ZEJULA

Product NDC: 69656-103
11-digit product format: 696560103
Labeler code: 69656
Product ID: 69656-103_260fc974-c8bc-44c5-8f72-b2424254c10a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: niraparib
Dosage form: CAPSULE
Route: ORAL
Labeler: GlaxoSmithKline LLC
Application: NDA208447
Marketing category: NDA
Marketing start: 2017-03-27
Marketing end: 0000-00-00
Substance: NIRAPARIB
Active strength: 100 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69656-103		D	Discontinued by firm	2026-08-17
excluded package	package	69656-103	69656-103-30	D	Discontinued by firm	2026-08-17
excluded package	package	69656-103	69656-103-61	D	Discontinued by firm	2026-08-17

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 · 33 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69656-103-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69656-103-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69656-103-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69656-103-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69656-103-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69656-103-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69656-103-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69656-103-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69656-103-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69656-103-61	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69656-103-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69656-103-61	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69656-103-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69656-103-61	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69656-103-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69656-103-61	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69656-103-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69656-103-61	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69656-103-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69656-103-61	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69656-103-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69656-103-61	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208447-001	ZEJULA	NIRAPARIB TOSYLATE	EQ 100MG BASE	CAPSULE / ORAL		RLD	2017-03-27

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208447-001	8071579	2027-08-12	U-2655		2019-11-22
N208447-001	8143241	2027-08-12	U-2655		2019-11-22
N208447-001	8436185	2029-04-24		Drug substance	2017-04-24
N208447-001	8071623	2031-03-27		Drug substance, Drug product	2017-04-24
N208447-001	8859562	2031-08-04	U-2655		2019-11-22
N208447-001	11091459	2038-03-27		Drug product	2021-09-07
N208447-001	11673877	2038-03-27	U-3646	Drug product	2023-07-11
N208447-001	11673877	2038-03-27	U-3647	Drug product	2023-07-11

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208447-001	ODE-277	2026-10-23
N208447-001	ODE-295	2027-04-29

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD	2017-03-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208447-001	ZEJULA	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2017-03-27	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 279 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208447-001	8071579	2027-08-12	U-2655		2019-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208447-001	8143241	2027-08-12	U-2655		2019-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208447-001	8436185	2029-04-24		Drug substance	2017-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208447-001	8071623	2031-03-27		Drug substance, Drug product	2017-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208447-001	8859562	2031-08-04	U-2655		2019-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208447-001	11091459	2038-03-27		Drug product	2021-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208447-001	11673877	2038-03-27	U-3646	Drug product	2023-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208447-001	11673877	2038-03-27	U-3647	Drug product	2023-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208447-001	8071579	2027-08-12	U-2655		2019-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208447-001	8143241	2027-08-12	U-2655		2019-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208447-001	8436185	2029-04-24		Drug substance	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208447-001	8071623	2031-03-27		Drug substance, Drug product	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208447-001	8859562	2031-08-04	U-2655		2019-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208447-001	11091459	2038-03-27		Drug product	2021-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208447-001	11673877	2038-03-27	U-3646	Drug product	2023-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208447-001	11673877	2038-03-27	U-3647	Drug product	2023-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208447-001	8071579	2027-08-12	U-2655		2019-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208447-001	8143241	2027-08-12	U-2655		2019-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208447-001	8436185	2029-04-24		Drug substance	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208447-001	8071623	2031-03-27		Drug substance, Drug product	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208447-001	8859562	2031-08-04	U-2655		2019-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208447-001	11091459	2038-03-27		Drug product	2021-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208447-001	11673877	2038-03-27	U-3646	Drug product	2023-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208447-001	11673877	2038-03-27	U-3647	Drug product	2023-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208447-001	8071579	2027-08-12	U-2655		2019-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208447-001	8143241	2027-08-12	U-2655		2019-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208447-001	8436185	2029-04-24		Drug substance	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208447-001	8071623	2031-03-27		Drug substance, Drug product	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208447-001	8859562	2031-08-04	U-2655		2019-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208447-001	11091459	2038-03-27		Drug product	2021-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208447-001	11673877	2038-03-27	U-3646	Drug product	2023-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208447-001	11673877	2038-03-27	U-3647	Drug product	2023-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208447-001	8071579	2027-08-12	U-2655		2019-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208447-001	8143241	2027-08-12	U-2655		2019-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208447-001	8436185	2029-04-24		Drug substance	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208447-001	8071623	2031-03-27		Drug substance, Drug product	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208447-001	8859562	2031-08-04	U-2655		2019-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208447-001	11091459	2038-03-27		Drug product	2021-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208447-001	11673877	2038-03-27	U-3646	Drug product	2023-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208447-001	11673877	2038-03-27	U-3647	Drug product	2023-07-11	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 197 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N208447-001	ODE-277	2026-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208447-001	ODE-295	2027-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208447-001	ODE-277	2026-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208447-001	ODE-295	2027-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208447-001	ODE-277	2026-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208447-001	ODE-295	2027-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208447-001	ODE-277	2026-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208447-001	ODE-295	2027-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208447-001	ODE-277	2026-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208447-001	ODE-295	2027-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208447-001	ODE-277	2026-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208447-001	ODE-295	2027-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208447-001	ODE-133	2024-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208447-001	ODE-277	2026-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208447-001	ODE-295	2027-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208447-001	ODE-133	2024-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208447-001	ODE-277	2026-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208447-001	ODE-295	2027-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208447-001	ODE-133	2024-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208447-001	ODE-277	2026-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208447-001	ODE-295	2027-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208447-001	ODE-133	2024-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208447-001	ODE-277	2026-10-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208447-001	ODE-295	2027-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208447-001	ODE-133	2024-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208447-001	ODE-277	2026-10-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208447-001	ODE-295	2027-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208447-001	ODE-133	2024-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208447-001	ODE-277	2026-10-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208447-001	ODE-295	2027-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208447-001	ODE-133	2024-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208447-001	ODE-277	2026-10-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208447-001	ODE-295	2027-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208447-001	ODE-133	2024-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208447-001	ODE-277	2026-10-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208447-001	ODE-295	2027-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208447-001	ODE-133	2024-03-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208447-001	ODE-277	2026-10-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208447-001	ODE-295	2027-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208447-001	NCE	2022-03-27	`5c6f7cd8ea54…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69656-103-30	EA - Each	69656-103	a1af9cb8-660c-4a4b-b27c-65ed96c52a62	1	2018-08-13
69656-103-90	EA - Each	69656-103	e0e17036-a8a9-4bd2-b21c-42151d0eb3e8	1	2017-05-04

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HMC2H89N35	NIRAPARIB	1038915-60-4	NIRAPARIB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69656-103-30	69656010330	30 CAPSULE in 1 BOTTLE (69656-103-30)	30 capsule	2018-07-01	0000-00-00	No	No	Current
69656-103-61	69656010361	30 CAPSULE in 1 BOTTLE (69656-103-61)	30 capsule	2020-07-01	0000-00-00	Yes	No	Current
69656-103-90	69656010390	90 CAPSULE in 1 BOTTLE (69656-103-90)	90 capsule	2017-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZEJULA	GlaxoSmithKline LLC	2024-05-07	HUMAN PRESCRIPTION DRUG LABEL	26
ZEJULA	TESARO, Inc.	2019-10-28	HUMAN PRESCRIPTION DRUG LABEL	8