Ticagrelor

Product NDC: 67877-491
11-digit product format: 678770491
Labeler code: 67877
Product ID: 67877-491_d7f89cc8-6226-4caa-b8ee-22155683489c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ticagrelor
Dosage form: TABLET
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA208567
Marketing category: ANDA
Marketing start: 2025-04-30
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 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
A208567-001	TICAGRELOR	TICAGRELOR	90MG	TABLET / ORAL	AB		2023-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208567-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208567-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2023-04-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208567-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208567-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208567-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208567-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208567-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208567-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208567-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208567-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208567-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208567-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208567-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208567-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208567-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208567-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208567-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208567-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208567-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208567-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208567-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208567-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208567-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208567-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208567-001	AB	1	`a50c72e98297…`

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
2f73a4db-2c7f-4e42-a914-87aedc2780fb	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
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	Strength	SPL version
67877-491-05	Ticagrelor	500 in 1 BOTTLE	TABLET	500		19
67877-491-60	Ticagrelor	60 in 1 BOTTLE	TABLET	60		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-491-05	EA - Each	67877-491	3e01061c-5523-4472-b52f-0260a387b8dd	1	2026-04-20
67877-491-60	EA - Each	67877-491	e1b480cc-739d-43a3-8420-42ea40a44213	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-491	TICAGRELOR TABLET [ASCEND LABORATORIES, LLC]	16	Current NDC, 2 package rows	20250430_2f73a4db-2c7f-4e42-a914-87aedc2780fb.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
Ticagrelor	TICAGRELOR	Ascend Laboratories, LLC	2f73a4db-2c7f-4e42-a914-87aedc2780fb	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208567 application number: ANDA208567 ndc (product): 67877-491

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
1116635	ticagrelor 90 MG Oral Tablet	PSN	2f73a4db-2c7f-4e42-a914-87aedc2780fb	19
1116635	ticagrelor 90 MG Oral Tablet	SCD	2f73a4db-2c7f-4e42-a914-87aedc2780fb	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67877-491-05	67877049105	500 TABLET in 1 BOTTLE (67877-491-05)	500 tablet	2026-03-05	No	No	Current
67877-491-60	67877049160	60 TABLET in 1 BOTTLE (67877-491-60)	60 tablet	2025-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ticagrelor	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2026-05-22	Human Prescription Drug Label	19