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
32c950bd-7f5f-a811-e063-6394a90a0080
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2025
Manufacturers
FDA
Oryza Pharmaceuticals, Inc.
DUNS: 080337493
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 Code72516-018
Application NumberANDA208508
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ticagrelor
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TICAGRELORActive
Quantity: 90 mg in 1 1
Code: GLH0314RVC
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/1/2025
BOXED WARNING SECTION
LOINC: 34066-1Updated: 7/31/2024
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 7/31/2024
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 7/31/2024
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 7/31/2024
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 7/31/2024
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 7/31/2024
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 7/31/2024
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 7/31/2024
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 7/31/2024
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 4/1/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/1/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/1/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/1/2025
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 4/1/2025
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 4/1/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/1/2025
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 4/1/2025
SPL MEDGUIDE SECTION
LOINC: 42231-1Updated: 4/1/2025