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
1bbdc202-bbe4-4aec-b4e9-1f1feb41d819
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2024
Manufacturers
FDA
Teva Pharmaceuticals, Inc.
DUNS: 022629579
Products 2
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 Code0480-2695
Application NumberANDA208390
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ticagrelor
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2024
FDA Product Classification
INGREDIENTS (12)
TICAGRELORActive
Quantity: 90 mg in 1 1
Code: GLH0314RVC
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Ticagrelor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-2688
Application NumberANDA208390
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ticagrelor
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2024
FDA Product Classification
INGREDIENTS (12)
TICAGRELORActive
Quantity: 60 mg in 1 1
Code: GLH0314RVC
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT