ERLEADA

Product NDC: 59676-600
Requested package NDC: 59676-600-99
11-digit product format: 596760600
Labeler code: 59676
Product ID: 59676-600_8d917bea-59a6-4338-b818-6ad5c62d02f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Apalutamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Janssen Products, LP
Application: NDA210951
Marketing category: NDA
Marketing start: 2018-02-14
Substance: APALUTAMIDE
Active strength: 60 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59676-600	59676-600-99	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N210951-001	ERLEADA	APALUTAMIDE	60MG	TABLET / ORAL	AB	RLD	2018-02-14
N210951-002	ERLEADA	APALUTAMIDE	240MG	TABLET / ORAL		RLD, RS	2023-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N210951-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 36 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210951-001	8802689	2027-03-27	U-2237		2018-03-05
N210951-001	8802689	2027-03-27	U-2624		2018-03-05
N210951-001	9388159	2027-03-27		Drug substance, Drug product	2018-03-05
N210951-001	9987261	2027-03-27		Drug product	2018-10-18
N210951-001	8445507	2032-02-14	U-2237	Drug substance, Drug product	2018-03-05
N210951-001	8445507	2032-02-14	U-2624	Drug substance, Drug product	2018-03-05
N210951-001	9481663	2033-06-04	U-2237	Drug substance, Drug product	2018-03-05
N210951-001	9481663	2033-06-04	U-2624	Drug substance, Drug product	2018-03-05
N210951-001	10849888	2033-09-23	U-3013		2021-01-05
N210951-001	9884054	2033-09-23	U-2237		2018-03-05
N210951-001	RE49353	2033-09-23	U-2381		2023-01-12
N210951-001	RE50642	2033-09-23	U-4450		2026-04-02
N210951-001	12303493	2035-12-03		Drug product	2025-06-16
N210951-001	10702508	2038-04-30	U-3012		2021-01-05
N210951-001	11963952	2040-01-30	U-3901		2024-04-26
N210951-001	12303497	2040-01-30	U-4448		2025-06-16
N210951-001	12303497	2040-01-30	U-4494		2025-06-16
N210951-001	11723898	2041-01-14	U-4449		2026-04-02
N210951-002	8802689	2027-03-27	U-2237		2023-02-27
N210951-002	8802689	2027-03-27	U-2624		2023-02-27
N210951-002	9388159	2027-03-27		Drug substance, Drug product	2023-02-27
N210951-002	9987261	2027-03-27		Drug product	2023-02-27
N210951-002	8445507	2032-02-14	U-2237	Drug substance, Drug product	2023-02-27
N210951-002	8445507	2032-02-14	U-2624	Drug substance, Drug product	2023-02-27
N210951-002	9481663	2033-06-04	U-2237	Drug substance, Drug product	2023-02-27
N210951-002	9481663	2033-06-04	U-2624	Drug substance, Drug product	2023-02-27
N210951-002	10849888	2033-09-23	U-3013		2023-02-27
N210951-002	9884054	2033-09-23	U-2237		2023-02-27
N210951-002	RE49353	2033-09-23	U-2381		2023-02-27
N210951-002	RE50642	2033-09-23	U-4450		2026-04-02
N210951-002	12303493	2035-12-03		Drug product	2025-06-16
N210951-002	10702508	2038-04-30	U-3012		2023-02-27
N210951-002	11963952	2040-01-30	U-3901		2024-04-26
N210951-002	12303497	2040-01-30	U-4448		2025-06-16
N210951-002	12303497	2040-01-30	U-4494		2025-06-16
N210951-002	11723898	2041-01-14	U-4449		2026-04-02

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 · 64 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	N210951-001	ERLEADA	60MG	TABLET / ORAL	AB	RLD	2018-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-001	ERLEADA	60MG	TABLET / ORAL	AB	RLD	2018-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210951-001	ERLEADA	60MG	TABLET / ORAL	AB	RLD	2018-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`b00525d2431f…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210951-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210951-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210951-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 856 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	N210951-001	8802689	2027-03-27	U-2237		2018-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	8802689	2027-03-27	U-2624		2018-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	9388159	2027-03-27		Drug substance, Drug product	2018-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	9987261	2027-03-27		Drug product	2018-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	8445507	2030-09-15	U-2624	Drug substance, Drug product	2018-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	8445507	2030-09-15	U-2237	Drug substance, Drug product	2018-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	9481663	2033-06-04	U-2624	Drug substance, Drug product	2018-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	9481663	2033-06-04	U-2237	Drug substance, Drug product	2018-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	10849888	2033-09-23	U-3013		2021-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	9884054	2033-09-23	U-2237		2018-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	RE49353	2033-09-23	U-2381		2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	12303493	2035-12-03		Drug product	2025-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	10702508	2038-04-30	U-3012		2021-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	11963952	2040-01-30	U-3901		2024-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	12303497	2040-01-30	U-4201		2025-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-001	12303497	2040-01-30	U-4202		2025-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	8802689	2027-03-27	U-2237		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	8802689	2027-03-27	U-2624		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	9388159	2027-03-27		Drug substance, Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	9987261	2027-03-27		Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	8445507	2030-09-15	U-2237	Drug substance, Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	8445507	2030-09-15	U-2624	Drug substance, Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	9481663	2033-06-04	U-2624	Drug substance, Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	9481663	2033-06-04	U-2237	Drug substance, Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	10849888	2033-09-23	U-3013		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	9884054	2033-09-23	U-2237		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	RE49353	2033-09-23	U-2381		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	12303493	2035-12-03		Drug product	2025-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	10702508	2038-04-30	U-3012		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	11963952	2040-01-30	U-3901		2024-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	12303497	2040-01-30	U-4201		2025-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	12303497	2040-01-30	U-4202		2025-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-001	8802689	2027-03-27	U-2237		2018-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-001	8802689	2027-03-27	U-2624		2018-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-001	9388159	2027-03-27		Drug substance, Drug product	2018-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-001	9987261	2027-03-27		Drug product	2018-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-001	8445507	2030-09-15	U-2624	Drug substance, Drug product	2018-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-001	8445507	2030-09-15	U-2237	Drug substance, Drug product	2018-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-001	9481663	2033-06-04	U-2624	Drug substance, Drug product	2018-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-001	9481663	2033-06-04	U-2237	Drug substance, Drug product	2018-03-05	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210951-001	I-808	2022-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210951-001	NCE	2023-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210951-001	I-808	2022-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210951-001	NCE	2023-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210951-001	I-808	2022-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210951-001	NCE	2023-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210951-001	I-808	2022-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210951-001	NCE	2023-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210951-001	I-808	2022-09-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210951-001	NCE	2023-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210951-001	I-808	2022-09-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210951-001	NCE	2023-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210951-001	I-808	2022-09-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210951-001	NCE	2023-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210951-001	I-808	2022-09-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210951-001	NCE	2023-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210951-001	I-808	2022-09-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210951-001	NCE	2023-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210951-001	I-808	2022-09-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210951-001	NCE	2023-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210951-001	I-808	2022-09-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N210951-001	NCE	2023-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210951-001	NCE	2023-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210951-001	NCE	2023-02-14	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N210951-001	NCE	2023-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210951-001	NCE	2023-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210951-001	NCE	2023-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210951-001	NCE	2023-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210951-001	NCE	2023-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210951-001	NCE	2023-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210951-001	I-808	2022-09-17	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N210951-001	NCE	2023-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210951-001	I-808	2022-09-17	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210951-001	NCE	2023-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210951-001	I-808	2022-09-17	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N210951-001	NCE	2023-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210951-001	I-808	2022-09-17	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N210951-001	NCE	2023-02-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210951-001	I-808	2022-09-17	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210951-001	NCE	2023-02-14	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: ERLEADA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
APALUTAMIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4T36H88UA7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1999581	Internal RxNorm lookup
1999587	Internal RxNorm lookup
2630215	Internal RxNorm lookup
2630217	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
d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e642a8ac-f854-4f01-9fba-01eef6be7381	Product name	3	20260105

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59676-600-12	ERLEADA	120 in 1 BOTTLE	TABLET, FILM COATED	120	28
59676-600-56	ERLEADA	2 in 1 CARTON	TABLET, FILM COATED	2	28
59676-600-56	ERLEADA	28 in 1 BLISTER PACK	TABLET, FILM COATED	28	28
59676-600-99	ERLEADA	120 in 1 BOTTLE	TABLET, FILM COATED	120	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59676-600-12	EA - Each	59676-600	250f9d2f-78bf-4b1d-9a55-00c7b6944add	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59676-600	ERLEADA (APALUTAMIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	26	Current NDC, Legacy NDC, 4 package rows	20250406_d1cda4f7-cb33-46ea-b9ac-431f6452b1a5.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
ERLEADA	APALUTAMIDE	Janssen Products, LP	d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210951 application number: NDA210951 ndc (package): 59676-600-99 ndc (product): 59676-600 ndc11 (package): 59676060099

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T36H88UA7	APALUTAMIDE	956104-40-8	APALUTAMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2630215	apalutamide 240 MG Oral Tablet	PSN	d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	28
1999581	apalutamide 60 MG Oral Tablet	PSN	d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	28
2630217	Erleada 240 MG Oral Tablet	PSN	d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	28
1999587	Erleada 60 MG Oral Tablet	PSN	d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	28
2630217	apalutamide 240 MG Oral Tablet [Erleada]	SBD	d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	28
1999587	apalutamide 60 MG Oral Tablet [Erleada]	SBD	d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	28
2630215	apalutamide 240 MG Oral Tablet	SCD	d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	28
1999581	apalutamide 60 MG Oral Tablet	SCD	d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	28
2630217	Erleada 240 MG Oral Tablet	SY	d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	28
1999587	Erleada 60 MG Oral Tablet	SY	d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59676-600-99	59676060099	120 TABLET, FILM COATED in 1 BOTTLE (59676-600-99)	2018-02-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ERLEADA	Janssen Products, LP \| Janssen Pharmaceuticals, Inc. \| Janssen Pharmaceutica NV \| Janssen Cilag SpA \| Johnson & Johnson Private Limited \| Janssen Ortho LLC \| Catalent Pharma Solutions, LLC	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	29