Rubraca

Product NDC: 82154-0783
11-digit product format: 821540783
Labeler code: 82154
Product ID: 82154-0783_473a8026-e822-2a9e-e063-6294a90a5c06
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: 200 mg/1
Pharmacologic classes: 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 · 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N209115-001	8071579	2027-08-12	U-2273		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8071579	2027-08-12	U-2012		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8071579	2027-08-12	U-2830		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8143241	2027-08-12	U-2012		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8143241	2027-08-12	U-2273		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8143241	2027-08-12	U-2830		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	10278974	2031-02-10		Drug product	2019-06-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8754072	2031-02-10		Drug substance, Drug product	2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	9045487	2031-02-10		Drug substance, Drug product	2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	9861638	2031-02-10	U-2012		2018-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	9861638	2031-02-10	U-2273		2018-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8859562	2031-08-04	U-2012		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8859562	2031-08-04	U-2273		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8859562	2031-08-04	U-2830		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	10130636	2035-08-17	U-2273		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	10130636	2035-08-17	U-2101		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	10130636	2035-08-17	U-2012		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	10130636	2035-08-17	U-2830		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	9987285	2035-08-17		Drug product	2018-06-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8071579	2027-08-12	U-2273		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8071579	2027-08-12	U-2012		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8071579	2027-08-12	U-2830		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8143241	2027-08-12	U-2012		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8143241	2027-08-12	U-2273		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8143241	2027-08-12	U-2830		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	10278974	2031-02-10		Drug product	2019-06-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8754072	2031-02-10		Drug substance, Drug product	2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	9045487	2031-02-10		Drug substance, Drug product	2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	9861638	2031-02-10	U-2012		2018-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	9861638	2031-02-10	U-2273		2018-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8859562	2031-08-04	U-2273		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8859562	2031-08-04	U-2012		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8859562	2031-08-04	U-2830		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	10130636	2035-08-17	U-2101		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	10130636	2035-08-17	U-2273		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	10130636	2035-08-17	U-2012		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	10130636	2035-08-17	U-2830		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	9987285	2035-08-17		Drug product	2018-06-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-003	8071579	2027-08-12	U-2012		2017-05-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-003	8071579	2027-08-12	U-2273		2017-05-09	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N209115-001	I-982	2028-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	I-982	2028-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-003	I-982	2028-12-17	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Rubraca	RUCAPARIB	pharmaand GmbH	0295d202-1cfe-7659-e063-6294a90a476e	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209115 application number: NDA209115 ndc (product): 82154-0783

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RUCAPARIB CAMSYLATE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
41AX9SJ8KO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1862584	Internal RxNorm lookup
1862590	Internal RxNorm lookup
1862593	Internal RxNorm lookup
1862595	Internal RxNorm lookup
1921587	Internal RxNorm lookup
1921589	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
0295d202-1cfe-7659-e063-6294a90a476e	Available on FDA.report

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
82154-0783-1	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
82154-0783-1	EA - Each	82154-0783	7b1894ab-41bd-4d54-a861-fe4605c5fb61	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82154-0783	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
82154-0783-1	82154078301	60 TABLET, FILM COATED in 1 BOTTLE (82154-0783-1)	2016-12-19	No	No	Current