NDC 55154-9618

BRILINTA

Ticagrelor

BRILINTA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health. The primary component is Ticagrelor.

Product ID55154-9618_00b96008-1f1b-4704-992f-9ffb57d89f9d
NDC55154-9618
Product TypeHuman Prescription Drug
Proprietary NameBRILINTA
Generic NameTicagrelor
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-08-05
Marketing CategoryNDA / NDA
Application NumberNDA022433
Labeler NameCardinal Health
Substance NameTICAGRELOR
Active Ingredient Strength90 mg/1
Pharm ClassesP2Y12 Platelet Inhibitor [EPC],Phenylalanine Hydroxylase Activators [MoA],Decreased Platelet Aggregation [PE],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55154-9618-0

10 BLISTER PACK in 1 BAG (55154-9618-0) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2011-08-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55154-9618-8 [55154961808]

BRILINTA TABLET
Marketing CategoryNDA
Application NumberNDA022433
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-05

NDC 55154-9618-0 [55154961800]

BRILINTA TABLET
Marketing CategoryNDA
Application NumberNDA022433
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-05

Drug Details

Active Ingredients

IngredientStrength
TICAGRELOR90 mg/1

OpenFDA Data

SPL SET ID:4f9bd52a-99a7-4606-92b4-456a917aabef
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1116635
  • 1116639
  • UPC Code
  • 0055154961806
  • Pharmacological Class

    • P2Y12 Platelet Inhibitor [EPC]
    • Phenylalanine Hydroxylase Activators [MoA]
    • Decreased Platelet Aggregation [PE]
    • P2Y12 Receptor Antagonists [MoA]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 3A5 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]

    NDC Crossover Matching brand name "BRILINTA" or generic name "Ticagrelor"

    NDCBrand NameGeneric Name
    0186-0776BRILINTATicagrelor
    0186-0777BRILINTATicagrelor
    55154-9618BRILINTATicagrelor
    69238-1134ticagrelorticagrelor

    Trademark Results [BRILINTA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BRILINTA
    BRILINTA
    78457162 3040606 Live/Registered
    AstraZeneca AB
    2004-07-27

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.