Zytiga

Product NDC: 57894-150
11-digit product format: 578940150
Labeler code: 57894
Product ID: 57894-150_316974bf-2b6d-9d66-e063-6294a90a33a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: abiraterone acetate
Dosage form: TABLET
Route: ORAL
Labeler: Janssen Biotech, Inc.
Application: NDA202379
Marketing category: NDA
Marketing start: 2011-04-28
Substance: ABIRATERONE ACETATE
Active strength: 250 mg/1
Pharmacologic classes: Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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	57894-150	57894-150-25	D	Discontinued by firm		2026-08-17

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 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
N202379-001	ZYTIGA	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	RLD	2011-04-28
N202379-002	ZYTIGA	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N202379-001	AB
N202379-002	AB

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 · 84 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	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202379-002	ZYTIGA	500MG	TABLET / ORAL		RLD, RS	2017-04-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202379-001	ZYTIGA	250MG	TABLET / ORAL	AB	RLD	2011-04-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202379-002	ZYTIGA	500MG	TABLET / ORAL	AB	RLD, RS	2017-04-14	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N202379-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202379-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202379-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202379-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202379-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202379-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202379-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202379-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202379-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202379-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202379-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202379-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202379-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202379-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202379-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202379-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202379-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202379-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202379-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202379-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202379-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202379-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202379-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202379-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202379-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202379-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202379-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202379-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202379-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202379-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202379-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202379-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202379-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202379-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202379-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202379-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202379-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202379-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202379-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202379-001	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N202379-002	8822438	2027-08-24	U-2235	Delist requested	2017-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202379-002	8822438	2027-08-24	U-1580	Delist requested	2017-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202379-002	8822438	2027-08-24	U-1579	Delist requested	2017-08-02	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N202379-002	8822438	2027-08-24	U-2235	Delist requested	2017-08-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202379-002	8822438	2027-08-24	U-1580	Delist requested	2017-08-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202379-002	8822438	2027-08-24	U-1579	Delist requested	2017-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202379-002	8822438	2027-08-24	U-2235	Delist requested	2017-08-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202379-002	8822438	2027-08-24	U-1580	Delist requested	2017-08-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202379-002	8822438	2027-08-24	U-1579	Delist requested	2017-08-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202379-002	8822438	2027-08-24	U-2235	Delist requested	2017-08-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202379-002	8822438	2027-08-24	U-1580	Delist requested	2017-08-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202379-002	8822438	2027-08-24	U-1579	Delist requested	2017-08-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202379-001	8822438	2027-08-24	U-1580		2014-10-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202379-001	8822438	2027-08-24	U-2235		2014-10-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202379-001	8822438	2027-08-24	U-1579		2014-10-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202379-002	8822438	2027-08-24	U-2235		2017-08-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202379-002	8822438	2027-08-24	U-1580		2017-08-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202379-002	8822438	2027-08-24	U-1579		2017-08-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202379-001	8822438	2027-08-24	U-1579		2014-10-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202379-001	8822438	2027-08-24	U-1580		2014-10-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202379-001	8822438	2027-08-24	U-2235		2014-10-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202379-002	8822438	2027-08-24	U-2235		2017-08-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202379-002	8822438	2027-08-24	U-1580		2017-08-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202379-002	8822438	2027-08-24	U-1579		2017-08-02	`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N202379-001	I-765	2021-02-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202379-002	I-765	2021-02-07	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N202379-001	I-765	2021-02-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202379-002	I-765	2021-02-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202379-001	I-765	2021-02-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202379-002	I-765	2021-02-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202379-001	I-765	2021-02-07	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202379-002	I-765	2021-02-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202379-001	I-765	2021-02-07	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202379-002	I-765	2021-02-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202379-001	I-765	2021-02-07	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202379-002	I-765	2021-02-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202379-001	I-765	2021-02-07	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202379-002	I-765	2021-02-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202379-001	I-765	2021-02-07	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202379-002	I-765	2021-02-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202379-001	I-765	2021-02-07	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202379-002	I-765	2021-02-07	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Zytiga
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ABIRATERONE ACETATE	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EM5OCB9YJ6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1100075	Internal RxNorm lookup
1100079	Internal RxNorm lookup
1918042	Internal RxNorm lookup
1918044	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
4e338e89-3cf2-48eb-b6e2-a06c608c6513	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e8e8aba9-b811-8b6a-ff1e-1aec10655d95	Product name	8	20240223
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
8f213b7a-23f6-497c-a54d-8a37f1798781	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
fb7d5d26-0d70-42a5-a005-42898b3cfc3f	Product name	1	20180730
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57894-150-12	Zytiga	120 in 1 BOTTLE	TABLET	120		40
57894-150-25	Zytiga	120 in 1 BOTTLE	TABLET	120		40

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57894-150-12	EA - Each	57894-150	1c8d5038-cf84-4a8d-9081-959bfffcf30c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
abiraterone acetate	ACTIVE INGREDIENT	EM5OCB9YJ6	ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]	16
abiraterone	ACTIVE MOIETY	G819A456D0	ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]	16
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]	16
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]	16
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]	16
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]	16
povidones	INACTIVE INGREDIENT	FZ989GH94E	ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]	16
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]	16
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57894-150	ZYTIGA (ABIRATERONE ACETATE) TABLET ZYTIGA (ABIRATERONE ACETATE) TABLET, FILM COATED [JANSSEN BIOTECH, INC.]	40	Current NDC, Legacy NDC, 2 package rows	20250331_4e338e89-3cf2-48eb-b6e2-a06c608c6513.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
Zytiga	ABIRATERONE ACETATE	Janssen Biotech, Inc.	4e338e89-3cf2-48eb-b6e2-a06c608c6513	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202379 application number: NDA202379 ndc (product): 57894-150

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EM5OCB9YJ6	ABIRATERONE ACETATE	154229-18-2	ABIRATERONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1100075	abiraterone acetate 250 MG Oral Tablet	PSN	4e338e89-3cf2-48eb-b6e2-a06c608c6513	40
1918042	abiraterone acetate 500 MG Oral Tablet	PSN	4e338e89-3cf2-48eb-b6e2-a06c608c6513	40
1100079	Zytiga 250 MG Oral Tablet	PSN	4e338e89-3cf2-48eb-b6e2-a06c608c6513	40
1918044	Zytiga 500 MG Oral Tablet	PSN	4e338e89-3cf2-48eb-b6e2-a06c608c6513	40
1100079	abiraterone acetate 250 MG Oral Tablet [Zytiga]	SBD	4e338e89-3cf2-48eb-b6e2-a06c608c6513	40
1918044	abiraterone acetate 500 MG Oral Tablet [Zytiga]	SBD	4e338e89-3cf2-48eb-b6e2-a06c608c6513	40
1100075	abiraterone acetate 250 MG Oral Tablet	SCD	4e338e89-3cf2-48eb-b6e2-a06c608c6513	40
1918042	abiraterone acetate 500 MG Oral Tablet	SCD	4e338e89-3cf2-48eb-b6e2-a06c608c6513	40
1100079	Zytiga 250 MG Oral Tablet	SY	4e338e89-3cf2-48eb-b6e2-a06c608c6513	40
1918044	Zytiga 500 MG Oral Tablet	SY	4e338e89-3cf2-48eb-b6e2-a06c608c6513	40

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57894-150-12	57894015012	120 TABLET in 1 BOTTLE (57894-150-12)	120 tablet	2011-04-28	0000-00-00	No	No	Current
57894-150-25	57894015025	120 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zytiga	Janssen Biotech, Inc. \| Patheon, Inc. \| Ajinomoto Omnichem \| Janssen Pharmaceutica NV \| Janssen-Cilag S.p.A. \| Patheon France S.A.S. \| Johnson & Johnson Private Limited	2025-03-28	HUMAN PRESCRIPTION DRUG LABEL	40