Ticagrelor

Product NDC
55488-0543
11-digit product format
554880543
Labeler code
55488
Product ID
55488-0543_79364f10-afa0-4a5f-96d2-f82bcc9cf928
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET
Route
ORAL
Labeler
Changzhou Pharmaceutical Factory
Application
ANDA216187
Marketing category
ANDA
Marketing start
2025-10-28
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55488-0543-1Ticagrelor60 in 1 BOTTLETABLET601
55488-0543-2Ticagrelor500 in 1 BOTTLETABLET5001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666332ticagrelor 60 MG Oral TabletPSN751410c1-452b-400b-a640-d31623a6fda31
1116635ticagrelor 90 MG Oral TabletPSN751410c1-452b-400b-a640-d31623a6fda31
1666332ticagrelor 60 MG Oral TabletSCD751410c1-452b-400b-a640-d31623a6fda31
1116635ticagrelor 90 MG Oral TabletSCD751410c1-452b-400b-a640-d31623a6fda31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55488-0543-15548805430160 TABLET in 1 BOTTLE (55488-0543-1) 60 tablet2025-10-28NoNoHistorical
55488-0543-255488054302500 TABLET in 1 BOTTLE (55488-0543-2) 500 tablet2025-10-28NoNoHistorical