FDA.reportPublic FDA data

Ticagrelor

Product NDC
70756-048
11-digit product format
707560048
Labeler code
70756
Product ID
70756-048_bb3d8f46-1914-4487-8c24-fd6699e8f993
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA217679
Marketing category
ANDA
Marketing start
2026-02-06
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
2027-12-31
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-048-01Ticagrelor10 in 1 BLISTER PACKTABLET, FILM COATED1010
70756-048-60Ticagrelor60 in 1 BOTTLETABLET, FILM COATED6010
70756-048-99Ticagrelor10 in 1 CARTONTABLET, FILM COATED1010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666332ticagrelor 60 MG Oral TabletPSN7efe86fa-5d19-413a-8b15-e51279b62f3f10
1116635ticagrelor 90 MG Oral TabletPSN7efe86fa-5d19-413a-8b15-e51279b62f3f10
1666332ticagrelor 60 MG Oral TabletSCD7efe86fa-5d19-413a-8b15-e51279b62f3f10
1116635ticagrelor 90 MG Oral TabletSCD7efe86fa-5d19-413a-8b15-e51279b62f3f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-048-017075600480110 in 1 BLISTER PACKHistorical
70756-048-607075600486060 TABLET, FILM COATED in 1 BOTTLE (70756-048-60) 2026-02-06NoNoHistorical
70756-048-997075600489910 BLISTER PACK in 1 CARTON (70756-048-99) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70756-048-01) 10 blister pack2026-02-06NoNoHistorical