FDA.reportPublic FDA data

Rexulti

Product NDC
59148-038
11-digit product format
591480038
Labeler code
59148
Product ID
59148-038_3a208135-0d99-4d6a-b73e-61d63cf48f4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brexpiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Otsuka America Pharmaceutical, Inc.
Application
NDA205422
Marketing category
NDA
Marketing start
2015-07-10
Substance
BREXPIPRAZOLE
Active strength
2 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rexulti
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BREXPIPRAZOLE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2J3YBM1K8C
Rxcui1658319, 1658325, 1658327, 1658329, 1658331, 1658333, 1658335, 1658337, 1658339, 1658341, 1658343, 1658345

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f98ce54-9f30-4e8a-8455-2d3e352e5314Product name220251106

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59148-038-132021-07-27C16284748780-1c7ccaba7-155a-fd44-e053-dadaa90aa01bThese 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: 2015
59148-038-132021-07-23C16284748780-1c7ccaba7-155a-fd44-e053-dadaa90aa01bThese 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: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59148-038-07Rexulti7 in 1 BLISTER PACKTABLET726
59148-038-07Rexulti1 in 1 CARTONTABLET126
59148-038-13Rexulti30 in 1 BOTTLETABLET3026
59148-038-13Rexulti1 in 1 CARTONTABLET126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-038-13EA - Each59148-038d27f1710-e671-4aa4-aff7-e5f20e526fd412015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
brexpiprazoleACTIVE INGREDIENT2J3YBM1K8CREXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
brexpiprazoleACTIVE MOIETY2J3YBM1K8CREXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UREXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTREXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
hydroxypropyl cellulose (type h)INACTIVE INGREDIENTRFW2ET671PREXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOREXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XREXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJREXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UREXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPREXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59148-038REXULTI (BREXPIPRAZOLE) TABLET REXULTI (BREXPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]24Current NDC, Legacy NDC, 4 package rows20250519_2d301358-6291-4ec1-bd87-37b4ad9bd850.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658319brexpiprazole 0.25 MG Oral TabletPSN2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658327brexpiprazole 0.5 MG Oral TabletPSN2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658331brexpiprazole 1 MG Oral TabletPSN2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658335brexpiprazole 2 MG Oral TabletPSN2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658339brexpiprazole 3 MG Oral TabletPSN2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658343brexpiprazole 4 MG Oral TabletPSN2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658325REXULTI 0.25 MG Oral TabletPSN2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658329REXULTI 0.5 MG Oral TabletPSN2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658333REXULTI 1 MG Oral TabletPSN2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658337REXULTI 2 MG Oral TabletPSN2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658341REXULTI 3 MG Oral TabletPSN2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658345REXULTI 4 MG Oral TabletPSN2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658325brexpiprazole 0.25 MG Oral Tablet [Rexulti]SBD2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658329brexpiprazole 0.5 MG Oral Tablet [Rexulti]SBD2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658333brexpiprazole 1 MG Oral Tablet [Rexulti]SBD2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658337brexpiprazole 2 MG Oral Tablet [Rexulti]SBD2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658341brexpiprazole 3 MG Oral Tablet [Rexulti]SBD2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658345brexpiprazole 4 MG Oral Tablet [Rexulti]SBD2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658319brexpiprazole 0.25 MG Oral TabletSCD2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658327brexpiprazole 0.5 MG Oral TabletSCD2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658331brexpiprazole 1 MG Oral TabletSCD2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658335brexpiprazole 2 MG Oral TabletSCD2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658339brexpiprazole 3 MG Oral TabletSCD2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658343brexpiprazole 4 MG Oral TabletSCD2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658325Rexulti 0.25 MG Oral TabletSY2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658329Rexulti 0.5 MG Oral TabletSY2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658333Rexulti 1 MG Oral TabletSY2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658337Rexulti 2 MG Oral TabletSY2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658341Rexulti 3 MG Oral TabletSY2d301358-6291-4ec1-bd87-37b4ad9bd85026
1658345Rexulti 4 MG Oral TabletSY2d301358-6291-4ec1-bd87-37b4ad9bd85026

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59148-038-07591480038071 BLISTER PACK in 1 CARTON (59148-038-07) / 7 TABLET in 1 BLISTER PACK1 blister pack2015-07-10YesNoCurrent
59148-038-13591480038131 BOTTLE in 1 CARTON (59148-038-13) / 30 TABLET in 1 BOTTLE1 bottle2015-07-100000-00-00NoNoCurrent