Rubraca

Product NDC: 69660-203
11-digit product format: 696600203
Labeler code: 69660
Product ID: 69660-203_6377c685-557e-45d5-b860-530973ca8fcc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rucaparib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Clovis Oncology, Inc.
Application: NDA209115
Marketing category: NDA
Marketing start: 2016-12-19
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	69660-203		D	Discontinued by firm		2026-07-31
excluded package	package	69660-203	69660-203-91	D	Discontinued by firm		2026-07-31

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69660-203-91	EA - Each	69660-203	f48565bf-4ff1-4e56-97d8-657fc2be354b	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69660-203	RUBRACA (RUCAPARIB) TABLET, FILM COATED [CLOVIS ONCOLOGY, INC.]	14	Legacy NDC	20240223_a6d46c03-bb1d-417b-b8e5-3bffe352fe29.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69660-203-91	69660020391	60 TABLET, FILM COATED in 1 BOTTLE (69660-203-91)	2016-12-19	0000-00-00	No	No	Current