ticagrelor

Product NDC
50228-522
11-digit product format
502280522
Labeler code
50228
Product ID
50228-522_3d85dd4c-b57c-44f8-bb8f-c3f04545c09d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ticagrelor
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals INC
Application
ANDA218962
Marketing category
ANDA
Marketing start
2025-10-09
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, 1666332

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
50228-522-10ticagrelor1000 in 1 BOTTLETABLET10003
50228-522-30ticagrelor30 in 1 BOTTLETABLET303
50228-522-60ticagrelor60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-522-60EA - Each50228-5220be98f44-3284-463b-974e-8e16d0765c3a12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666332ticagrelor 60 MG Oral TabletPSN40ac26dc-2570-de7e-e063-6294a90ade723
1116635ticagrelor 90 MG Oral TabletPSN40ac26dc-2570-de7e-e063-6294a90ade723
1666332ticagrelor 60 MG Oral TabletSCD40ac26dc-2570-de7e-e063-6294a90ade723
1116635ticagrelor 90 MG Oral TabletSCD40ac26dc-2570-de7e-e063-6294a90ade723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50228-522-10502280522101000 TABLET in 1 BOTTLE (50228-522-10) 1000 tablet2025-10-09NoNoHistorical
50228-522-305022805223030 TABLET in 1 BOTTLE (50228-522-30) 30 tablet2025-10-09NoNoHistorical
50228-522-605022805226060 TABLET in 1 BOTTLE (50228-522-60) 60 tablet2025-10-09NoNoHistorical