AKEEGA

Product NDC: 57894-050
11-digit product format: 578940050
Labeler code: 57894
Product ID: 57894-050_463bff67-d7cf-a132-e063-6394a90abe1d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Janssen Biotech, Inc.
Application: NDA216793
Marketing category: NDA
Marketing start: 2023-08-11
Substance: ABIRATERONE ACETATE; NIRAPARIB TOSYLATE MONOHYDRATE
Active strength: 500; 50 mg/1; mg/1
Pharmacologic classes: Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [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
N216793-001	AKEEGA	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2023-08-11
N216793-002	AKEEGA	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE	500MG;EQ 100MG BASE	TABLET / ORAL		RLD, RS	2023-08-11

Orange Book patents#

Current patent rows page 1 of 1 · 44 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216793-001	8071579	2027-08-12	U-2830		2023-09-06
N216793-001	8071579	2027-08-12	U-4368		2023-09-06
N216793-001	8143241	2027-08-12	U-2830		2023-09-06
N216793-001	8143241	2027-08-12	U-4368		2023-09-06
N216793-001	8436185	2029-04-24		Drug substance, Drug product	2023-09-06
N216793-001	8071623	2031-03-27		Drug substance, Drug product	2023-09-06
N216793-001	8859562	2031-08-04	U-2830		2023-09-06
N216793-001	8859562	2031-08-04	U-4368		2023-09-06
N216793-001	11207311	2037-07-28	U-2830		2023-09-06
N216793-001	11207311	2037-07-28	U-4368		2023-09-06
N216793-001	11986468	2037-07-28	U-2830		2024-07-02
N216793-001	11986468	2037-07-28	U-4368		2024-07-02
N216793-001	11986469	2037-07-28	U-2830		2024-07-02
N216793-001	11986469	2037-07-28	U-4368		2024-07-02
N216793-001	11986470	2037-07-28	U-4368		2026-01-09
N216793-001	11992486	2037-07-28	U-2830		2024-07-02
N216793-001	11992486	2037-07-28	U-4368		2024-07-02
N216793-001	12383543	2037-07-28	U-2830		2025-09-11
N216793-001	12383543	2037-07-28	U-4368		2025-09-11
N216793-001	11091459	2038-03-27		Drug substance, Drug product	2023-09-06
N216793-001	11673877	2038-03-27	U-2830	Drug substance, Drug product	2023-09-06
N216793-001	11673877	2038-03-27	U-4368	Drug substance, Drug product	2023-09-06
N216793-002	8071579	2027-08-12	U-2830		2023-09-06
N216793-002	8071579	2027-08-12	U-4368		2023-09-06
N216793-002	8143241	2027-08-12	U-2830		2023-09-06
N216793-002	8143241	2027-08-12	U-4368		2023-09-06
N216793-002	8436185	2029-04-24		Drug substance, Drug product	2023-09-06
N216793-002	8071623	2031-03-27		Drug substance, Drug product	2023-09-06
N216793-002	8859562	2031-08-04	U-2830		2023-09-06
N216793-002	8859562	2031-08-04	U-4368		2023-09-06
N216793-002	11207311	2037-07-28	U-2830		2023-09-06
N216793-002	11207311	2037-07-28	U-4368		2023-09-06
N216793-002	11986468	2037-07-28	U-2830		2024-07-02
N216793-002	11986468	2037-07-28	U-4368		2024-07-02
N216793-002	11986469	2037-07-28	U-2830		2024-07-02
N216793-002	11986469	2037-07-28	U-4368		2024-07-02
N216793-002	11986470	2037-07-28	U-4368		2026-01-09
N216793-002	11992486	2037-07-28	U-2830		2024-07-02
N216793-002	11992486	2037-07-28	U-4368		2024-07-02
N216793-002	12383543	2037-07-28	U-2830		2025-09-11
N216793-002	12383543	2037-07-28	U-4368		2025-09-11
N216793-002	11091459	2038-03-27		Drug substance, Drug product	2023-09-06
N216793-002	11673877	2038-03-27	U-2830	Drug substance, Drug product	2023-09-06
N216793-002	11673877	2038-03-27	U-4368	Drug substance, Drug product	2023-09-06

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216793-001	NP	2026-08-11
N216793-001	I-980	2028-12-12
N216793-002	NP	2026-08-11
N216793-002	I-980	2028-12-12

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 444 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	N216793-001	8071579	2027-08-12	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8071579	2027-08-12	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8143241	2027-08-12	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8143241	2027-08-12	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8436185	2029-04-24		Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8071623	2031-03-27		Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8859562	2031-08-04	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8859562	2031-08-04	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11207311	2037-07-28	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11207311	2037-07-28	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11986468	2037-07-28	U-4368		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11986468	2037-07-28	U-2830		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11986469	2037-07-28	U-4368		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11986469	2037-07-28	U-2830		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11986470	2037-07-28	U-4368		2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11992486	2037-07-28	U-4368		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11992486	2037-07-28	U-2830		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	12383543	2037-07-28	U-4368		2025-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	12383543	2037-07-28	U-2830		2025-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11091459	2038-03-27		Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11673877	2038-03-27	U-2830	Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11673877	2038-03-27	U-4368	Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8071579	2027-08-12	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8071579	2027-08-12	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8143241	2027-08-12	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8143241	2027-08-12	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8436185	2029-04-24		Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8071623	2031-03-27		Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8859562	2031-08-04	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8859562	2031-08-04	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11207311	2037-07-28	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11207311	2037-07-28	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11986468	2037-07-28	U-4368		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11986468	2037-07-28	U-2830		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11986469	2037-07-28	U-4368		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11986469	2037-07-28	U-2830		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11986470	2037-07-28	U-4368		2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11992486	2037-07-28	U-4368		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11992486	2037-07-28	U-2830		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	12383543	2037-07-28	U-4368		2025-09-11	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216793-001	NP	2026-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	I-980	2028-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	NP	2026-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	I-980	2028-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216793-001	NP	2026-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216793-002	NP	2026-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216793-001	NP	2026-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216793-002	NP	2026-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216793-001	NP	2026-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216793-002	NP	2026-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216793-001	NP	2026-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216793-002	NP	2026-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216793-001	NP	2026-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216793-002	NP	2026-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216793-001	NP	2026-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216793-002	NP	2026-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216793-001	NP	2026-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216793-002	NP	2026-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216793-001	NP	2026-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216793-002	NP	2026-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216793-001	NP	2026-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216793-002	NP	2026-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216793-001	NP	2026-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216793-002	NP	2026-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216793-001	NP	2026-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216793-002	NP	2026-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216793-001	NP	2026-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216793-002	NP	2026-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216793-001	NP	2026-08-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216793-002	NP	2026-08-11	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216793-001	NP	2026-08-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216793-002	NP	2026-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216793-001	NP	2026-08-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216793-002	NP	2026-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216793-001	NP	2026-08-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216793-002	NP	2026-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216793-001	NP	2026-08-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216793-002	NP	2026-08-11	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216793-001	NP	2026-08-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216793-001	I-980	2028-12-12	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIRAPARIB TOSYLATE MONOHYDRATE	500 mg/1
ABIRATERONE ACETATE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EM5OCB9YJ6	Internal UNII lookup
195Q483UZD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2645244	Internal RxNorm lookup
2645250	Internal RxNorm lookup
2645251	Internal RxNorm lookup
2645253	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
8245a990-3268-4613-b5c5-9537858a1eb9	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
8f213b7a-23f6-497c-a54d-8a37f1798781	Product name	1	20231023
595c26ad-ded5-4c95-8cbc-96d487123743	Product name	1	20231010
fb7d5d26-0d70-42a5-a005-42898b3cfc3f	Product name	1	20180730
98474c8b-00f8-4165-be9e-bc8fe5ad84d0	Product name	1	20170608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57894-050-60	AKEEGA	1 in 1 CARTON	TABLET, FILM COATED	1		3
57894-050-60	AKEEGA	60 in 1 BOTTLE	TABLET, FILM COATED	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57894-050-60	EA - Each	57894-050	5dcaf647-922a-4482-9895-f063a1509281	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57894-050	AKEEGA (NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE) TABLET, FILM COATED [JANSSEN BIOTECH, INC.]	2	Current NDC, 2 package rows	20240820_8245a990-3268-4613-b5c5-9537858a1eb9.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
AKEEGA	NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE	Janssen Biotech, Inc.	8245a990-3268-4613-b5c5-9537858a1eb9	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216793 application number: NDA216793 ndc (product): 57894-050

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EM5OCB9YJ6	ABIRATERONE ACETATE	154229-18-2	ABIRATERONE ACETATE
195Q483UZD	NIRAPARIB TOSYLATE MONOHYDRATE	1613220-15-7	NIRAPARIB TOSYLATE MONOHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2645253	Akeega 100 MG / 500 MG Oral Tablet	PSN	8245a990-3268-4613-b5c5-9537858a1eb9	3
2645250	Akeega 50 MG / 500 MG Oral Tablet	PSN	8245a990-3268-4613-b5c5-9537858a1eb9	3
2645251	niraparib 100 MG / abiraterone acetate 500 MG Oral Tablet	PSN	8245a990-3268-4613-b5c5-9537858a1eb9	3
2645244	niraparib 50 MG / abiraterone acetate 500 MG Oral Tablet	PSN	8245a990-3268-4613-b5c5-9537858a1eb9	3
2645253	abiraterone acetate 500 MG / niraparib 100 MG Oral Tablet [Akeega]	SBD	8245a990-3268-4613-b5c5-9537858a1eb9	3
2645250	abiraterone acetate 500 MG / niraparib 50 MG Oral Tablet [Akeega]	SBD	8245a990-3268-4613-b5c5-9537858a1eb9	3
2645251	abiraterone acetate 500 MG / niraparib 100 MG Oral Tablet	SCD	8245a990-3268-4613-b5c5-9537858a1eb9	3
2645244	abiraterone acetate 500 MG / niraparib 50 MG Oral Tablet	SCD	8245a990-3268-4613-b5c5-9537858a1eb9	3
2645251	abiraterone acetate 500 MG / niraparib 100 MG (equivalent to 153.7 MG niraparib tosylate) Oral Tablet	SY	8245a990-3268-4613-b5c5-9537858a1eb9	3
2645244	abiraterone acetate 500 MG / niraparib 50 MG (equivalent to 76.9 MG niraparib tosylate) Oral Tablet	SY	8245a990-3268-4613-b5c5-9537858a1eb9	3
2645253	Akeega (abiraterone acetate 500 MG / niraparib 100 MG (equivalent to 153.7 MG niraparib tosylate)) Oral Tablet	SY	8245a990-3268-4613-b5c5-9537858a1eb9	3
2645250	Akeega (abiraterone acetate 500 MG / niraparib 50 MG (equivalent to 76.9 MG niraparib tosylate)) Oral Tablet	SY	8245a990-3268-4613-b5c5-9537858a1eb9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
57894-050-60	57894005060	1 BOTTLE in 1 CARTON (57894-050-60) / 60 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2023-08-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AKEEGA	Janssen Biotech, Inc. \| Shanghai SynTheAll Pharmaceutical Co., Ltd. \| Changzhou SynTheAll Pharmaceutical Co., Ltd. \| Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. \| Zhejiang Xianju Junye Pharmaceutical Co., Ltd. \| Pharmacia & Upjohn Company LLC \| Janssen Pharmaceutica NV \| Patheon France S.A.S \| Janssen Cilag SpA \| Johnson & Johnson Private Limited	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	3