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
b1c29d47-960f-4fc4-b6ff-399e2c6eec4c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 5, 2025
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TICAGRELOR
PRODUCT DETAILS
NDC Product Code72205-368
Application NumberANDA208596
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 5, 2025
Generic NameTICAGRELOR
INGREDIENTS (12)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TICAGRELORActive
Quantity: 90 mg in 1 1
Code: GLH0314RVC
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 3/5/2025
BOXED WARNING SECTION
LOINC: 34066-1Updated: 3/5/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 3/5/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 3/5/2025
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 3/5/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 3/5/2025
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 3/5/2025
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 3/5/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 3/5/2025
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 3/5/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 3/5/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 3/5/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 3/5/2025
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 3/5/2025
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 3/5/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 3/5/2025
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 3/5/2025
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 3/5/2025
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 3/5/2025