NDC 59148-037

Rexulti

Brexpiprazole

Rexulti is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Otsuka America Pharmaceutical, Inc.. The primary component is Brexpiprazole.

Product ID59148-037_31903d3f-5e72-4215-aeeb-71f10e424cf1
NDC59148-037
Product TypeHuman Prescription Drug
Proprietary NameRexulti
Generic NameBrexpiprazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-07-10
Marketing CategoryNDA / NDA
Application NumberNDA205422
Labeler NameOtsuka America Pharmaceutical, Inc.
Substance NameBREXPIPRAZOLE
Active Ingredient Strength1 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59148-037-13

1 BOTTLE in 1 CARTON (59148-037-13) > 30 TABLET in 1 BOTTLE
Marketing Start Date2015-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59148-037-13 [59148003713]

REXULTI TABLET
Marketing CategoryNDA
Application NumberNDA205422
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-10

Drug Details

Active Ingredients

IngredientStrength
BREXPIPRAZOLE1 mg/1

OpenFDA Data

SPL SET ID:2d301358-6291-4ec1-bd87-37b4ad9bd850
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1658343
  • 1658341
  • 1658345
  • 1658337
  • 1658325
  • 1658335
  • 1658327
  • 1658333
  • 1658331
  • 1658319
  • 1658329
  • 1658339
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    59148003713 REXULTI 1 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Rexulti" or generic name "Brexpiprazole"

    NDCBrand NameGeneric Name
    59148-035Rexultibrexpiprazole
    59148-036Rexultibrexpiprazole
    59148-037Rexultibrexpiprazole
    59148-038Rexultibrexpiprazole
    59148-039Rexultibrexpiprazole
    59148-040REXULTIREXULTI

    Trademark Results [Rexulti]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    REXULTI
    REXULTI
    79229625 5688217 Live/Registered
    Otsuka Pharmaceutical Co., Ltd.
    2017-12-14
    REXULTI
    REXULTI
    79114561 4287396 Live/Registered
    Otsuka Pharmaceutical Co., Ltd.
    2012-03-26

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