TICAGRELOR

Product NDC: 53401-028
11-digit product format: 534010028
Labeler code: 53401
Product ID: 53401-028_5955a587-d699-8ec7-e063-6394a90ab517
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TICAGRELOR
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA208596
Marketing category: ANDA
Marketing start: 2025-04-24
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208596-001	TICAGRELOR	TICAGRELOR	90MG	TABLET / ORAL	AB		2020-04-07
A208596-002	TICAGRELOR	TICAGRELOR	60MG	TABLET / ORAL	AB		2025-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208596-001	AB
A208596-002	AB

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208596-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2020-04-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208596-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208596-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2020-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208596-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208596-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2020-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208596-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208596-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2020-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208596-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208596-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2020-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208596-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2020-04-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208596-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2020-04-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208596-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2020-04-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208596-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2020-04-07	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208596-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208596-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208596-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208596-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208596-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208596-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208596-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208596-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208596-001	AB	1	`6a471c1ec25d…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208596-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208596-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208596-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208596-001	AB	1	`c0c555d07b60…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208596-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208596-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: TICAGRELOR
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1116635	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
5955a5f5-fbc7-8f67-e063-6394a90ada36	Available on FDA.report

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TICAGRELOR	TICAGRELOR	Aphena Pharma Solutions - Tennessee, LLC	5955a5f5-fbc7-8f67-e063-6394a90ada36	2026-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208596 application number: ANDA208596 ndc (product): 53401-028
TICAGRELOR	TICAGRELOR	Novadoz Pharmaceuticals LLC	b1c29d47-960f-4fc4-b6ff-399e2c6eec4c	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208596 application number: ANDA208596
Ticagrelor	TICAGRELOR	American Health Packaging	a50eb0b4-1bee-4781-8eba-75e324540d36	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208596 application number: ANDA208596
TICAGRELOR	TICAGRELOR	AvPAK	425024ab-e092-7a6d-e063-6294a90ae4f3	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208596 application number: ANDA208596
TICAGRELOR	TICAGRELOR	AvKARE	40bb0fb0-2275-4df7-e063-6394a90ade2e	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208596 application number: ANDA208596
TICAGRELOR	TICAGRELOR	AvKARE	32ebf046-73e4-b11b-e063-6294a90a5bf4	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208596 application number: ANDA208596

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53401-028-42	53401002842	1800 TABLET in 1 BOTTLE (53401-028-42)	1800 tablet	2026-08-17	No	No	Current