brexpiprazole Oral Tablet

Brand(s)
Rexulti
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Otsuka America Pharmaceutical, Inc. (2015-08-27)
Oldest Current Product
2015-07-10
License(s)
NDA
RxNORM
ORAL TABLET\BREXPIPRAZOLE
FDAOB
ORAL\TABLET\BREXPIPRAZOLE
SPL Active
ORAL\TABLET\BREXPIPRAZOLE
SPL Moiety
ORAL\TABLET\BREXPIPRAZOLE

product(s) by strength(s)

brexpiprazole 0.25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591480035RexultiNDAOtsuka America Pharmaceutical, Inc.2015-07-10BREXPIPRAZOLEORALTABLETNDA2054222d301358-6291-4ec1-bd87-37b4ad9bd850

brexpiprazole 0.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591480036RexultiNDAOtsuka America Pharmaceutical, Inc.2015-07-10BREXPIPRAZOLEORALTABLETNDA2054222d301358-6291-4ec1-bd87-37b4ad9bd850

brexpiprazole 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591480037RexultiNDAOtsuka America Pharmaceutical, Inc.2015-07-10BREXPIPRAZOLEORALTABLETNDA2054222d301358-6291-4ec1-bd87-37b4ad9bd850

brexpiprazole 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591480038RexultiNDAOtsuka America Pharmaceutical, Inc.2015-07-10BREXPIPRAZOLEORALTABLETNDA2054222d301358-6291-4ec1-bd87-37b4ad9bd850

brexpiprazole 3 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591480039RexultiNDAOtsuka America Pharmaceutical, Inc.2015-07-10BREXPIPRAZOLEORALTABLETNDA2054222d301358-6291-4ec1-bd87-37b4ad9bd850

brexpiprazole 4 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591480040RexultiNDAOtsuka America Pharmaceutical, Inc.2015-07-10BREXPIPRAZOLEORALTABLETNDA2054222d301358-6291-4ec1-bd87-37b4ad9bd850

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205422REXULTIOTSUKA PHARMACEUTICAL CO LTD2015-07-10p7888362
p8349840, ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD), SUBSTANCE
p8618109, TREATMENT OF SCHIZOPHRENIA
NEW CHEMICAL ENTITY [2020-07-10]NDA205422_001, NDA205422_002, NDA205422_003, NDA205422_004, NDA205422_005, NDA205422_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205422_001RXBREXPIPRAZOLE (0.25MG)ORALTABLETFalse2015-07-10REXULTI
2NDA205422_002RXBREXPIPRAZOLE (0.5MG)ORALTABLETFalse2015-07-10REXULTI
3NDA205422_003RXBREXPIPRAZOLE (1MG)ORALTABLETFalse2015-07-10REXULTI
4NDA205422_004RXBREXPIPRAZOLE (2MG)ORALTABLETFalse2015-07-10REXULTI
5NDA205422_005RXBREXPIPRAZOLE (3MG)ORALTABLETFalse2015-07-10REXULTI
6NDA205422_006RXBREXPIPRAZOLE (4MG)ORALTABLETTrue2015-07-10REXULTI

patent(s)

#idexpiration dateapplication(s)
1p7888362 (view patent)2027-02-23NDA205422
2p8349840 (view patent)2026-04-12NDA205422
3p8618109 (view patent)2026-04-12NDA205422

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
12d301358-6291-4ec1-bd87-37b4ad9bd850 (view SPL)These highlights do not include all the information needed to use REXULTI safely and effectively. See full prescribing information for REXULTI. REXULTI (brexpiprazole) tablets, for oral use Initial U.S. Approval: 2015prescriptionHuman PrescriptionOtsuka America Pharmaceutical, Inc.2015-08-272591480035, 591480036, 591480037, 591480038, 591480039, 591480040

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII