Ticagrelor

Product NDC
33342-432
11-digit product format
333420432
Labeler code
33342
Product ID
33342-432_32769721-c1dd-4bd3-90aa-a6cab59d3cd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA212258
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
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
33342-432-09Ticagrelor60 in 1 BOTTLETABLET, FILM COATED601
33342-432-12Ticagrelor10 in 1 CARTONTABLET, FILM COATED101
33342-432-12Ticagrelor10 in 1 BLISTER PACKTABLET, FILM COATED101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-432-09EA - Each33342-432d7dd727c-9f7f-43b9-a148-41ebe9aaae1312025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666332ticagrelor 60 MG Oral TabletPSN32769721-c1dd-4bd3-90aa-a6cab59d3cd61
1116635ticagrelor 90 MG Oral TabletPSN32769721-c1dd-4bd3-90aa-a6cab59d3cd61
1666332ticagrelor 60 MG Oral TabletSCD32769721-c1dd-4bd3-90aa-a6cab59d3cd61
1116635ticagrelor 90 MG Oral TabletSCD32769721-c1dd-4bd3-90aa-a6cab59d3cd61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-432-093334204320960 TABLET, FILM COATED in 1 BOTTLE (33342-432-09) 2025-10-28NoNoHistorical
33342-432-123334204321210 BLISTER PACK in 1 CARTON (33342-432-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-10-28NoNoHistorical