enzalutamide 40 MG Oral Tablet [Xtandi]	SBD	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
2390650	enzalutamide 80 MG Oral Tablet [Xtandi]	SBD	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
1307303	enzalutamide 40 MG Oral Capsule	SCD	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
2390644	enzalutamide 40 MG Oral Tablet	SCD	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
2390648	enzalutamide 80 MG Oral Tablet	SCD	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
1307309	Xtandi 40 MG Oral Capsule	SY	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
2390646	Xtandi 40 MG Oral Tablet	SY	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22
2390650	Xtandi 80 MG Oral Tablet	SY	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0469-1725-56	00469172556	1 BOTTLE in 1 CARTON (0469-1725-56) / 56 TABLET in 1 BOTTLE	1 bottle	2020-08-04	0000-00-00	Yes	No	Current