Ticagrelor

Product NDC
72516-018
11-digit product format
725160018
Labeler code
72516
Product ID
72516-018_32c950ec-054d-b0f7-e063-6394a90ad41c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET
Route
ORAL
Labeler
Oryza Pharmaceuticals, Inc.
Application
ANDA208508
Marketing category
ANDA
Marketing start
2025-04-15
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TICAGRELOR90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGLH0314RVC
Rxcui1116635

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2b3fae0e-1168-2920-6fac-e67420589ce0Product name920260113
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72516-018-06Ticagrelor60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72516-018-06EA - Each72516-0183ff8a3c5-43b4-44c9-abf2-ed3d8bff8fa312026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72516-018TICAGRELOR TABLET [ORYZA PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20250419_32c950bd-7f5f-a811-e063-6394a90a0080.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116635ticagrelor 90 MG Oral TabletPSN32c950bd-7f5f-a811-e063-6394a90a00801
1116635ticagrelor 90 MG Oral TabletSCD32c950bd-7f5f-a811-e063-6394a90a00801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72516-018-067251600180660 TABLET in 1 BOTTLE (72516-018-06) 60 tablet2025-04-15YesNoHistorical