Home › NDC Lookup › Ingredients › Brexpiprazole › 59148-0038-13
Rexulti brexpiprazole 2 mg Tablet, 30-count — NDC 59148-0038-13 package photo

Rexulti brexpiprazole 2 mg Tablet, 30-count

by Otsuka America Pharmaceutical, Inc. · 1 BOTTLE in 1 CARTON (59148-038-13) / 30 TABLET in 1 BOTTLE
NDC 59148-0038-13
🏷️ FDA NDC (as labeled) 59148-038-13 billing pads the product segment with a zero
This package
Contains30-count Cost per ea$49.53 NADAC Per package$1,485.98 / 30 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $48.57/unit · Part D plans $51.03/unit — full pricing hub ↓
Also comes in: 7 tablets 59148-0038-07
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 59148-038-13
Product NDC 59148-038
11-digit billing NDC 59148003813
NCPDP billing unit EA — each (per item)
RxCUI 1658319, 1658325, 1658327, 1658329, 1658331, 1658333, 1658335, 1658337,
UNII 2J3YBM1K8C
UPC 0359148035130, 0359148040134, 0359148036137, 0359148038131 +2 more
Application # NDA205422
SPL Set ID 2d301358-6291-4ec1-bd87-37b4ad9bd850
Established class (EPC) Atypical Antipsychotic
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-07-10
Route ORAL
Dosage form TABLET
Substance BREXPIPRAZOLE
GPI-14 59250020000340
GPI class Rexulti
GCN Seq No 074446
GCN 38609
HICL code 042283
Ingredient (HICL) Brexpiprazole
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7X
Therapeutic class — specific (HIC3) Antipsychotics, Atyp, D2 Partial Agonist/5Ht Mixed
AHFS code 28:16.08.04
AHFS class Atypical Antipsychotics
FDB label name REXULTI 2 MG TABLET
FDB brand name Rexulti
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 59148-038-13 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59148-0038-13. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Atypical Antipsychotic class.

Pharmacologic class Atypical Antipsychotic
Drug family (ATC) Other antipsychotics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerOtsuka America Pharmaceutical, Inc.
Application holderOTSUKA PHARMACEUTICAL CO LTD
FDA applicationNDA205422 (NDA)
Labeler code59148
First marketedJul 2015
Product typeHuman Prescription Drug
Portfolio29 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name REXULTI 2 MG TABLET Ingredient Brexpiprazole
📖 What it is MedlinePlus · NLM

Brexpiprazole is used to treat: schizophrenia (a mental illness that affects how a person thinks, feels and behaves) depression, along with another antidepressant medication agitation in people with dementia due to Alzheimer's diseaseBrexpiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's not a traditional antidepressant on its own. Brexpiprazole is an atypical antipsychotic, but it's approved to be added on to an antidepressant when the antidepressant alone is...
  • What is brexpiprazole actually used for — and is it an antidepressant?
  • It typically takes 10 to 12 days of daily dosing for brexpiprazole to build up to stable levels in your body, and your prescriber will usually start you at a low dose and increase...
  • The most common ones people notice are weight gain, sleepiness, a restless urge to move (called akathisia), headache, and trouble sleeping. Most of these are manageable and worth d...
📖 Read our full Brexpiprazole guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Brown / Orange / Yellow / Green / Purple / White
ShapeRound
ImprintBRX;and;2
Size6 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 2165RE0K14
    A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $49.533 $1,485.98 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $48.57 $1,457.02 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $51.03 $1,530.97 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Jan 2024 May 2026 Aug 2026 $49.609 $39.888
▲ Up 24% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rexulti 2 mgthis 59148-0038-13 Otsuka 30 tablets $49.533 AB Availability likely —
Brexpiprazole 2 mg 27241-0207-30 Ajanta 30 tablets — — FDA listed —
Rexulti 2 mg 70518-3548-00 REMEDYREPACK 30 tablets — AB Discontinued —
Rexulti 2 mg 75929-0273-03 Pharma 30 tablets — AB Discontinued —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
First FDA approval
Jul 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 10, 2015 AB TE-rated RLD RS ⏳ ~6.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8618109 — method of use (U-543)
US 8349840 — method of use (U-1529)
US 8618109 — method of use (U-543)
US 9839637 — method of use (U-1529)
US 9839637 — method of use (U-543)
US 9839637 — method of use (U-1529)
US 9839637 — method of use (U-543)
US 9839637 — method of use (U-1529)
US 9839637 — method of use (U-543)
US 9839637 — method of use (U-543)
US 8349840 — method of use (U-1529)
US 8618109 — method of use (U-543)
US 8349840 — method of use (U-1529)
US 8618109 — method of use (U-543)
US 8618109 — method of use (U-543)
US 8349840 — method of use (U-1529)
US 9839637 — method of use (U-1529)
US 8618109 — method of use (U-543)
US 8349840 — method of use (U-1529)
US 9839637 — method of use (U-1529)
US 9839637 — method of use (U-543)
US 9839637 — method of use (U-1529)
US 9839637 — method of use (U-3281)
US 9839637 — method of use (U-3281)
US 9839637 — method of use (U-3281)
US 9839637 — method of use (U-3281)
US 9839637 — method of use (U-3281)
US 9839637 — method of use (U-3281)
US 8618109 — method of use (U-3281)
US 8618109 — method of use (U-3281)
US 8618109 — method of use (U-3281)
US 8618109 — method of use (U-3281)
US 8618109 — method of use (U-3281)
US 8618109 — method of use (U-3281)
US 9839637 — method of use (U-543)
US 8349840 — method of use (U-1529)
US 10307419 — drug product
US 10307419 — drug product
US 10307419 — drug product
US RE48059 — drug substance
US RE48059 — drug substance
US RE48059 — drug substance
US RE48059 — drug substance
US RE48059 — drug substance
US 10307419 — drug product
US RE48059 — drug substance
US 10307419 — drug product
US 9839637*PED — drug product
US 9839637*PED — drug product
US 9839637*PED — drug product
US 9839637*PED — drug product
US 9839637*PED — drug product
US 9839637*PED — drug product
US 8618109*PED — drug product
US 8618109*PED — drug product
US 8618109*PED — drug product
US 8618109*PED — drug product
US 8618109*PED — drug product
US 8618109*PED — drug product
US 8349840*PED — drug product
US 8349840*PED — drug product
US 8349840*PED — drug product
US 8349840*PED — drug product
US 8349840*PED — drug product
US 8349840*PED — drug product
US RE48059*PED — drug product
US RE48059*PED — drug product
US RE48059*PED — drug product
US RE48059*PED — drug product
US RE48059*PED — drug product
US RE48059*PED — drug product
US 10307419*PED — drug product
US 10307419*PED — drug product
US 10307419*PED — drug product
US 10307419*PED — drug product
US 10307419*PED — drug product
Exclusivity I-913
Exclusivity M-14
Exclusivity M-315
Exclusivity I-913
Exclusivity M-14
Exclusivity M-315
Exclusivity I-913
Exclusivity M-14
Exclusivity M-315
Exclusivity I-913
Exclusivity M-14
Exclusivity M-315
Exclusivity I-913
Exclusivity M-14
Exclusivity M-315
Exclusivity I-913
Exclusivity M-14
Exclusivity M-315
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
2015 2017 2019 2021 2023 2025 2027 2029 2031 2033
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (76)
PatentTypeUse codeExpires
US 8618109 ↗ Method of use U-543 Apr 12, 2026
US 8349840 ↗ Method of use U-1529 Apr 12, 2026
US 8618109 ↗ Method of use U-543 Apr 12, 2026
US 9839637 ↗ Method of use U-1529 Apr 12, 2026
US 9839637 ↗ Method of use U-543 Apr 12, 2026
US 9839637 ↗ Method of use U-1529 Apr 12, 2026
US 9839637 ↗ Method of use U-543 Apr 12, 2026
US 9839637 ↗ Method of use U-1529 Apr 12, 2026
US 9839637 ↗ Method of use U-543 Apr 12, 2026
US 9839637 ↗ Method of use U-543 Apr 12, 2026
US 8349840 ↗ Method of use U-1529 Apr 12, 2026
US 8618109 ↗ Method of use U-543 Apr 12, 2026
US 8349840 ↗ Method of use U-1529 Apr 12, 2026
US 8618109 ↗ Method of use U-543 Apr 12, 2026
US 8618109 ↗ Method of use U-543 Apr 12, 2026
US 8349840 ↗ Method of use U-1529 Apr 12, 2026
US 9839637 ↗ Method of use U-1529 Apr 12, 2026
US 8618109 ↗ Method of use U-543 Apr 12, 2026
US 8349840 ↗ Method of use U-1529 Apr 12, 2026
US 9839637 ↗ Method of use U-1529 Apr 12, 2026
US 9839637 ↗ Method of use U-543 Apr 12, 2026
US 9839637 ↗ Method of use U-1529 Apr 12, 2026
US 9839637 ↗ Method of use U-3281 Apr 12, 2026
US 9839637 ↗ Method of use U-3281 Apr 12, 2026
US 9839637 ↗ Method of use U-3281 Apr 12, 2026
US 9839637 ↗ Method of use U-3281 Apr 12, 2026
US 9839637 ↗ Method of use U-3281 Apr 12, 2026
US 9839637 ↗ Method of use U-3281 Apr 12, 2026
US 8618109 ↗ Method of use U-3281 Apr 12, 2026
US 8618109 ↗ Method of use U-3281 Apr 12, 2026
US 8618109 ↗ Method of use U-3281 Apr 12, 2026
US 8618109 ↗ Method of use U-3281 Apr 12, 2026
US 8618109 ↗ Method of use U-3281 Apr 12, 2026
US 8618109 ↗ Method of use U-3281 Apr 12, 2026
US 9839637 ↗ Method of use U-543 Apr 12, 2026
US 8349840 ↗ Method of use U-1529 Apr 12, 2026
US 10307419 ↗ Drug product — Oct 12, 2032
US 10307419 ↗ Drug product — Oct 12, 2032
US 10307419 ↗ Drug product — Oct 12, 2032
US RE48059 ↗ Drug substance — Dec 23, 2028
US RE48059 ↗ Drug substance — Dec 23, 2028
US RE48059 ↗ Drug substance — Dec 23, 2028
US RE48059 ↗ Drug substance — Dec 23, 2028
US RE48059 ↗ Drug substance — Dec 23, 2028
US 10307419 ↗ Drug product — Oct 12, 2032
US RE48059 ↗ Drug substance — Dec 23, 2028
US 10307419 ↗ Drug product — Oct 12, 2032
US 9839637*PED ↗ Drug product — Oct 12, 2026
US 9839637*PED ↗ Drug product — Oct 12, 2026
US 9839637*PED ↗ Drug product — Oct 12, 2026
US 9839637*PED ↗ Drug product — Oct 12, 2026
US 9839637*PED ↗ Drug product — Oct 12, 2026
US 9839637*PED ↗ Drug product — Oct 12, 2026
US 8618109*PED ↗ Drug product — Oct 12, 2026
US 8618109*PED ↗ Drug product — Oct 12, 2026
US 8618109*PED ↗ Drug product — Oct 12, 2026
US 8618109*PED ↗ Drug product — Oct 12, 2026
US 8618109*PED ↗ Drug product — Oct 12, 2026
US 8618109*PED ↗ Drug product — Oct 12, 2026
US 8349840*PED ↗ Drug product — Oct 12, 2026
US 8349840*PED ↗ Drug product — Oct 12, 2026
US 8349840*PED ↗ Drug product — Oct 12, 2026
US 8349840*PED ↗ Drug product — Oct 12, 2026
US 8349840*PED ↗ Drug product — Oct 12, 2026
US 8349840*PED ↗ Drug product — Oct 12, 2026
US RE48059*PED ↗ Drug product — Jun 23, 2029
US RE48059*PED ↗ Drug product — Jun 23, 2029
US RE48059*PED ↗ Drug product — Jun 23, 2029
US RE48059*PED ↗ Drug product — Jun 23, 2029
US RE48059*PED ↗ Drug product — Jun 23, 2029
US RE48059*PED ↗ Drug product — Jun 23, 2029
US 10307419*PED ↗ Drug product — Apr 12, 2033
US 10307419*PED ↗ Drug product — Apr 12, 2033
US 10307419*PED ↗ Drug product — Apr 12, 2033
US 10307419*PED ↗ Drug product — Apr 12, 2033
US 10307419*PED ↗ Drug product — Apr 12, 2033
FDA exclusivity
CodeWhat it grantsExpires
I-913New indication (3-year)May 10, 2026
M-14New indication / labeling change (3-year)May 8, 2027
M-315New indication / labeling change (3-year)May 9, 2028
I-913New indication (3-year)May 10, 2026
M-14New indication / labeling change (3-year)May 8, 2027
M-315New indication / labeling change (3-year)May 9, 2028
I-913New indication (3-year)May 10, 2026
M-14New indication / labeling change (3-year)May 8, 2027
M-315New indication / labeling change (3-year)May 9, 2028
I-913New indication (3-year)May 10, 2026
M-14New indication / labeling change (3-year)May 8, 2027
M-315New indication / labeling change (3-year)May 9, 2028
I-913New indication (3-year)May 10, 2026
M-14New indication / labeling change (3-year)May 8, 2027
M-315New indication / labeling change (3-year)May 9, 2028
I-913New indication (3-year)May 10, 2026
M-14New indication / labeling change (3-year)May 8, 2027
M-315New indication / labeling change (3-year)May 9, 2028
PEDPediatric Exclusivity (+6 months)Nov 8, 2027
PEDPediatric Exclusivity (+6 months)Nov 8, 2027
PEDPediatric Exclusivity (+6 months)Nov 8, 2027
PEDPediatric Exclusivity (+6 months)Nov 8, 2027
PEDPediatric Exclusivity (+6 months)Nov 8, 2027
PEDPediatric Exclusivity (+6 months)Nov 8, 2027
PEDPediatric Exclusivity (+6 months)Nov 10, 2026
PEDPediatric Exclusivity (+6 months)Nov 10, 2026
PEDPediatric Exclusivity (+6 months)Nov 10, 2026
PEDPediatric Exclusivity (+6 months)Nov 10, 2026
PEDPediatric Exclusivity (+6 months)Nov 10, 2026
PEDPediatric Exclusivity (+6 months)Nov 10, 2026
Common questions
Is there a generic version of REXULTI 2 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for REXULTI 2 MG TABLET. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 59148-0038-13, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
98.5K
Units reimbursed last 4 qtrs
3.1M
Gross reimbursed last 4 qtrs
$148.5M
Avg / prescription
$1,506.94
Avg / unit
$48.5673
Latest quarter Q4 2025
24.4KRx
Medicaid pays / ea
$48.5673
gross reimbursed
vs
NADAC / ea
$49.5327
acquisition cost
=
Spread
−$0.9654
-2% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
48% FFS 52% MCO
Fee-for-service · 47,409 Rx Managed care · 51,133 Rx
State Medicaid map
Alaska: 5,099 units · 696 per 100k residents AK Maine: 11,960 units · 857 per 100k residents ME Washington: 36,532 units · 468 per 100k residents WA Idaho: 16,071 units · 818 per 100k residents ID Montana: 3,041 units · 269 per 100k residents MT North Dakota: 2,481 units · 317 per 100k residents ND Minnesota: 32,844 units · 572 per 100k residents MN Wisconsin: 55,628 units · 941 per 100k residents WI Michigan: 286,946 units · 2,859 per 100k residents MI New York: 179,306 units · 916 per 100k residents NY Vermont: 1,140 units · 176 per 100k residents VT New Hampshire: 7,523 units · 537 per 100k residents NH Oregon: 68,139 units · 1,610 per 100k residents OR Nevada: 47,199 units · 1,478 per 100k residents NV Wyoming: 2,218 units · 380 per 100k residents WY South Dakota: 8,283 units · 901 per 100k residents SD Iowa: 67,722 units · 2,112 per 100k residents IA Illinois: 55,600 units · 443 per 100k residents IL Indiana: 192,700 units · 2,808 per 100k residents IN Ohio: 271,777 units · 2,306 per 100k residents OH Pennsylvania: 90,215 units · 696 per 100k residents PA New Jersey: 32,616 units · 351 per 100k residents NJ Massachusetts: 62,687 units · 895 per 100k residents MA California: 286,235 units · 735 per 100k residents CA Utah: 21,123 units · 618 per 100k residents UT Colorado: 59,092 units · 1,005 per 100k residents CO Nebraska: 26,616 units · 1,346 per 100k residents NE Missouri: 119,148 units · 1,923 per 100k residents MO Kentucky: 126,707 units · 2,800 per 100k residents KY West Virginia: 11,104 units · 627 per 100k residents WV Virginia: 72,136 units · 828 per 100k residents VA Maryland: 24,154 units · 391 per 100k residents MD Connecticut: 68,338 units · 1,889 per 100k residents CT Rhode Island: 9,229 units · 843 per 100k residents RI Arizona: 11,715 units · 158 per 100k residents AZ New Mexico: 24,437 units · 1,156 per 100k residents NM Kansas: 29,153 units · 992 per 100k residents KS Arkansas: 18,884 units · 616 per 100k residents AR Tennessee: 60,487 units · 849 per 100k residents TN North Carolina: 149,381 units · 1,379 per 100k residents NC South Carolina: 15,243 units · 284 per 100k residents SC Delaware: 16,999 units · 1,649 per 100k residents DE Oklahoma: 32,679 units · 806 per 100k residents OK Louisiana: 93,027 units · 2,034 per 100k residents LA Mississippi: 6,774 units · 230 per 100k residents MS Alabama: 45,611 units · 893 per 100k residents AL Georgia: 22,107 units · 200 per 100k residents GA D.C.: no data reported DC Hawaii: 7,671 units · 535 per 100k residents HI Texas: 88,024 units · 289 per 100k residents TX Florida: 73,739 units · 326 per 100k residents FL
Units reimbursed · per 100k residents
1582,859
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Michigan 2,859 /100k
2 Indiana 2,808 /100k
3 Kentucky 2,800 /100k
4 Ohio 2,306 /100k
5 Iowa 2,112 /100k
6 Louisiana 2,034 /100k
7 Missouri 1,923 /100k
8 Connecticut 1,889 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 tablets this page59148-0038-13 98,542 Rx · $148,496,562
7 tablets59148-0038-07 No Medicaid data
Drug total (last 4 qtrs): 98,542 Rx · 3,057,540 units · $148,496,562 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Rexulti — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Rexulti. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$301.02M
Claims incl. refills
221K
Beneficiaries
79.3K
Spend / beneficiary
$3,795.15
Spend / claim
$1,361.94
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
59148-0038-13 You're viewing this 1 BOTTLE in 1 CARTON (59148-038-13) / 30 TABLET in 1 BOTTLE $49.53 / ea $1,485.98 2015-07-10 Active
59148-0038-07 1 BLISTER PACK in 1 CARTON (59148-038-07) / 7 TABLET in 1 BLISTER PACK — — 2015-07-10 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 59148-0038-13?
NDC 59148-0038-13 is a 30-count package — 1 bottle in 1 carton / 30 tablet in 1 bottle.
What is the difference between NDC 59148-0038-13 and NDC 59148-0038-07?
Both are Rexulti brexpiprazole 2 mg Tablet — the drug itself is identical. NDC 59148-0038-13 is the 30-count package, while NDC 59148-0038-07 is the 7 tablets package.
What NDC number is used to bill for this package of Rexulti brexpiprazole 2 mg Tablet?
Bill NDC 59148-0038-13 — the 11-digit billing format is 59148003813. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer's disease.

( 5.1 ) Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Safety and effectiveness of REXULTI have not been established in pediatric patients with MDD.

( 5.2 , 8.4 ) Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer's disease [see Warnings and Precautions (5.1) ] . Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients and young adult patients in short-term studies.

Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.2) ] . The safety and effectiveness of REXULTI have not been established in pediatric patients with MDD [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] .

🎯 Indications and Usage 158 words ▾

1 INDICATIONS AND USAGE REXULTI is indicated for: Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with dementia due to Alzheimer's disease Limitations of Use: REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease [see Clinical Studies (14.3) ] . REXULTI is an atypical antipsychotic indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 , 14.1 ) Treatment of schizophrenia in adults and pediatric patients ages 13 years and older ( 1 , 14.2 ) Treatment of agitation associated with dementia due to Alzheimer's disease ( 1 , 14.3 ) Limitations of Use : REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer REXULTI orally once daily with or without food. ( 2 , 12.3 ) Indication Starting Dosage Recommended Target Dosage Maximum Dosage MDD Adults ( 2.2 ) 0.5 mg/day or 1 mg/day 2 mg/day 3 mg/day Schizophrenia Adults ( 2.3 ) 1 mg/day 2 to 4 mg/day 4 mg/day Schizophrenia Pediatric (13 - 17 years) ( 2.3 ) 0.5 mg/day 2 to 4 mg/day 4 mg/day Agitation associated with dementia due to Alzheimer's disease ( 2.4 ) 0.5 mg/day 2 mg/day 3 mg/day Moderate to Severe Hepatic Impairment: Maximum recommended dosage is 2 mg once daily for patients with MDD or agitation associated with dementia due to Alzheimer's disease and 3 mg once daily for patients with schizophrenia.

( 2.5 ) CrCl<60 mL/minute: Maximum recommended dosage is 2 mg once daily for patients with MDD or agitation associated with dementia due to Alzheimer's disease and 3 mg once daily for patients with schizophrenia. ( 2.6 ) See Full Prescribing Information for dosage modifications for CYP2D6 poor metabolizers and for concomitant use with CYP inhibitors or inducers. ( 2.7 )

2.1Administration Information Administer REXULTI orally, once daily with or without food [see Clinical Pharmacology (12.3) ].

2.2Recommended Dosage for Adjunctive Treatment of Major Depressive Disorder (Adults) The recommended starting REXULTI dosage for the adjunctive treatment of MDD in adults is 0.5 mg or 1 mg orally once daily . Titrate to 1 mg once daily, then titrate to the target dosage of 2 mg once daily (based on the patient's clinical response and tolerability, increase the dosage at weekly intervals). The maximum recommended daily dosage is 3 mg.

Periodically reassess to determine the continued need and appropriate dosage for treatment.

2.3Recommended Dosage for Schizophrenia (Adults and Pediatric Patients 13 to 17 Years) Adults The recommended starting REXULTI dosage for the treatment of schizophrenia in adults is 1 mg orally once daily on Days 1 to 4. Titrate to 2 mg once daily on Day 5 through Day 7. On Day 8, the dosage can be increased to the maximum recommended daily dosage of 4 mg based on clinical response and tolerability.

The recommended target dosage is 2 mg to 4 mg once daily. Pediatric Patients (13 to 17 years of age) The recommended starting REXULTI dosage for the treatment of schizophrenia in pediatric patients 13 to 17 years of age is 0.5 mg orally once daily on Days 1 to 4. On Days 5 through 7, titrate to 1 mg per day and on Day 8 titrate to 2 mg based on clinical response and tolerability.

Weekly dose increases can be made in 1 mg increments. A recommended target dosage is 2 to 4 mg once daily. The maximum recommended daily dosage is 4 mg.

2.4Recommended Dosage for Agitation Associated with Dementia Due to Alzheimer's Disease The recommended starting REXULTI dosage for the treatment of agitation associated with dementia due to Alzheimer's disease is 0.5 mg orally once daily on Days 1 to 7 . Increase the dosage on Days 8 through 14 to 1 mg once daily, and on Day 15 to 2 mg once daily. The recommended target dose is 2 mg once daily.

The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, based on clinical response and tolerability.

2.5Recommended Dosage in Patients with Hepatic Impairment The maximum recommended dosage in patients with moderate to severe hepatic impairment (Child-Pugh score ≥7) is [see Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ]: 2 mg orally once daily in patients with MDD or agitation associated with dementia due to Alzheimer's disease, and 3 mg orally once daily in patients with schizophrenia

2.6Recommended Dosage in Patients with Renal Impairment The maximum recommended dosage in patients with creatinine clearance CrCl<60 mL/minute is [see Use in Specific Populations (8.8) , Clinical Pharmacology (12.3) ]: 2 mg orally once daily in patients with MDD or agitation associated with dementia due to Alzheimer's disease and 3 mg orally once daily in patients…

💊 Dosage Forms and Strengths 142 words ▾

3 DOSAGE FORMS AND STRENGTHS REXULTI tablets are available in 6 strengths: 0.25 mg tablets are light brown, round, shallow convex, bevel-edged body with "BRX" and "0.25" imprinted on one side. 0.5 mg tablets: are light orange, round, shallow convex, bevel-edged body with "BRX" and "0.5" imprinted on one side. 1 mg tablets are light yellow, round, shallow convex, bevel-edged body with "BRX" and "1" imprinted on one side.

2 mg tablets are light green, round, shallow convex, bevel-edged body with "BRX" and "2" imprinted on one side. 3 mg tablets are light purple, round, shallow convex, bevel-edged body with "BRX" and "3" imprinted on one side. 4 mg tablets are white, round, shallow convex, bevel-edged body with "BRX" and "4" imprinted on one side.

Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg ( 3 )

⛔ Contraindications 39 words ▾

4 CONTRAINDICATIONS REXULTI is contraindicated in patients with a known hypersensitivity to brexpiprazole or any of its components. Reactions have included rash, facial swelling, urticaria, and anaphylaxis. Known hypersensitivity to REXULTI or any of its components ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) ( 5.3 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. ( 5.4 ) Tardive Dyskinesia: Discontinue if clinically appropriate. ( 5.5 ) Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.

( 5.6 ) Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation. ( 5.7 ) Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing REXULTI if a clinically significant decline in WBC occurs in absence of other causative factors.

( 5.8 ) Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope. ( 5.9 ) Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. ( 5.11 ) Potential for Cognitive and Motor Impairment: Use caution when operating machinery.

( 5.14 )

5.1Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in the drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.

Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer's disease [see Boxed Warning , Warnings and Precautions (5.3) ] .

5.2Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in patients 24 years of age and younger was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 2 .

No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. Table 2 Risk Differences of the Number of Patients with Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric REXULTI is not approved in pediatric patients with MDD. and Adult Patients Age Range (years) Drug-Placebo Difference in Number of Patients with Suicidal Thoughts or Behaviors per 1,000 Patients Treated Increases Compared to Placebo <18 14 additional patients 18 to 24 5 additional patients Decreases Compared to Placebo 25 to 64 1 fewer patient ≥65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months.

However, there is substantial evidence from placebo-controlled maintenance studies in adults with MDD that antidepressants delay the recurrence of depression. Monitor all antidepressant-treated pat…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning , Warnings and Precautions (5.1) ] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Boxed Warning , Warnings and Precautions (5.2) ] Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions (5.7) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.8) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.9) ] Falls [see Warnings and Precautions (5.10) ] Seizures [see Warnings and Precautions (5.11) ] Body Temperature Dysregulation [see Warnings and Precautions (5.12) ] Dysphagia [see Warnings and Precautions (5.13) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.14) ] Most common adverse reactions in adults were ( 6.1 ): Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy): Weight increased, somnolence, and akathisia (≥5% and at least twice the rate for placebo) Adult Patients with schizophrenia : Weight increased (≥4% and at least twice the rate for placebo) Pediatric patients (13 to 17 years) with schizophrenia : Extrapyramidal symptoms, excluding akathisia (≥5% and at least twice the rate for placebo) Adult patients with agitation associated with dementia due to Alzheimer's disease: Nasopharyngitis, dizziness (≥4% and at least twice the rate for placebo) To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most common adverse reactions in adult patients in clinical trials (≥5%) were weight increased, akathisia, headache, somnolence, and insomnia. The most common adverse reactions in pediatric patients in clinical trials (≥5%) were weight increased, somnolence, headache, akathisia, and nasopharyngitis.

Brexpiprazole has been evaluated for safety in 12,550 adult patients who participated in multiple-dose clinical trials for major depressive disorder, schizophrenia, agitation associated with dementia due to Alzheimer's disease, attention deficit hyperactivity disorder (ADHD), post-traumatic stress disorder (PTSD), bipolar mania, and borderline personality disorder (BPD). Among them, 3,870 patients were treated with brexpiprazole for at least 180 days, and 1,910 patients were treated for at least one year of exposure.

Additionally, brexpiprazole has been evaluated for safety in 119 pediatric patients who participated in short-term trials, and 314 patients in long-term multiple-dose clinical trials for pediatric schizophrenia and autism spectrum disorders (ASD). Adjunctive Treatment in Major Depressive Disorder (MDD) The safety of REXULTI was evaluated in 1054 adult patients (18 to 65 years of age) diagnosed with MDD who participated in two 6-week placebo-controlled, fixed-dose clinical studies in patients with major depressive disorder in which REXULTI was administered at doses of 1 mg to 3 mg daily as adjunctive treatment to continued antidepressant therapy; patients in the placebo group continued to receive antidepressant therapy [see Clinical Studies (14.1) ] .

Adverse Reactions Reported as Reasons for Discontinuation of Treatment A total o…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Factors Dosage Adjustments for REXULTI ( 2.7 ) Strong CYP2D6 REXULTI may be administered without dosage adjustment in patients with MDD when administered with strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine). or CYP3A4 inhibitors Administer half of recommended dosage. Strong/moderate CYP2D6 with Strong/moderate CYP3A4 inhibitors Administer a quarter of the recommended dosage. Known CYP2D6 poor metabolizers taking strong/moderate CYP3A4 inhibitors Administer a quarter of the recommended dosage.

Strong CYP3A4 inducers Double the recommended dosage and further adjust based on clinical response.

7.1Drugs Having Clinically Important Interactions with REXULTI See Table 12 for clinically important drug interactions with REXULTI. Table 12 Clinically Important Drug Interactions with REXULTI Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of REXULTI with strong CYP3A4 inhibitors increased the exposure of brexpiprazole compared to the use of REXULTI alone [see Clinical Pharmacology (12.3) ] . Intervention: With concomitant use of REXULTI with a strong CYP3A4 inhibitor, reduce the REXULTI dosage [see Dosage and Administration (2.7) ] .

Strong CYP2D6 Inhibitors In the clinical studies examining the adjunctive use of REXULTI in the treatment of MDD, dosage was not adjusted for strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine). Thus, CYP considerations are already factored into general dosing recommendations, and REXULTI may be administered without dosage adjustment in patients with MDD. Clinical Impact: Concomitant use of REXULTI with strong CYP2D6 inhibitors increased the exposure of brexpiprazole compared to the use of REXULTI alone [see Clinical Pharmacology (12.3) ] .

Intervention: With concomitant use of REXULTI with a strong CYP2D6 inhibitor, reduce the REXULTI dosage [see Dosage and Administration (2.7) ] . Both CYP3A4 Inhibitors and CYP2D6 Inhibitors Clinical Impact: Concomitant use of REXULTI with 1) a strong CYP3A4 inhibitor and a strong CYP2D6 inhibitor; or 2) a moderate CYP3A4 inhibitor and a strong CYP2D6 inhibitor; or 3) a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor; or 4) a moderate CYP3A4 inhibitor and a moderate CYP2D6 inhibitor increased the exposure of brexpiprazole compared to the use of REXULTI alone [see Clinical Pharmacology (12.3) ].

Intervention: With concomitant use of REXULTI with 1) a strong CYP3A4 inhibitor and a strong CYP2D6 inhibitor; or 2) a moderate CYP3A4 inhibitor and a strong CYP2D6 inhibitor; or 3) a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor; or 4) a moderate CYP3A4 inhibitor and a moderate CYP2D6 inhibitor, decrease the REXULTI dosage [see Dosage and Administration (2.7) ]. Strong CYP3A4 Inducers Clinical Impact: Concomitant use of REXULTI and a strong CYP3A4 inducer decreased the exposure of brexpiprazole compared to the use of REXULTI alone [see Clinical Pharmacology (12.3) ].

Intervention: With concomitant use of REXULTI with a strong CYP3A4 inducer, increase the REXULTI dosage [see Dosage and Administration (2.7) ].

7.2Drugs Having No Clinically Important Interactions with REXULTI Based on pharmacokinetic studies, no dosage adjustment of REXULTI is required when administered concomitantly with CYP2B6 inhibitors (e.g., ticlopidine) or gastric pH modifiers (e.g., omeprazole). Additionally, no dosage adjustment for substrates of CYP2D6 (e.g., dextromethorphan), CYP3A4 (e.g., lovastatin), CYP2B6 (e.g., bupropion), BCRP (e.g., rosuvastatin), or P-gp (e.g., fexofenadine) is required when administered concomitantly with REXULTI.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure ( 8.1 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REXULTI during pregnancy. For more information contact the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . Risk Summary Adequate and well-controlled studies have not been conducted with REXULTI in pregnant women to inform drug-associated risks.

However, neonates whose mothers are exposed to antipsychotic drugs, like REXULTI, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. In animal reproduction studies, no teratogenicity was observed with oral administration of brexpiprazole to pregnant rats and rabbits during organogenesis at doses up to 73 and 146 times, respectively, of maximum recommended human dose (MRHD) of 4 mg/day on a mg/m 2 basis. However, when pregnant rats were administered brexpiprazole during the period of organogenesis through lactation, the number of perinatal deaths of pups was increased at 73 times the MRHD [see Data ] .

The background risk of major birth defects and miscarriage for the indicated population(s) is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder, have been reported in neonates whose mothers were exposed to antipsychotic drugs during the third trimester of pregnancy.

These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately.

Data Animal Data Pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day (7.3, 24, and 73 times the MRHD on a mg/m 2 basis) of brexpiprazole during the period of organogenesis. Brexpiprazole was not teratogenic and did not cause adverse developmental effects at doses up to 73 times the MRHD. Pregnant rabbits were treated with oral doses of 10, 30, and 150 mg/kg/day (49, 146, and 730 times the MRHD) of brexpiprazole during the period of organogenesis.

Brexpiprazole was not teratogenic and did not cause adverse developmental effects at doses up to 146 times the MRHD. Findings of decreased body weight, retarded ossification, and increased incidences of visceral and skeletal variations were observed in fetuses at 730 times the MRHD, a dose that induced maternal toxicity. In a study in which pregnant rats were administered oral doses of 3, 10, and 30 mg/kg/day (7.3, 24, and 73 times the MRHD) during the period of organogenesis and through lactation, the number of live-born pups was decreased, and early postnatal deaths increased at a dose 73 times the MRHD.

Impaired nursing by dams, and low birth weight and decreased body weight gain in pups were observed at 73 times, but not at 24 times, the MRHD.

8.2Lactation Risk Summary Lactation studies have not been conducted to assess the presence of brexpiprazole in human milk, the effects of brexpiprazole on the breastfed infant, or the effects of brexpiprazole on milk production. Brexpiprazole is present in rat milk. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for REXULTI and any potential adverse effects on the breastfed infant from REXULTI or from the underlying maternal condition.

8.4Pediatric Use Schizophrenia The safety and effectiveness of REXULTI for treatment of schizophrenia have…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REXULTI during pregnancy. For more information contact the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . Risk Summary Adequate and well-controlled studies have not been conducted with REXULTI in pregnant women to inform drug-associated risks.

However, neonates whose mothers are exposed to antipsychotic drugs, like REXULTI, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. In animal reproduction studies, no teratogenicity was observed with oral administration of brexpiprazole to pregnant rats and rabbits during organogenesis at doses up to 73 and 146 times, respectively, of maximum recommended human dose (MRHD) of 4 mg/day on a mg/m 2 basis. However, when pregnant rats were administered brexpiprazole during the period of organogenesis through lactation, the number of perinatal deaths of pups was increased at 73 times the MRHD [see Data ] .

The background risk of major birth defects and miscarriage for the indicated population(s) is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder, have been reported in neonates whose mothers were exposed to antipsychotic drugs during the third trimester of pregnancy.

These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately.

Data Animal Data Pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day (7.3, 24, and 73 times the MRHD on a mg/m 2 basis) of brexpiprazole during the period of organogenesis. Brexpiprazole was not teratogenic and did not cause adverse developmental effects at doses up to 73 times the MRHD. Pregnant rabbits were treated with oral doses of 10, 30, and 150 mg/kg/day (49, 146, and 730 times the MRHD) of brexpiprazole during the period of organogenesis.

Brexpiprazole was not teratogenic and did not cause adverse developmental effects at doses up to 146 times the MRHD. Findings of decreased body weight, retarded ossification, and increased incidences of visceral and skeletal variations were observed in fetuses at 730 times the MRHD, a dose that induced maternal toxicity. In a study in which pregnant rats were administered oral doses of 3, 10, and 30 mg/kg/day (7.3, 24, and 73 times the MRHD) during the period of organogenesis and through lactation, the number of live-born pups was decreased, and early postnatal deaths increased at a dose 73 times the MRHD.

Impaired nursing by dams, and low birth weight and decreased body weight gain in pups were observed at 73 times, but not at 24 times, the MRHD.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Schizophrenia The safety and effectiveness of REXULTI for treatment of schizophrenia have been established in pediatric patients 13 years of age and older. Use of REXULTI in this population is supported by evidence from adequate and well-controlled studies in adults and pediatric patients with schizophrenia, pharmacokinetic data from adults and pediatric patients, and safety data in pediatric patients 13 to 17 years of age [see Warnings and Precautions (5.6) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical Studies (14.2) ] .

The safety and effectiveness of REXULTI for the treatment of schizophrenia have not been established in pediatric patients less than 13 years of age. Major Depressive Disorder The safety and effectiveness of REXULTI for treatment of major depressive disorder have not been established in pediatric patients. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning , Warnings and Precautions (5.2) ] .

Irritability Associated with Autism Spectrum Disorder The safety and effectiveness of REXULTI for the treatment of irritability associated with autism spectrum disorder have not been established in pediatric patients. Effectiveness was not demonstrated, in an 8-week, double-blind, placebo-controlled, flexible-dose clinical study conducted in 119 REXULTI-treated pediatric patients 5 to 17 years of age with irritability associated with autism spectrum disorder diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, 5 th Edition [DSM-5] criteria.

In this study, somnolence (including sedation) occurred at a higher rate than reported in other REXULTI studies evaluating adults and elderly patients (16% in REXULTI-treated pediatric patients versus 5% for placebo). The mean increase in age-and-gender adjusted body weight z-score from baseline to last visit was 0.3 for REXULTI-treated patients versus 0.1 for placebo-treated patients. Increases in age-and-gender adjusted body weight z-score of at least

0.5SD from baseline was higher in REXULTI-treated patients versus placebo (19% versus 5%). Of the 119 patients from this study, 95 patients entered the open-label treatment study and received up to 26 weeks of daily treatment with brexpiprazole. During the open-label treatment period, 2% of patients discontinued due to weight increase.

In patients previously treated with REXULTI for 8 weeks, the mean increase in weight from the open-label study baseline to last visit was 4.5 kg and 26% of patients had an increase in age-and-gender-adjusted body weight z-score of at least

0.5SD from baseline. Juvenile Animal Studies Juvenile rats were administered oral doses of brexpiprazole of 3, 10, and 20 mg/kg/day once daily beginning from weaning (postnatal day 21) through adulthood (postnatal day 90), followed by a 4-week recovery (non-dosing) period. Results were similar to those observed in previous repeat‑dose toxicity studies in adolescent (8-week-old) rats.

Mortality occurred at the high dose of 20 mg/kg/day, as well as delayed sexual maturation in males and decreased rearing and motor activity. There was no evidence of neurotoxicity or effects on fertility and reproductive function. Histopathologic changes in reproductive organs and mammary glands occurred at all doses, were related to the pharmacology of brexpiprazole and were comparable to those in adult rats.

All findings were at least partially reversible. Juvenile dogs were administered oral doses of brexpiprazole of 1, 3, and 30 mg/kg/day once daily starting at 8 or 9 weeks of age for 26 weeks, followed by an 8-week recovery (non-dosing) period. Decreases in body weight, lethargy, changes in heart rate, and immature male sex organs were observed at 30 mg/kg/day.

These findings were at least partially reversible.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Antipsychotic drugs increase the risk of death in elderly patients with dementia-related psychosis. REXULTI is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning , Warnings and Precautions (5.1) ] . Adjunctive Treatment of Major Depressive Disorder (MDD) and Schizophrenia Of the total number of REXULTI-treated patients in the clinical studies for the adjunctive therapy to antidepressants for MDD and for schizophrenia, 248 (3%) were 65 years of age and older (which included 45 (18%) patients who were 75 years of age and older).

Clinical studies of REXULTI in these patients did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. In general, dosage selection for the treatment of MDD or schizophrenia in a geriatric patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, and cardiac function, concomitant diseases, and other drug therapy. Agitation Associated with Dementia Due to Alzheimer's Disease The total number of REXULTI-treated patients 65 years of age and older in the clinical studies for agitation associated with dementia due to Alzheimer's disease (Studies 6 and 7) was 448 (86%) including 170 (33%) patients 65 to 74 years of age, 228 (44%) patients 75 to 84 years of age, and 50 (10%) patients 85 years of age and older [see Clinical Studies (14.3) ] .

In clinical studies of REXULTI for the treatment of agitation associated with dementia due to Alzheimer's disease did not include sufficient numbers of younger adult patients to determine if patients 65 years of age and older respond differently than younger adult patients.

🆘 Overdosage 144 words ▾

10 OVERDOSAGE There is limited clinical trial experience regarding human overdosage with REXULTI. Management of a REXULTI overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms. Close medical supervision and monitoring should continue until the patient recovers.

Consider contacting the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Oral activated charcoal and sorbitol (50 g/240 mL), administered one hour after ingesting oral REXULTI, decreased brexpiprazole C max and area under the curve (AUC) by approximately 5% to 23% and 31% to 39% respectively; however, there is insufficient information available on the therapeutic potential of activated charcoal in treating an overdose with REXULTI. There is no information on the effect of hemodialysis in treating an overdose with REXULTI; hemodialysis is unlikely to be useful because brexpiprazole is highly bound to plasma proteins.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of REXULTI in the adjunctive treatment of major depressive disorder, treatment of agitation associated with dementia due to Alzheimer's disease, or treatment of schizophrenia is unknown. However, the efficacy of REXULTI may be mediated through a combination of partial agonist activity at serotonin 5-HT 1A and dopamine D 2 receptors, and antagonist activity at serotonin 5-HT 2A receptors.

12.2Pharmacodynamics Brexpiprazole has affinity (expressed as K i ) for multiple monoaminergic receptors including serotonin 5-HT 1A (0.12 nM), 5-HT 2A (0.47 nM), 5-HT 2B (1.9 nM), 5-HT 7 (3.7 nM), dopamine D 2 (0.30 nM), D 3 (1.1 nM), and noradrenergic α 1A (3.8 nM), α 1B (0.17 nM), α 1D (2.6 nM), and α 2C (0.59 nM) receptors. Brexpiprazole acts as a partial agonist at the 5-HT 1A , D 2 , and D 3 receptors and as an antagonist at 5-HT 2A , 5-HT 2B , 5-HT 7 , α 1A , α 1B , α 1D , and α 2C receptors. Brexpiprazole also exhibits affinity for histamine H 1 receptor (19 nM) and for muscarinic M 1 receptor (67% inhibition at 10 µM).

Cardiac Electrophysiology At a dose 3 times the MRHD for the treatment of schizophrenia and 4 times the MRHD for adjunctive therapy to antidepressants for the treatment of MDD or agitation associated with dementia due to Alzheimer's disease, REXULTI does not prolong the QTc interval to any clinically relevant extent.

12.3Pharmacokinetics Absorption After single-dose administration of REXULTI tablets, the peak plasma brexpiprazole concentrations occurred within 4 hours after administration, and the absolute oral bioavailability was 95%. Brexpiprazole steady-state concentrations were attained within 10 to 12 days of dosing. REXULTI can be administered with or without food.

Administration of a 4 mg REXULTI tablet with a standard high-fat meal did not significantly affect the C max or AUC of brexpiprazole. After single and multiple once daily dose administration, brexpiprazole exposure (C max and AUC) increased in proportion to the dose administered. In vitro studies of brexpiprazole did not indicate that brexpiprazole is a substrate of efflux transporters such as MDRI (P-gp) and BCRP.

Distribution The volume of distribution of brexpiprazole following intravenous administration is high (1.56 ±

0.42L/kg), indicating extravascular distribution. Brexpiprazole is highly protein bound in plasma (greater than 99%) to serum albumin and α1-acid glycoprotein, and its protein binding is not affected by renal or hepatic impairment. Based on results of in vitro studies, brexpiprazole protein binding is not affected by warfarin, diazepam, or digitoxin.

Elimination Metabolism Based on in vitro metabolism studies of brexpiprazole using recombinant human cytochrome P450 (CYP1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4), the metabolism of brexpiprazole was shown to be mainly mediated by CYP3A4 and CYP2D6. In vivo brexpiprazole is metabolized primarily by CYP3A4 and CYP2D6 enzymes. After single- and multiple-dose administrations, brexpiprazole and its major metabolite, DM-3411, were the predominant drug moieties in the systemic circulation.

At steady-state, DM-3411 represented 23% to 48% of brexpiprazole exposure (AUC) in plasma. DM-3411 is considered not to contribute to the therapeutic effects of brexpiprazole. Based on in vitro data, brexpiprazole showed little to no inhibition of CYP450 isozymes.

Excretion Following a single oral dose of [ 14 C]-labeled brexpiprazole, approximately 25% and 46% of the administered radioactivity was recovered in the urine and feces, respectively. Less than 1% of unchanged brexpiprazole was excreted in the urine, and approximately 14% of the oral dose was recovered unchanged in the feces. Apparent oral clearance of a brexpiprazole oral tablet after once daily administration is 19.8 (±11.4) mL/h/kg.

After multiple once-daily administrations of REXULTI, the terminal elimination half-lives of brexpiprazole and its major metab…

📦 How Supplied / Storage and Handling 197 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied REXULTI (brexpiprazole) tablets have markings on one side and are available in the following strengths and package configurations (see below): 0.25 mg tablets are light brown, round, shallow convex, bevel-edged body with "BRX" and "0.25" imprinted on one side NDC 59148-035-13 Bottles of 30 0.5 mg tablets: are light orange, round, shallow convex, bevel-edged body with "BRX" and "0.5" imprinted on one side NDC 59148-036-13 Bottles of 30 1 mg tablets are light yellow, round, shallow convex, bevel-edged body with "BRX" and "1" imprinted on one side NDC 59148-037-13 Bottles of 30 2 mg tablets are light green, round, shallow convex, bevel-edged body with "BRX" and "2" imprinted on one side NDC 59148-038-13 Bottles of 30 3 mg tablets are light purple, round, shallow convex, bevel-edged body with "BRX" and "3" imprinted on one side NDC 59148-039-13 Bottles of 30 4 mg tablets are white, round, shallow convex, bevel-edged body with "BRX" and "4" imprinted on one side NDC 59148-040-13 Bottles of 30 Storage and Handling Store REXULTI tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 27 words ▾

Storage and Handling Store REXULTI tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description 95 words ▾

11 DESCRIPTION Brexpiprazole, an atypical antipsychotic, is available as REXULTI ® (brexpiprazole) tablets. Brexpiprazole is 7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1 H )-one. The empirical formula is C 25 H 27 N 3 O 2 S, and its molecular weight is 433.57.

The chemical structure is: REXULTI tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths. Inactive ingredients include lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, and talc. Colorants include titanium dioxide, iron oxide, and ferrosoferric oxide.

Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning , Warnings and Precautions (5.2) ] . Dosage and Administration Advise patients that REXULTI can be taken with or without food.

Advise patients regarding importance of following dosage escalation instructions [see Dosage and Administration (2) ] . Neuroleptic Malignant Syndrome (NMS) Counsel patients about a potentially fatal adverse reaction, Neuroleptic Malignant Syndrome (NMS), that has been reported in association with administration of antipsychotic drugs. Advise patients to contact a healthcare provider or report to the emergency room if they experience signs or symptoms of NMS [see Warnings and Precautions (5.4) ].

Tardive Dyskinesia Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur [see Warnings and Precautions (5.5) ]. Metabolic Changes Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [see Warnings and Precautions (5.6) ]. Pathological Gambling and Other Compulsive Behaviors Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking REXULTI.

In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped [see Warnings and Precautions (5.7) ]. Leukopenia, Neutropenia and Agranulocytosis Advise patients with a pre-existing low WBC or a history of drug-induced leukopenia/neutropenia that they should have their CBC monitored while taking REXULTI [see Warnings and Precautions (5.8) ]. Orthostatic Hypotension and Syncope Educate patients about the risk of orthostatic hypotension and syncope, especially early in treatment, and also at times of reinitiating treatment or increases in dosage [see Warnings and Precautions (5.9) ].

Heat Exposure and Dehydration Counsel patients regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.12) ]. Potential for Cognitive and Motor Impairment Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that REXULTI therapy does not adversely affect their ability to engage in such activities [see Warnings and Precautions (5.14) ] . Concomitant Medications Advise patients to inform their healthcare providers of any changes to their current prescription or over-the-counter medications because there is a potential for clinically significant interactions [see Drug Interactions (7.1) ] .

Pregnancy Advise patients that third trimester use of REXULTI may cause extrapyramidal and/or withdrawal symptoms in a neonate and to notify their healthcare provider with a known or suspected pregnancy. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REXULTI during pregnancy [see Use in Specific Populations (8.1) ] .

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE REXULTI ® (REX-ul-TE) (brexpiprazole) tablets, for oral use This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 4/2026 What is the most important information I should know about REXULTI?

REXULTI may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. Medicines like REXULTI can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). REXULTI is not approved for the treatment of people with dementia-related psychosis without agitation that may happen with dementia due to Alzheimer's disease.

Increased risk of suicidal thoughts and actions. REXULTI and antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when REXULTI or the antidepressant medicine is started or when the dose is changed.

Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying new or worsening depression feeling very agitated or restless trouble sleeping (insomnia) acting aggressive, being angry, or violent an extreme increase in activity or talking (mania) suicide attempts new or worsening anxiety panic attacks new or worsening irritability acting on dangerous impulses other unusual changes in behavior or mood See " What are the possible side effects of REXULTI? " for more information about side effects.

What is REXULTI? REXULTI is a prescription medicine used: along with antidepressant medicines to treat major depressive disorder (MDD) in adults to treat schizophrenia in adults and children ages 13 years and older to treat agitation that may happen with dementia due to Alzheimer's disease REXULTI should not be used as an "as needed" treatment for agitation that may happen with dementia due to Alzheimer's disease. It is not known if REXULTI is safe and effective for the treatment of MDD in children.

It is not known if REXULTI is safe and effective for the treatment of schizophrenia in children under 13 years of age. Who should not take REXULTI? Do not take REXULTI if you are allergic to brexpiprazole or any of the ingredients in REXULTI.

See the end of this Medication Guide for a complete list of ingredients in REXULTI. Before taking REXULTI, tell your healthcare provider about all of your medical conditions, including if you: have or have had heart problems or a stroke have or have had low or high blood pressure have or have had diabetes or high blood sugar or a family history of diabetes or high blood sugar. have of have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol have or have had seizures (convulsions) have or have had kidney or liver problems have or have had a low white blood cell count are pregnant or plan to become pregnant.

REXULTI may harm your unborn baby. Taking REXULTI during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider ab…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59148-0037-13 · Otsuka 59148-0039-13 · Otsuka →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.