Ticagrelor

Product NDC: 69097-989
Requested package NDC: 69097-989-03
11-digit product format: 690970989
Labeler code: 69097
Product ID: 69097-989_d431b0b1-c7f9-40e4-9a30-6e778dcdde8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ticagrelor
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA208537
Marketing category: ANDA
Marketing start: 2025-10-29
Substance: TICAGRELOR
Active strength: 60 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
A208537-001	TICAGRELOR	TICAGRELOR	90MG	TABLET / ORAL	AB		2025-05-05
A208537-002	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
A208537-001	AB
A208537-002	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	A208537-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2025-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208537-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208537-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2025-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208537-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208537-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2025-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208537-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208537-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2025-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208537-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208537-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2025-05-05	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208537-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2025-05-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208537-002	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	A208537-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208537-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208537-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208537-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208537-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208537-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208537-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208537-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208537-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208537-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208537-002	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	60 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1116635	Internal RxNorm lookup
1666332	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
789606e3-9efa-440c-84f1-f1c56fcbf0cd	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69097-989-03	Ticagrelor	60 in 1 PACKAGE	TABLET, FILM COATED	60	2
69097-989-07	Ticagrelor	100 in 1 PACKAGE	TABLET, FILM COATED	100	2
69097-989-12	Ticagrelor	500 in 1 PACKAGE	TABLET, FILM COATED	500	2

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	Aphena Pharma Solutions - Tennessee, LLC	37b2d081-c17a-c126-e063-6394a90a5729	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208537 application number: ANDA208537
TICAGRELOR	TICAGRELOR	Exelan Pharmaceuticals, Inc	eb8fb960-1f0e-40b1-9889-b02296bb3c37	2025-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208537 application number: ANDA208537
Ticagrelor	TICAGRELOR	Cipla USA Inc.	789606e3-9efa-440c-84f1-f1c56fcbf0cd	2025-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208537 application number: ANDA208537 ndc (package): 69097-989-03 ndc (product): 69097-989 ndc11 (package): 69097098903

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
1666332	ticagrelor 60 MG Oral Tablet	PSN	789606e3-9efa-440c-84f1-f1c56fcbf0cd	2
1116635	ticagrelor 90 MG Oral Tablet	PSN	789606e3-9efa-440c-84f1-f1c56fcbf0cd	2
1666332	ticagrelor 60 MG Oral Tablet	SCD	789606e3-9efa-440c-84f1-f1c56fcbf0cd	2
1116635	ticagrelor 90 MG Oral Tablet	SCD	789606e3-9efa-440c-84f1-f1c56fcbf0cd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69097-989-03	69097098903	60 TABLET, FILM COATED in 1 PACKAGE (69097-989-03)	2025-10-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ticagrelor	Cipla USA Inc. \| InvaGen Pharmaceuticals, Inc.	2025-03-01	HUMAN PRESCRIPTION DRUG LABEL	2