Lynparza

Product NDC: 0310-0578
11-digit product format: 003100578
Labeler code: 0310
Product ID: 0310-0578_0142c57f-6211-4638-8c48-c215686871b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olaparib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA208558
Marketing category: NDA
Marketing start: 2017-08-17
Substance: OLAPARIB
Active strength: 150 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208558-001	LYNPARZA	OLAPARIB	100MG	TABLET / ORAL		RLD	2017-08-17
N208558-002	LYNPARZA	OLAPARIB	150MG	TABLET / ORAL		RLD, RS	2017-08-17

Orange Book patents#

Current patent rows page 1 of 2 · 114 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208558-001	8071579	2027-08-12	U-2480		2020-06-18
N208558-001	8071579	2027-08-12	U-2482		2020-06-18
N208558-001	8071579	2027-08-12	U-2483		2020-06-18
N208558-001	8071579	2027-08-12	U-2716		2020-06-18
N208558-001	8071579	2027-08-12	U-2819		2020-06-18
N208558-001	8071579	2027-08-12	U-2820		2020-06-18
N208558-001	8071579	2027-08-12	U-2821		2020-06-18
N208558-001	8071579	2027-08-12	U-2822		2020-06-18
N208558-001	8071579	2027-08-12	U-2823		2020-06-18
N208558-001	8071579	2027-08-12	U-2824		2020-06-18
N208558-001	8071579	2027-08-12	U-2832		2020-06-18
N208558-001	8071579	2027-08-12	U-2833		2020-06-18
N208558-001	8071579	2027-08-12	U-3333		2020-06-18
N208558-001	8071579	2027-08-12	U-3631		2020-06-18
N208558-001	8071579	2027-08-12	U-3695		2020-06-18
N208558-001	8143241	2027-08-12	U-2480		2017-09-15
N208558-001	8143241	2027-08-12	U-2482		2017-09-15
N208558-001	8143241	2027-08-12	U-2483		2017-09-15
N208558-001	8143241	2027-08-12	U-2716		2017-09-15
N208558-001	8143241	2027-08-12	U-2819		2017-09-15
N208558-001	8143241	2027-08-12	U-2820		2017-09-15
N208558-001	8143241	2027-08-12	U-2821		2017-09-15
N208558-001	8143241	2027-08-12	U-2822		2017-09-15
N208558-001	8143241	2027-08-12	U-2823		2017-09-15
N208558-001	8143241	2027-08-12	U-2824		2017-09-15
N208558-001	8143241	2027-08-12	U-2832		2017-09-15
N208558-001	8143241	2027-08-12	U-2833		2017-09-15
N208558-001	8143241	2027-08-12	U-3333		2017-09-15
N208558-001	8143241	2027-08-12	U-3631		2017-09-15
N208558-001	8143241	2027-08-12	U-3695		2017-09-15
N208558-001	7449464	2027-09-08		Drug substance, Drug product	2017-09-15
N208558-001	11633396	2029-10-07		Drug product	2023-05-19
N208558-001	11975001	2029-10-07		Drug product	2024-06-03
N208558-001	12048695	2029-10-07		Drug product	2024-08-23
N208558-001	12144810	2029-10-07		Drug product	2024-12-10
N208558-001	12178816	2029-10-07		Drug product	2025-01-24
N208558-001	8475842	2029-12-31		Drug product	2017-09-15
N208558-001	8859562	2031-08-04	U-2101		2017-09-15
N208558-001	8859562	2031-08-04	U-2103		2017-09-15
N208558-001	8859562	2031-08-04	U-2480		2017-09-15
N208558-001	8859562	2031-08-04	U-2482		2017-09-15
N208558-001	8859562	2031-08-04	U-2483		2017-09-15
N208558-001	8859562	2031-08-04	U-2716		2017-09-15
N208558-001	8859562	2031-08-04	U-2819		2017-09-15
N208558-001	8859562	2031-08-04	U-2820		2017-09-15
N208558-001	8859562	2031-08-04	U-2821		2017-09-15
N208558-001	8859562	2031-08-04	U-2822		2017-09-15
N208558-001	8859562	2031-08-04	U-2823		2017-09-15
N208558-001	8859562	2031-08-04	U-2824		2017-09-15
N208558-001	8859562	2031-08-04	U-2832		2017-09-15
N208558-001	8859562	2031-08-04	U-2833		2017-09-15
N208558-001	8859562	2031-08-04	U-3333		2017-09-15
N208558-001	8859562	2031-08-04	U-3631		2017-09-15
N208558-001	8859562	2031-08-04	U-3695		2017-09-15
N208558-001	11970530	2041-10-25	U-3929		2024-05-28
N208558-001	11970530	2041-10-25	U-3930		2024-05-28
N208558-001	11970530	2041-10-25	U-3931		2024-05-28
N208558-002	8071579	2027-08-12	U-2480		2020-06-18
N208558-002	8071579	2027-08-12	U-2482		2020-06-18
N208558-002	8071579	2027-08-12	U-2483		2020-06-18
N208558-002	8071579	2027-08-12	U-2716		2020-06-18
N208558-002	8071579	2027-08-12	U-2819		2020-06-18
N208558-002	8071579	2027-08-12	U-2820		2020-06-18
N208558-002	8071579	2027-08-12	U-2821		2020-06-18
N208558-002	8071579	2027-08-12	U-2822		2020-06-18
N208558-002	8071579	2027-08-12	U-2823		2020-06-18
N208558-002	8071579	2027-08-12	U-2824		2020-06-18
N208558-002	8071579	2027-08-12	U-2832		2020-06-18
N208558-002	8071579	2027-08-12	U-2833		2020-06-18
N208558-002	8071579	2027-08-12	U-3333		2020-06-18
N208558-002	8071579	2027-08-12	U-3631		2020-06-18
N208558-002	8071579	2027-08-12	U-3695		2020-06-18
N208558-002	8143241	2027-08-12	U-2480		2017-09-15
N208558-002	8143241	2027-08-12	U-2482		2017-09-15
N208558-002	8143241	2027-08-12	U-2483		2017-09-15
N208558-002	8143241	2027-08-12	U-2716		2017-09-15
N208558-002	8143241	2027-08-12	U-2819		2017-09-15
N208558-002	8143241	2027-08-12	U-2820		2017-09-15
N208558-002	8143241	2027-08-12	U-2821		2017-09-15
N208558-002	8143241	2027-08-12	U-2822		2017-09-15

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208558-001	I-914	2026-05-31
N208558-001	ODE-283	2026-12-27
N208558-001	ODE-306	2027-05-08
N208558-002	I-914	2026-05-31
N208558-002	ODE-283	2026-12-27
N208558-002	ODE-306	2027-05-08

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 3 · 82 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	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 123 · 4,893 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	N208558-001	8071579	2027-08-12	U-3631		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2716		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2483		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2482		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-3695		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2820		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2824		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2833		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2823		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2832		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2480		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2821		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2819		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2822		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-3333		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2482		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2480		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2716		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2483		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-3631		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2824		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2823		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2821		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2819		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2820		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2822		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-3695		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2832		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2833		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-3333		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	7449464	2027-09-08		Drug substance, Drug product	2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	11633396	2029-10-07		Drug product	2023-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	11975001	2029-10-07		Drug product	2024-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	12048695	2029-10-07		Drug product	2024-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	12144810	2029-10-07		Drug product	2024-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	12178816	2029-10-07		Drug product	2025-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8475842	2029-12-31		Drug product	2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8859562	2031-08-04	U-2101		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8859562	2031-08-04	U-2483		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8859562	2031-08-04	U-2482		2017-09-15	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 17 · 644 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208558-001	I-914	2026-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	ODE-283	2026-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	ODE-306	2027-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-002	I-914	2026-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-002	ODE-283	2026-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-002	ODE-306	2027-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-001	I-885	2025-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-001	ODE-226	2025-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-001	I-914	2026-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-001	ODE-283	2026-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-001	ODE-306	2027-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-002	I-885	2025-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-002	ODE-226	2025-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-002	I-914	2026-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-002	ODE-283	2026-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-002	ODE-306	2027-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208558-001	I-885	2025-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-001	ODE-226	2025-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-001	I-914	2026-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-001	ODE-283	2026-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-001	ODE-306	2027-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-002	I-885	2025-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-002	ODE-226	2025-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-002	I-914	2026-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-002	ODE-283	2026-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-002	ODE-306	2027-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-001	I-885	2025-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-001	ODE-226	2025-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-001	I-914	2026-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-001	ODE-283	2026-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-001	ODE-306	2027-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-002	I-885	2025-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-002	ODE-226	2025-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-002	I-914	2026-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-002	ODE-283	2026-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-002	ODE-306	2027-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208558-001	I-885	2025-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208558-001	ODE-226	2025-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208558-001	I-914	2026-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208558-001	ODE-283	2026-12-27	`b8a1b40f171c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLAPARIB	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WOH1JD9AR8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1942482	Internal RxNorm lookup
1942485	Internal RxNorm lookup
1942487	Internal RxNorm lookup
1942489	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
741ff3e3-dc1a-45a6-84e5-2481b27131aa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8aca7953-121c-4bc4-bc4b-c3dea9d035ed	Product name	1	20171006
74743eac-fb51-4dac-af6a-4c1391f918c9	Product name	1	20150225

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0310-0578-12	Lynparza	120 in 1 BOTTLE	TABLET, FILM COATED	120		38
0310-0578-60	Lynparza	60 in 1 BOTTLE	TABLET, FILM COATED	60		38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-0578-12	EA - Each	0310-0578	acced4b6-0b48-46a0-9928-25260383fe2f	1	2025-03-04
0310-0578-60	EA - Each	0310-0578	ccc5bbd5-a6fa-479d-b0e5-2b598e0bbb31	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0310-0578	LYNPARZA (OLAPARIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	37	Current NDC, 2 package rows	20250223_741ff3e3-dc1a-45a6-84e5-2481b27131aa.zip

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
Lynparza	OLAPARIB	AstraZeneca Pharmaceuticals LP	741ff3e3-dc1a-45a6-84e5-2481b27131aa	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208558 application number: NDA208558 ndc (product): 0310-0578

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WOH1JD9AR8	OLAPARIB	763113-22-0	OLAPARIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1942485	Lynparza 100 MG Oral Tablet	PSN	741ff3e3-dc1a-45a6-84e5-2481b27131aa	38
1942489	Lynparza 150 MG Oral Tablet	PSN	741ff3e3-dc1a-45a6-84e5-2481b27131aa	38
1942482	olaparib 100 MG Oral Tablet	PSN	741ff3e3-dc1a-45a6-84e5-2481b27131aa	38
1942487	olaparib 150 MG Oral Tablet	PSN	741ff3e3-dc1a-45a6-84e5-2481b27131aa	38
1942485	olaparib 100 MG Oral Tablet [Lynparza]	SBD	741ff3e3-dc1a-45a6-84e5-2481b27131aa	38
1942489	olaparib 150 MG Oral Tablet [Lynparza]	SBD	741ff3e3-dc1a-45a6-84e5-2481b27131aa	38
1942482	olaparib 100 MG Oral Tablet	SCD	741ff3e3-dc1a-45a6-84e5-2481b27131aa	38
1942487	olaparib 150 MG Oral Tablet	SCD	741ff3e3-dc1a-45a6-84e5-2481b27131aa	38
1942485	Lynparza 100 MG Oral Tablet	SY	741ff3e3-dc1a-45a6-84e5-2481b27131aa	38
1942489	Lynparza 150 MG Oral Tablet	SY	741ff3e3-dc1a-45a6-84e5-2481b27131aa	38

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0310-0578-12	00310057812	120 TABLET, FILM COATED in 1 BOTTLE (0310-0578-12)	2025-02-20	No	No	Current
0310-0578-60	00310057860	60 TABLET, FILM COATED in 1 BOTTLE (0310-0578-60)	2025-02-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lynparza	AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	2025-07-10	HUMAN PRESCRIPTION DRUG LABEL	38