Rubraca

Product NDC: 82154-0785
11-digit product format: 821540785
Labeler code: 82154
Product ID: 82154-0785_5df71157-c5d5-bcca-e063-6394a90a8c55
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rucaparib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: pharmaand GmbH
Application: NDA209115
Marketing category: NDA
Marketing start: 2016-12-19
Substance: RUCAPARIB CAMSYLATE
Active strength: 300 mg/1
Pharmacologic classes: Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209115-001	RUBRACA	RUCAPARIB CAMSYLATE	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19
N209115-002	RUBRACA	RUCAPARIB CAMSYLATE	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19
N209115-003	RUBRACA	RUCAPARIB CAMSYLATE	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01

Orange Book patents#

Current patent rows page 1 of 1 · 57 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209115-001	8071579	2027-08-12	U-2012		2016-12-21
N209115-001	8071579	2027-08-12	U-2273		2016-12-21
N209115-001	8071579	2027-08-12	U-2830		2016-12-21
N209115-001	8143241	2027-08-12	U-2012		2016-12-21
N209115-001	8143241	2027-08-12	U-2273		2016-12-21
N209115-001	8143241	2027-08-12	U-2830		2016-12-21
N209115-001	10278974	2031-02-10		Drug product	2019-06-04
N209115-001	8754072	2031-02-10		Drug substance, Drug product	2016-12-21
N209115-001	9045487	2031-02-10		Drug substance, Drug product	2016-12-21
N209115-001	9861638	2031-02-10	U-2012		2018-02-06
N209115-001	9861638	2031-02-10	U-2273		2018-02-06
N209115-001	8859562	2031-08-04	U-2012		2016-12-21
N209115-001	8859562	2031-08-04	U-2273		2016-12-21
N209115-001	8859562	2031-08-04	U-2830		2016-12-21
N209115-001	10130636	2035-08-17	U-2012		2018-12-17
N209115-001	10130636	2035-08-17	U-2101		2018-12-17
N209115-001	10130636	2035-08-17	U-2273		2018-12-17
N209115-001	10130636	2035-08-17	U-2830		2018-12-17
N209115-001	9987285	2035-08-17		Drug product	2018-06-28
N209115-002	8071579	2027-08-12	U-2012		2016-12-21
N209115-002	8071579	2027-08-12	U-2273		2016-12-21
N209115-002	8071579	2027-08-12	U-2830		2016-12-21
N209115-002	8143241	2027-08-12	U-2012		2016-12-21
N209115-002	8143241	2027-08-12	U-2273		2016-12-21
N209115-002	8143241	2027-08-12	U-2830		2016-12-21
N209115-002	10278974	2031-02-10		Drug product	2019-06-04
N209115-002	8754072	2031-02-10		Drug substance, Drug product	2016-12-21
N209115-002	9045487	2031-02-10		Drug substance, Drug product	2016-12-21
N209115-002	9861638	2031-02-10	U-2012		2018-02-06
N209115-002	9861638	2031-02-10	U-2273		2018-02-06
N209115-002	8859562	2031-08-04	U-2012		2016-12-21
N209115-002	8859562	2031-08-04	U-2273		2016-12-21
N209115-002	8859562	2031-08-04	U-2830		2016-12-21
N209115-002	10130636	2035-08-17	U-2012		2018-12-17
N209115-002	10130636	2035-08-17	U-2101		2018-12-17
N209115-002	10130636	2035-08-17	U-2273		2018-12-17
N209115-002	10130636	2035-08-17	U-2830		2018-12-17
N209115-002	9987285	2035-08-17		Drug product	2018-06-28
N209115-003	8071579	2027-08-12	U-2012		2017-05-09
N209115-003	8071579	2027-08-12	U-2273		2017-05-09
N209115-003	8071579	2027-08-12	U-2830		2017-05-09
N209115-003	8143241	2027-08-12	U-2012		2017-05-09
N209115-003	8143241	2027-08-12	U-2273		2017-05-09
N209115-003	8143241	2027-08-12	U-2830		2017-05-09
N209115-003	10278974	2031-02-10		Drug product	2019-06-04
N209115-003	8754072	2031-02-10		Drug substance, Drug product	2017-05-09
N209115-003	9045487	2031-02-10		Drug substance, Drug product	2017-05-09
N209115-003	9861638	2031-02-10	U-2012		2018-02-06
N209115-003	9861638	2031-02-10	U-2273		2018-02-06
N209115-003	8859562	2031-08-04	U-2012		2017-05-09
N209115-003	8859562	2031-08-04	U-2273		2017-05-09
N209115-003	8859562	2031-08-04	U-2830		2017-05-09
N209115-003	10130636	2035-08-17	U-2012		2018-12-17
N209115-003	10130636	2035-08-17	U-2101		2018-12-17
N209115-003	10130636	2035-08-17	U-2273		2018-12-17
N209115-003	10130636	2035-08-17	U-2830		2018-12-17
N209115-003	9987285	2035-08-17		Drug product	2018-06-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209115-001	I-982	2028-12-17
N209115-002	I-982	2028-12-17
N209115-003	I-982	2028-12-17

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 1 of 81 · 3,228 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209115-001	8071579	2027-08-12	U-2273		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	8071579	2027-08-12	U-2012		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	8071579	2027-08-12	U-2830		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	8143241	2027-08-12	U-2012		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	8143241	2027-08-12	U-2273		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	8143241	2027-08-12	U-2830		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	10278974	2031-02-10		Drug product	2019-06-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	8754072	2031-02-10		Drug substance, Drug product	2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	9045487	2031-02-10		Drug substance, Drug product	2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	9861638	2031-02-10	U-2012		2018-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	9861638	2031-02-10	U-2273		2018-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	8859562	2031-08-04	U-2012		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	8859562	2031-08-04	U-2273		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	8859562	2031-08-04	U-2830		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	10130636	2035-08-17	U-2273		2018-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	10130636	2035-08-17	U-2101		2018-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	10130636	2035-08-17	U-2012		2018-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	10130636	2035-08-17	U-2830		2018-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-001	9987285	2035-08-17		Drug product	2018-06-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	8071579	2027-08-12	U-2273		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	8071579	2027-08-12	U-2012		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	8071579	2027-08-12	U-2830		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	8143241	2027-08-12	U-2012		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	8143241	2027-08-12	U-2273		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	8143241	2027-08-12	U-2830		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	10278974	2031-02-10		Drug product	2019-06-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	8754072	2031-02-10		Drug substance, Drug product	2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	9045487	2031-02-10		Drug substance, Drug product	2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	9861638	2031-02-10	U-2012		2018-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	9861638	2031-02-10	U-2273		2018-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	8859562	2031-08-04	U-2273		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	8859562	2031-08-04	U-2012		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	8859562	2031-08-04	U-2830		2016-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	10130636	2035-08-17	U-2101		2018-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	10130636	2035-08-17	U-2273		2018-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	10130636	2035-08-17	U-2012		2018-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	10130636	2035-08-17	U-2830		2018-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-002	9987285	2035-08-17		Drug product	2018-06-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-003	8071579	2027-08-12	U-2012		2017-05-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209115-003	8071579	2027-08-12	U-2273		2017-05-09	`c2088c7a36db…`

Observed Orange Book exclusivity history#

Exclusivity history page 3 of 8 · 303 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209115-002	NCE	2021-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209115-002	ODE-126	2023-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209115-002	ODE-168	2025-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209115-003	I-772	2021-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209115-003	NCE	2021-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209115-003	ODE-126	2023-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209115-003	ODE-168	2025-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209115-001	I-830	2023-05-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209115-001	ODE-126	2023-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209115-001	ODE-168	2025-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209115-002	I-830	2023-05-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209115-002	ODE-126	2023-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209115-002	ODE-168	2025-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209115-003	I-830	2023-05-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209115-003	ODE-126	2023-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209115-003	ODE-168	2025-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209115-001	I-772	2021-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-001	NCE	2021-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-001	I-830	2023-05-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-001	ODE-126	2023-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-001	ODE-168	2025-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-002	I-772	2021-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-002	NCE	2021-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-002	I-830	2023-05-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-002	ODE-126	2023-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-002	ODE-168	2025-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-003	I-772	2021-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-003	NCE	2021-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-003	I-830	2023-05-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-003	ODE-126	2023-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209115-003	ODE-168	2025-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209115-001	I-772	2021-04-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209115-001	NCE	2021-12-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209115-001	I-830	2023-05-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209115-001	ODE-126	2023-12-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209115-001	ODE-168	2025-04-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209115-002	I-772	2021-04-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209115-002	NCE	2021-12-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209115-002	I-830	2023-05-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209115-002	ODE-126	2023-12-19	`87673890dc5c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RUCAPARIB CAMSYLATE	300 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
f430e54b-e9d6-4b78-bc11-c25cef55f87c	Product name	1	20170302

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82154-0785-1	Rubraca	60 in 1 BOTTLE	TABLET, FILM COATED	60		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82154-0785-1	EA - Each	82154-0785	b2c2ee65-dce6-4c98-b518-7a6d38b533a0	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82154-0785	RUBRACA (RUCAPARIB) TABLET, FILM COATED [PHARMAAND GMBH]	18	Current NDC, 1 package rows	20250130_0295d202-1cfe-7659-e063-6294a90a476e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
41AX9SJ8KO	RUCAPARIB CAMSYLATE	1859053-21-6	RUCAPARIB CAMSYLATE
8237F3U7EH	RUCAPARIB	283173-50-2	rucaparib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1862595	Rubraca 200 MG Oral Tablet	PSN	0295d202-1cfe-7659-e063-6294a90a476e	19
1921589	Rubraca 250 MG Oral Tablet	PSN	0295d202-1cfe-7659-e063-6294a90a476e	19
1862590	Rubraca 300 MG Oral Tablet	PSN	0295d202-1cfe-7659-e063-6294a90a476e	19
1862593	rucaparib 200 MG Oral Tablet	PSN	0295d202-1cfe-7659-e063-6294a90a476e	19
1921587	rucaparib 250 MG Oral Tablet	PSN	0295d202-1cfe-7659-e063-6294a90a476e	19
1862584	rucaparib 300 MG Oral Tablet	PSN	0295d202-1cfe-7659-e063-6294a90a476e	19
1862595	rucaparib 200 MG Oral Tablet [Rubraca]	SBD	0295d202-1cfe-7659-e063-6294a90a476e	19
1921589	rucaparib 250 MG Oral Tablet [Rubraca]	SBD	0295d202-1cfe-7659-e063-6294a90a476e	19
1862590	rucaparib 300 MG Oral Tablet [Rubraca]	SBD	0295d202-1cfe-7659-e063-6294a90a476e	19
1862593	rucaparib 200 MG Oral Tablet	SCD	0295d202-1cfe-7659-e063-6294a90a476e	19
1921587	rucaparib 250 MG Oral Tablet	SCD	0295d202-1cfe-7659-e063-6294a90a476e	19
1862584	rucaparib 300 MG Oral Tablet	SCD	0295d202-1cfe-7659-e063-6294a90a476e	19
1862595	Rubraca (as rucaparib camisylate) 200 MG Oral Tablet	SY	0295d202-1cfe-7659-e063-6294a90a476e	19
1921589	Rubraca (as rucaparib camisylate) 250 MG Oral Tablet	SY	0295d202-1cfe-7659-e063-6294a90a476e	19
1862590	Rubraca (as rucaparib camisylate) 300 MG Oral Tablet	SY	0295d202-1cfe-7659-e063-6294a90a476e	19
1862595	Rubraca 200 MG Oral Tablet	SY	0295d202-1cfe-7659-e063-6294a90a476e	19
1921589	Rubraca 250 MG Oral Tablet	SY	0295d202-1cfe-7659-e063-6294a90a476e	19
1862590	Rubraca 300 MG Oral Tablet	SY	0295d202-1cfe-7659-e063-6294a90a476e	19
1921587	rucaparib (as rucaparib camisylate) 250 MG Oral Tablet	SY	0295d202-1cfe-7659-e063-6294a90a476e	19
1862593	rucaparib (as rucaparib camsylate) 200 MG Oral Tablet	SY	0295d202-1cfe-7659-e063-6294a90a476e	19
1862584	rucaparib (as rucaparib camsylate) 300 MG Oral Tablet	SY	0295d202-1cfe-7659-e063-6294a90a476e	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82154-0785-1	82154078501	60 TABLET, FILM COATED in 1 BOTTLE (82154-0785-1)	2016-12-19	No	No	Current