Nilandron

Product NDC: 59212-111
11-digit product format: 592120111
Labeler code: 59212
Product ID: 59212-111_e834bedb-32de-4f3a-b9f3-cb5f4804d046
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nilutamide
Dosage form: TABLET
Route: ORAL
Labeler: Concordia Pharmaceuticals Inc.
Application: NDA020169
Marketing category: NDA
Marketing start: 2013-07-15
Marketing end: 0000-00-00
Substance: NILUTAMIDE
Active strength: 150 mg/1
Pharmacologic classes: Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	59212-111		D	Discontinued by firm		2026-08-11
excluded package	package	59212-111	59212-111-14	D	Discontinued by firm		2026-08-11

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
N020169-001	NILANDRON	NILUTAMIDE	50MG	TABLET / ORAL			1996-09-19
N020169-002	NILANDRON	NILUTAMIDE	150MG	TABLET / ORAL		RLD	1999-04-30

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 3 · 82 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	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020169-001	NILANDRON	50MG	TABLET / ORAL			1996-09-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020169-002	NILANDRON	150MG	TABLET / ORAL	AB	RLD, RS	1999-04-30	`782e0a99824c…`

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	N020169-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020169-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020169-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020169-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020169-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020169-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020169-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020169-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020169-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020169-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020169-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020169-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020169-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020169-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020169-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020169-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020169-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020169-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020169-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020169-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020169-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020169-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020169-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020169-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020169-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020169-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020169-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020169-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020169-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020169-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020169-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020169-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020169-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020169-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020169-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020169-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020169-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020169-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020169-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020169-002	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3bc37720-50af-a914-81af-efa29d7b589a	Product name	2	20160823

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59212-111-14	EA - Each	59212-111	f2e23379-e1eb-49fd-b817-656972e85c89	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59212-111	NILANDRON (NILUTAMIDE) TABLET [ADVANZ PHARMA (US) CORP.]	8	Legacy NDC	20241210_5ccf0e9a-8935-4c8c-b883-b4967281eb4a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
51G6I8B902	NILUTAMIDE	63612-50-0	NILUTAMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59212-111-14	59212011114	3 BLISTER PACK in 1 CARTON (59212-111-14) > 10 TABLET in 1 BLISTER PACK	3 blister pack	2013-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NILANDRON ® (nilutamide) Tablets	Advanz Pharma (US) Corp.	2025-12-12	Human Prescription Drug Label	9