NDC 72060-142

CAPLYTA

Lumateperone

CAPLYTA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Intra-cellular Therapies, Inc. The primary component is Lumateperone.

Product ID72060-142_3916c6bb-0b58-4366-a339-d9610300304c
NDC72060-142
Product TypeHuman Prescription Drug
Proprietary NameCAPLYTA
Generic NameLumateperone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-02-01
Marketing CategoryNDA / NDA
Application NumberNDA209500
Labeler NameIntra-Cellular Therapies, Inc
Substance NameLUMATEPERONE
Active Ingredient Strength42 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 72060-142-30

3 BLISTER PACK in 1 CARTON (72060-142-30) > 10 CAPSULE in 1 BLISTER PACK (72060-142-01)
Marketing Start Date2020-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72060-142-01 [72060014201]

CAPLYTA CAPSULE
Marketing CategoryNDA
Application NumberNDA209500
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-01

NDC 72060-142-05 [72060014205]

CAPLYTA CAPSULE
Marketing CategoryNDA
Application NumberNDA209500
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-01

NDC 72060-142-30 [72060014230]

CAPLYTA CAPSULE
Marketing CategoryNDA
Application NumberNDA209500
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-01

NDC 72060-142-10 [72060014210]

CAPLYTA CAPSULE
Marketing CategoryNDA
Application NumberNDA209500
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-01

Drug Details

Active Ingredients

IngredientStrength
LUMATEPERONE42 mg/1

OpenFDA Data

SPL SET ID:db730b06-6351-47fd-8183-e61e61bbead5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2275613
  • 2275607
  • NDC Crossover Matching brand name "CAPLYTA" or generic name "Lumateperone"

    NDCBrand NameGeneric Name
    70518-3497CAPLYTAlumateperone
    72060-110CAPLYTAlumateperone
    72060-121CAPLYTAlumateperone
    72060-142CAPLYTAlumateperone

    Trademark Results [CAPLYTA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CAPLYTA
    CAPLYTA
    88742518 not registered Live/Pending
    INTRA-CELLULAR THERAPIES, INC.
    2019-12-30
    CAPLYTA
    CAPLYTA
    88742498 not registered Live/Pending
    INTRA-CELLULAR THERAPIES, INC.
    2019-12-30
    CAPLYTA
    CAPLYTA
    88340176 not registered Live/Pending
    INTRA-CELLULAR THERAPIES, INC.
    2019-03-14
    CAPLYTA
    CAPLYTA
    87334055 not registered Live/Pending
    INTRA-CELLULAR THERAPIES, INC.
    2017-02-13

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