NDC 70518-3548

Rexulti

Brexpiprazole

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

Product ID70518-3548_ea235ac9-75e5-b1be-e053-2995a90a2e4e
NDC70518-3548
Product TypeHuman Prescription Drug
Proprietary NameRexulti
Generic NameBrexpiprazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-10-03
Marketing CategoryNDA /
Application NumberNDA205422
Labeler NameREMEDYREPACK INC.
Substance NameBREXPIPRAZOLE
Active Ingredient Strength2 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70518-3548-0

1 BOTTLE in 1 CARTON (70518-3548-0) > 30 TABLET in 1 BOTTLE
Marketing Start Date2022-10-03
NDC Exclude FlagN
Sample Package?N

Drug Details

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.