Ticagrelor

Product NDC
69097-989
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TICAGRELOR60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGLH0314RVC
Rxcui1116635, 1666332

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2b3fae0e-1168-2920-6fac-e67420589ce0Product name920260113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-989-03Ticagrelor60 in 1 PACKAGETABLET, FILM COATED602
69097-989-07Ticagrelor100 in 1 PACKAGETABLET, FILM COATED1002
69097-989-12Ticagrelor500 in 1 PACKAGETABLET, FILM COATED5002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666332ticagrelor 60 MG Oral TabletPSN789606e3-9efa-440c-84f1-f1c56fcbf0cd2
1116635ticagrelor 90 MG Oral TabletPSN789606e3-9efa-440c-84f1-f1c56fcbf0cd2
1666332ticagrelor 60 MG Oral TabletSCD789606e3-9efa-440c-84f1-f1c56fcbf0cd2
1116635ticagrelor 90 MG Oral TabletSCD789606e3-9efa-440c-84f1-f1c56fcbf0cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69097-989-036909709890360 TABLET, FILM COATED in 1 PACKAGE (69097-989-03) 2025-10-29NoNoHistorical
69097-989-0769097098907100 TABLET, FILM COATED in 1 PACKAGE (69097-989-07) 2025-10-29NoNoHistorical
69097-989-1269097098912500 TABLET, FILM COATED in 1 PACKAGE (69097-989-12) 2025-10-29NoNoHistorical