Ticagrelor

Product NDC
60505-4452
11-digit product format
605054452
Labeler code
60505
Product ID
60505-4452_640ebad3-45ab-9163-21fb-b0f3117cfa82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA208584
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
2026-12-31
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
TICAGRELOR90 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
60505-4452-6Ticagrelor60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4452-6EA - Each60505-4452343ee1b6-7085-48f6-aa4f-4e6abe72012012025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4452TICAGRELOR TABLET [APOTEX CORP.]1Current NDC, 1 package rows20250502_2c59ea45-6113-6e9e-70b5-3b8c8b3d89b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666332ticagrelor 60 MG Oral TabletPSN2c59ea45-6113-6e9e-70b5-3b8c8b3d89b62
1116635ticagrelor 90 MG Oral TabletPSN2c59ea45-6113-6e9e-70b5-3b8c8b3d89b62
1116635ticagrelor 90 MG Oral TabletPSN37f1d3d7-030f-180a-e063-6294a90a89da2
1666332ticagrelor 60 MG Oral TabletSCD2c59ea45-6113-6e9e-70b5-3b8c8b3d89b62
1116635ticagrelor 90 MG Oral TabletSCD2c59ea45-6113-6e9e-70b5-3b8c8b3d89b62
1116635ticagrelor 90 MG Oral TabletSCD37f1d3d7-030f-180a-e063-6294a90a89da2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-4452-66050544520660 TABLET in 1 BOTTLE (60505-4452-6) 60 tablet2025-05-01NoNoHistorical