Ticagrelor
These highlights do not include all the information needed to use TICAGRELOR TABLETS safely and effectively. See full prescribing information for TICAGRELOR TABLETS. TICAGRELOR tablets, for oral use Initial U.S. Approval: 2011
Approved
Approval ID
2f73a4db-2c7f-4e42-a914-87aedc2780fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2025
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ticagrelor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-491
Application NumberANDA208567
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ticagrelor
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2025
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TICAGRELORActive
Quantity: 90 mg in 1 1
Code: GLH0314RVC
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT