Rubraca

Product NDC: 69660-203
Requested package NDC: 69660-203-91
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#

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	69660-203	69660-203-91	D	Discontinued by firm		2026-08-03

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69660-203	69660-203-91	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69660-203	69660-203-91	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 77 · 3,057 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	N209115-001	8071579	2027-08-12	U-2273		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	8071579	2027-08-12	U-2012		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	8071579	2027-08-12	U-2830		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	8143241	2027-08-12	U-2012		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	8143241	2027-08-12	U-2273		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	8143241	2027-08-12	U-2830		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	10278974	2031-02-10		Drug product	2019-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	8754072	2031-02-10		Drug substance, Drug product	2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	9045487	2031-02-10		Drug substance, Drug product	2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	9861638	2031-02-10	U-2012		2018-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	9861638	2031-02-10	U-2273		2018-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	8859562	2031-08-04	U-2012		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	8859562	2031-08-04	U-2273		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	8859562	2031-08-04	U-2830		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	10130636	2035-08-17	U-2273		2018-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	10130636	2035-08-17	U-2101		2018-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	10130636	2035-08-17	U-2012		2018-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	10130636	2035-08-17	U-2830		2018-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-001	9987285	2035-08-17		Drug product	2018-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	8071579	2027-08-12	U-2273		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	8071579	2027-08-12	U-2012		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	8071579	2027-08-12	U-2830		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	8143241	2027-08-12	U-2012		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	8143241	2027-08-12	U-2273		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	8143241	2027-08-12	U-2830		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	10278974	2031-02-10		Drug product	2019-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	8754072	2031-02-10		Drug substance, Drug product	2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	9045487	2031-02-10		Drug substance, Drug product	2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	9861638	2031-02-10	U-2012		2018-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	9861638	2031-02-10	U-2273		2018-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	8859562	2031-08-04	U-2273		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	8859562	2031-08-04	U-2012		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	8859562	2031-08-04	U-2830		2016-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	10130636	2035-08-17	U-2101		2018-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	10130636	2035-08-17	U-2273		2018-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	10130636	2035-08-17	U-2012		2018-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	10130636	2035-08-17	U-2830		2018-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	9987285	2035-08-17		Drug product	2018-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-003	8071579	2027-08-12	U-2012		2017-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-003	8071579	2027-08-12	U-2273		2017-05-09	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209115-001	ODE-168	2025-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209115-002	ODE-168	2025-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209115-003	ODE-168	2025-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209115-001	ODE-168	2025-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209115-002	ODE-168	2025-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209115-003	ODE-168	2025-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209115-001	ODE-168	2025-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209115-002	ODE-168	2025-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209115-003	ODE-168	2025-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209115-001	ODE-168	2025-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209115-002	ODE-168	2025-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209115-003	ODE-168	2025-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209115-001	ODE-168	2025-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209115-002	ODE-168	2025-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209115-003	ODE-168	2025-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209115-001	ODE-168	2025-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209115-002	ODE-168	2025-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209115-003	ODE-168	2025-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209115-001	ODE-168	2025-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209115-002	ODE-168	2025-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209115-003	ODE-168	2025-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209115-001	ODE-168	2025-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209115-002	ODE-168	2025-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209115-003	ODE-168	2025-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209115-001	ODE-168	2025-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209115-002	ODE-168	2025-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209115-003	ODE-168	2025-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209115-001	ODE-168	2025-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209115-002	ODE-168	2025-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209115-003	ODE-168	2025-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209115-001	ODE-168	2025-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209115-002	ODE-168	2025-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209115-003	ODE-168	2025-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209115-001	ODE-168	2025-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209115-002	ODE-168	2025-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209115-003	ODE-168	2025-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209115-001	ODE-168	2025-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209115-002	ODE-168	2025-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209115-003	ODE-168	2025-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209115-001	I-830	2023-05-15	`5c6f7cd8ea54…`

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
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