BRILINTA

Product NDC: 0186-0777
11-digit product format: 001860777
Labeler code: 0186
Product ID: 0186-0777_5e8e6357-e223-4acf-870d-829e251fba6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ticagrelor
Dosage form: TABLET
Route: ORAL
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA022433
Marketing category: NDA
Marketing start: 2011-08-05
Substance: TICAGRELOR
Active strength: 90 mg/1
Pharmacologic classes: Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 package	package	0186-0777	0186-0777-08	D	Discontinued by firm	2026-08-03
excluded package	package	0186-0777	0186-0777-18	D	Discontinued by firm	2026-08-03
excluded package	package	0186-0777	0186-0777-28	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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0186-0777-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0186-0777-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0186-0777-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0186-0777-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0186-0777-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0186-0777-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0186-0777-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0186-0777-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0186-0777-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0186-0777-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0186-0777-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0186-0777-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0186-0777-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0186-0777-28	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0186-0777-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0186-0777-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0186-0777-18	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0186-0777-28	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0186-0777-18	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0186-0777-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0186-0777-18	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0186-0777-28	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0186-0777-18	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0186-0777-28	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N022433-001	BRILINTA	TICAGRELOR	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20
N022433-002	BRILINTA	TICAGRELOR	60MG	TABLET / ORAL	AB	RLD	2015-09-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022433-001	AB
N022433-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022433-001	8425934	2030-04-17		Drug product	2013-05-20
N022433-001	8425934*PED	2030-10-17		Pediatric extension
N022433-001	10300065	2036-01-27	U-2541		2019-06-24
N022433-001	10300065	2036-01-27	U-2542		2019-06-24
N022433-001	10300065*PED	2036-07-27		Pediatric extension
N022433-002	8425934	2030-04-17		Drug product	2015-09-30
N022433-002	8425934*PED	2030-10-17		Pediatric extension
N022433-002	10300065	2036-01-27	U-2541		2019-06-24
N022433-002	10300065	2036-01-27	U-2542		2019-06-24
N022433-002	10300065*PED	2036-07-27		Pediatric extension

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	BRILINTA	60MG	TABLET / ORAL	AB	RLD	2015-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	BRILINTA	60MG	TABLET / ORAL	AB	RLD	2015-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-002	BRILINTA	60MG	TABLET / ORAL	AB	RLD	2015-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022433-002	BRILINTA	60MG	TABLET / ORAL	AB	RLD	2015-09-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022433-002	BRILINTA	60MG	TABLET / ORAL	AB	RLD	2015-09-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022433-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022433-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022433-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022433-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022433-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022433-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022433-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022433-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022433-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022433-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022433-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022433-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022433-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022433-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022433-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022433-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022433-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022433-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022433-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022433-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022433-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022433-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022433-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022433-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022433-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022433-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022433-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022433-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022433-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022433-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022433-001	AB	1	`053a50430f4f…`

Observed Orange Book patent history#

Patent history page 1 of 27 · 1,050 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	N022433-001	8425934	2030-04-17		Drug product	2013-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-001	8425934*PED	2030-10-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-001	10300065	2036-01-27	U-2541		2019-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-001	10300065	2036-01-27	U-2542		2019-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-001	10300065*PED	2036-07-27		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	8425934	2030-04-17		Drug product	2015-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	8425934*PED	2030-10-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	10300065	2036-01-27	U-2541		2019-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	10300065	2036-01-27	U-2542		2019-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	10300065*PED	2036-07-27		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-1936	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-1935	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-1937	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-1938	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-2988	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-2839	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-2838	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276*PED	2025-04-30		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	8425934	2030-04-17		Drug product	2013-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	8425934*PED	2030-10-17		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	10300065	2036-01-27	U-2541		2019-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	10300065	2036-01-27	U-2542		2019-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	10300065*PED	2036-07-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-1935	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-1938	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-1936	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-1937	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-2988	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-2839	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-2838	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276*PED	2025-04-30		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	8425934	2030-04-17		Drug product	2015-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	8425934*PED	2030-10-17		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	10300065	2036-01-27	U-2541		2019-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	10300065	2036-01-27	U-2542		2019-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	10300065*PED	2036-07-27		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022433-001	RE46276*PED	2025-04-30		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-001	8425934	2030-04-17		Drug product	2013-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-001	8425934*PED	2030-10-17		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-001	10300065	2036-01-27	U-2541		2019-06-24	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 248 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	N022433-001	M-283	2025-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	PED	2025-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	M-283	2025-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	PED	2025-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022433-001	M-283	2025-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-001	PED	2025-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-002	M-283	2025-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-002	PED	2025-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-001	M-283	2025-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-001	PED	2025-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-002	M-283	2025-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-002	PED	2025-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-001	M-283	2025-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-001	PED	2025-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-002	M-283	2025-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-002	PED	2025-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-001	I-848	2023-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-001	PED	2024-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-001	M-283	2025-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-001	PED	2025-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-002	I-848	2023-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-002	PED	2024-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-002	M-283	2025-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-002	PED	2025-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-001	I-848	2023-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-001	PED	2024-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-001	M-283	2025-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-001	PED	2025-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-002	I-848	2023-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-002	PED	2024-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-002	M-283	2025-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-002	PED	2025-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-001	I-848	2023-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-001	PED	2024-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-001	M-283	2025-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-001	PED	2025-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-002	I-848	2023-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-002	PED	2024-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-002	M-283	2025-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-002	PED	2025-11-09	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: BRILINTA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TICAGRELOR	90 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GLH0314RVC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1116635	Internal RxNorm lookup
1116639	Internal RxNorm lookup
1666332	Internal RxNorm lookup
1666334	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
f7b3f443-e83d-4bf2-0e96-023448fed9a8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2b3fae0e-1168-2920-6fac-e67420589ce0	Product name	9	20260113
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0186-0777-08	BRILINTA	8 in 1 BOTTLE	TABLET	8	55
0186-0777-18	BRILINTA	180 in 1 BOTTLE	TABLET	180	55
0186-0777-28	BRILINTA	14 in 1 BOTTLE	TABLET	14	55
0186-0777-39	BRILINTA	10 in 1 BOX, UNIT-DOSE	TABLET	10	55
0186-0777-39	BRILINTA	10 in 1 BLISTER PACK	TABLET	10	55
0186-0777-60	BRILINTA	60 in 1 BOTTLE	TABLET	60	55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0186-0777-28	EA - Each	0186-0777	3dd41657-735a-4995-b50c-ee81e22c7fb8	1	2013-10-17
0186-0777-39	EA - Each	0186-0777	73f49498-c8e3-4fdd-870e-39ae40910f83	1	2012-07-24
0186-0777-60	EA - Each	0186-0777	e2210fdf-4ea2-40ff-aae5-91634b39aeba	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TICAGRELOR	ACTIVE INGREDIENT	GLH0314RVC	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
TICAGRELOR	ACTIVE MOIETY	GLH0314RVC	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
WATER	INACTIVE INGREDIENT	059QF0KO0R	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]	23
TICAGRELOR	ACTIVE INGREDIENT	GLH0314RVC	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2
TICAGRELOR	ACTIVE MOIETY	GLH0314RVC	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0186-0777	BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA PHARMACEUTICALS LP]	53	Current NDC, Legacy NDC, 6 package rows	20241116_f7b3f443-e83d-4bf2-0e96-023448fed9a8.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRILINTA	TICAGRELOR	AstraZeneca Pharmaceuticals LP	f7b3f443-e83d-4bf2-0e96-023448fed9a8	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022433 application number: NDA022433 ndc (product): 0186-0777
BRILINTA	TICAGRELOR	Cardinal Health 107, LLC	4f9bd52a-99a7-4606-92b4-456a917aabef	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022433 application number: NDA022433
BRILINTA	TICAGRELOR	Aphena Pharma Solutions - Tennessee, LLC	1547e2b6-8858-178e-e063-6394a90abb23	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022433 application number: NDA022433

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GLH0314RVC	TICAGRELOR	274693-27-5	TICAGRELOR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1666334	BRILINTA (ticagrelor) 60 MG Oral Tablet	PSN	f7b3f443-e83d-4bf2-0e96-023448fed9a8	55
1116639	BRILINTA (ticagrelor) 90 MG Oral Tablet	PSN	f7b3f443-e83d-4bf2-0e96-023448fed9a8	55
1666332	ticagrelor 60 MG Oral Tablet	PSN	f7b3f443-e83d-4bf2-0e96-023448fed9a8	55
1116635	ticagrelor 90 MG Oral Tablet	PSN	f7b3f443-e83d-4bf2-0e96-023448fed9a8	55
1666334	ticagrelor 60 MG Oral Tablet [Brilinta]	SBD	f7b3f443-e83d-4bf2-0e96-023448fed9a8	55
1116639	ticagrelor 90 MG Oral Tablet [Brilinta]	SBD	f7b3f443-e83d-4bf2-0e96-023448fed9a8	55
1666332	ticagrelor 60 MG Oral Tablet	SCD	f7b3f443-e83d-4bf2-0e96-023448fed9a8	55
1116635	ticagrelor 90 MG Oral Tablet	SCD	f7b3f443-e83d-4bf2-0e96-023448fed9a8	55
1666334	Brilinta 60 MG Oral Tablet	SY	f7b3f443-e83d-4bf2-0e96-023448fed9a8	55
1116639	Brilinta 90 MG Oral Tablet	SY	f7b3f443-e83d-4bf2-0e96-023448fed9a8	55
1116639	BRILINTA (ticagrelor) 90 MG Oral Tablet	PSN	4f9bd52a-99a7-4606-92b4-456a917aabef	19
1116635	ticagrelor 90 MG Oral Tablet	PSN	4f9bd52a-99a7-4606-92b4-456a917aabef	19
1116639	ticagrelor 90 MG Oral Tablet [Brilinta]	SBD	4f9bd52a-99a7-4606-92b4-456a917aabef	19
1116635	ticagrelor 90 MG Oral Tablet	SCD	4f9bd52a-99a7-4606-92b4-456a917aabef	19
1116639	Brilinta 90 MG Oral Tablet	SY	4f9bd52a-99a7-4606-92b4-456a917aabef	19
1116639	BRILINTA (ticagrelor) 90 MG Oral Tablet	PSN	1547e2b6-8858-178e-e063-6394a90abb23	2
1116635	ticagrelor 90 MG Oral Tablet	PSN	1547e2b6-8858-178e-e063-6394a90abb23	2
1116639	ticagrelor 90 MG Oral Tablet [Brilinta]	SBD	1547e2b6-8858-178e-e063-6394a90abb23	2
1116635	ticagrelor 90 MG Oral Tablet	SCD	1547e2b6-8858-178e-e063-6394a90abb23	2
1116639	Brilinta 90 MG Oral Tablet	SY	1547e2b6-8858-178e-e063-6394a90abb23	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0186-0777-08	00186077708	8 TABLET in 1 BOTTLE (0186-0777-08)	8 tablet	2011-08-05	0000-00-00	Yes	No	Current
0186-0777-18	00186077718	180 in 1 BOTTLE						Historical
0186-0777-28	00186077728	14 in 1 BOTTLE						Historical
0186-0777-39	00186077739	10 BLISTER PACK in 1 BOX, UNIT-DOSE (0186-0777-39) / 10 TABLET in 1 BLISTER PACK	10 blister pack	2011-08-05	0000-00-00	No	No	Current
0186-0777-60	00186077760	60 TABLET in 1 BOTTLE (0186-0777-60)	60 tablet	2011-08-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BRILINTA	AstraZeneca Pharmaceuticals LP	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	55
BRILINTA	Cardinal Health 107, LLC	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	19
BRILINTA	Aphena Pharma Solutions - Tennessee, LLC	2024-04-08	HUMAN PRESCRIPTION DRUG LABEL	2