Ticagrelor

Product NDC: 67296-2268
Requested package NDC: 67296-2268-6
11-digit product format: 672962268
Labeler code: 67296
Product ID: 67296-2268_5a66211c-c575-e6e6-e063-6294a90a0a79
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ticagrelor
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA208576
Marketing category: ANDA
Marketing start: 2025-05-01
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
A208576-001	TICAGRELOR	TICAGRELOR	90MG	TABLET / ORAL	AB		2025-05-01
A208576-002	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
A208576-001	AB
A208576-002	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.

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	A208576-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2025-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208576-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208576-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2025-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208576-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208576-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2025-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208576-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208576-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2025-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208576-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208576-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2025-05-01	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208576-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2025-05-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208576-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`a50c72e98297…`

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	A208576-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208576-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208576-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208576-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208576-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208576-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208576-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208576-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208576-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208576-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208576-002	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
557351f1-47b7-216d-e063-6394a90afb51	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ticagrelor	TICAGRELOR	Redpharm Drug	557351f1-47b7-216d-e063-6394a90afb51	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208576 application number: ANDA208576 ndc (package): 67296-2268-6 ndc (product): 67296-2268 ndc11 (package): 67296226806
Ticagrelor	TICAGRELOR	Alembic Pharmaceuticals Inc.	d68b79ab-3104-410e-a63f-9919a23625af	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208576 application number: ANDA208576
Ticagrelor	TICAGRELOR	Alembic Pharmaceuticals Limited	82f66384-e2c7-41c5-961f-384918ef58ec	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208576 application number: ANDA208576

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	Marketing start	Sample	Exclude flag	Status
67296-2268-6	67296226806	60 TABLET, FILM COATED in 1 BOTTLE (67296-2268-6)	2025-05-01	No	No	Current