NDC 54092-606

Xiidra

Lifitegrast

Xiidra is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Lifitegrast.

Product ID54092-606_2648ebbb-5b5e-4497-adc2-db90088ba884
NDC54092-606
Product TypeHuman Prescription Drug
Proprietary NameXiidra
Generic NameLifitegrast
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2016-07-11
Marketing End Date2023-03-31
Marketing CategoryNDA / NDA
Application NumberNDA208073
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameLIFITEGRAST
Active Ingredient Strength50 mg/mL
Pharm ClassesLymphocyte Function-Associated Antigen-1 Antagonist [EPC],Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]
NDC Exclude FlagN

Packaging

NDC 54092-606-01

12 POUCH in 1 CARTON (54092-606-01) > 5 AMPULE in 1 POUCH (54092-606-06) > .2 mL in 1 AMPULE
Marketing Start Date2016-07-11
Marketing End Date2023-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-606-07 [54092060607]

Xiidra SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA208073
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-11

NDC 54092-606-04 [54092060604]

Xiidra SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA208073
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-11

NDC 54092-606-06 [54092060606]

Xiidra SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA208073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-11

NDC 54092-606-02 [54092060602]

Xiidra SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA208073
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-11

NDC 54092-606-01 [54092060601]

Xiidra SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA208073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-11

Drug Details

Active Ingredients

IngredientStrength
LIFITEGRAST50 mg/mL

OpenFDA Data

SPL SET ID:ac09d19a-e321-4556-8a5c-66bd27cb6533
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1801835
  • 1801840
  • Pharmacological Class

    • Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]
    • Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]

    Medicade Reported Pricing

    54092060601 XIIDRA 5% EYE DROPS

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Xiidra" or generic name "Lifitegrast"

    NDCBrand NameGeneric Name
    0078-0911XiidraLifitegrast
    54092-606XiidraLifitegrast

    Trademark Results [Xiidra]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XIIDRA
    XIIDRA
    87319276 5271076 Live/Registered
    SARcode Bioscience Inc.
    2017-01-31
    XIIDRA
    XIIDRA
    86056637 5050074 Live/Registered
    SARcode Bioscience Inc.
    2013-09-05
    XIIDRA
    XIIDRA
    79293316 not registered Live/Pending
    NOVARTIS AG
    2020-06-29

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