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Vraylar cariprazine 1.5 mg Capsule, Gelatin Coated — NDC 61874-0115-20 package photo

Vraylar cariprazine 1.5 mg Capsule, Gelatin Coated

by Allergan, Inc. · 2 BLISTER PACK in 1 CARTON (61874-115-20) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-11)
NDC 61874-0115-20
🏷️ FDA NDC (as labeled) 61874-115-20 billing pads the product segment with a zero
This package
Contains10 capsule, gelatin coated in 1 blister pack Cost per ea$50.85 NADAC Per package$1,016.91 / 20 capsules Pack sizes5 compare ↓
Also priced by: Medicaid pays $48.81/unit · Part D plans $52.32/unit — full pricing hub ↓
Also comes in: 7 capsules 61874-0115-07 7 capsules 61874-0115-17 30 capsules 61874-0115-30 30 capsules 61874-0115-31
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 3, 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) 61874-115-20
Product NDC 61874-115
11-digit billing NDC 61874011520
NCPDP billing unit EA — each (per item)
RxCUI 1667660, 1667666, 1667668, 1667670, 1667672, 1667674, 1667676, 1667678,
UNII F6RJL8B278
UPC 0361874250305
Application # NDA204370
SPL Set ID 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f
Established class (EPC) Atypical Antipsychotic
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-09-17
Route ORAL
Dosage form CAPSULE, GELATIN COATED
Substance CARIPRAZINE
GCN Seq No 074807
GCN 39579
HICL code 042552
Ingredient (HICL) Cariprazine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H8
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 2)
HIC3 code H8W
Therapeutic class — specific (HIC3) Antipsychotic-Atypical,D3/D2 Partial Ag-5Ht Mixed
AHFS code 28:16.08.04
AHFS class Atypical Antipsychotics
FDB label name VRAYLAR 1.5 MG CAPSULE
FDB brand name Vraylar
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 61874-115-20 — 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 → 61874-0115-20. 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

LabelerAllergan, Inc.
Application holderABBVIE INC
FDA applicationNDA204370 (NDA)
Labeler code61874
First marketedSep 2015
Product typeHuman Prescription Drug
Portfolio188 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 VRAYLAR 1.5 MG CAPSULE Ingredient Cariprazine Hcl
📖 What it is MedlinePlus · NLM

Cariprazine is used to treat schizophrenia (a mental illness that affects how a person thinks, feels and behaves), bipolar disorder (a disease that causes depression, mania, and other abnormal moods), and major depressive disorder. Cariprazine 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
  • Vraylar is used for a few different conditions depending on your age. For adults, it can treat schizophrenia, manic or mixed episodes of bipolar I disorder, the depressive episodes...
  • This one takes some patience. Vraylar and its active breakdown products build up in your system slowly — it can take a week or two to start noticing changes, and full effects may n...
  • How long does it take for Vraylar to start working?
  • The most common things people notice are a feeling of restlessness or the urge to keep moving (called akathisia), stiffness or tremor in the muscles, nausea, constipation, or fatig...
📖 Read our full Cariprazine 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 white / yellow / gray / green / blue / purple
ShapeCapsule
ImprintFL;3
Size14 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 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 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • 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 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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 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.

6 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 $50.846 $1,016.91 / 20 capsules
Medicaid paysCMS SDUD · 12 mo $48.81 $976.19 / 20 capsules
Medicare drug plans payPart D · Q2 2026 $52.32 $1,046.33 / 20 capsules
NADAC price history (per ea) — tap or hover for the price & month
Aug 2021 Jan 2024 May 2026 Aug 2026 $50.965 $40.559
▲ Up 25% 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
Vraylar 1.5 mgthis 61874-0115-20 Allergan, 10 capsules $50.846 — Availability likely —
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
Sep 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2030
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 Mar 2030. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 17, 2015 RLD RS ⏳ ~3.5 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 7737142 — drug substance (U-2544)
US 7737142 — drug substance (U-2545)
US RE47350 — method of use (U-1750)
US 7737142 — drug substance (U-2545)
US 7737142 — drug substance (U-2544)
US 7737142 — drug substance (U-1750)
US 7737142 — drug substance (U-2543)
US 7737142 — drug substance (U-1750)
US 7737142 — drug substance (U-2543)
US 7737142 — drug substance (U-1750)
US RE47350 — method of use (U-2543)
US 7737142 — drug substance (U-1750)
US 7737142 — drug substance (U-2543)
US 7737142 — drug substance (U-2544)
US 7737142 — drug substance (U-2544)
US RE49110 — method of use (U-2545)
US RE49110 — method of use (U-2544)
US RE49110 — method of use (U-2543)
US RE49110 — method of use (U-2545)
US RE49110 — method of use (U-2543)
US RE49110 — method of use (U-2544)
US RE49110 — method of use (U-2544)
US RE49110 — method of use (U-2543)
US RE49110 — method of use (U-2545)
US RE49110 — method of use (U-2545)
US RE49110 — method of use (U-2544)
US RE49110 — method of use (U-2543)
US 7737142 — drug substance (U-2543)
US 7737142 — drug substance (U-2544)
US 7737142 — drug substance (U-3503)
US 7737142 — drug substance (U-2545)
US 7737142 — drug substance (U-2543)
US 7737142 — drug substance (U-2544)
US 7737142 — drug substance (U-3503)
US 7737142 — drug substance (U-2545)
US RE49110 — method of use (U-2543)
US RE49110 — method of use (U-2544)
US RE49110 — method of use (U-2545)
US RE49110 — method of use (U-3503)
US RE49110 — method of use (U-2545)
US RE49110 — method of use (U-3503)
US RE49110 — method of use (U-2543)
US RE49110 — method of use (U-2544)
US RE47350 — method of use (U-2543)
US RE47350 — method of use (U-2544)
US RE47350 — method of use (U-3503)
US RE47350 — method of use (U-2545)
US RE47350 — method of use (U-2543)
US RE47350 — method of use (U-3503)
US RE47350 — method of use (U-2545)
US RE47350 — method of use (U-2544)
US RE47350 — method of use (U-3503)
US RE49110 — method of use (U-3503)
US 7737142 — drug substance (U-3503)
US 7737142 — drug substance (U-3503)
US RE49110 — method of use (U-3503)
US RE49302 — method of use (U-2543)
US RE49302 — method of use (U-2543)
US RE49302 — method of use (U-2543)
US RE49302 — method of use (U-2543)
US RE49302 — method of use (U-3503)
US RE49302 — method of use (U-2544)
US RE49302 — method of use (U-2545)
US RE49302 — method of use (U-2545)
US RE49302 — method of use (U-2544)
US RE49302 — method of use (U-3503)
US RE49302 — method of use (U-2544)
US RE49302 — method of use (U-3503)
US RE49302 — method of use (U-2545)
US RE49302 — method of use (U-2544)
US RE49302 — method of use (U-2545)
US RE49302 — method of use (U-3503)
US RE47350 — method of use (U-2544)
US RE47350 — method of use (U-2545)
US 7737142 — drug substance (U-2543)
US 7943621 — drug substance
US 7943621 — drug substance
US 7943621 — drug substance
US 7943621 — drug substance
US 7943621 — drug substance
US 7943621 — drug substance
US 7737142*PED — drug product
US 7943621*PED — drug product
US 7943621*PED — drug product
US 7737142*PED — drug product
US 7737142*PED — drug product
US 7943621*PED — drug product
US 7737142*PED — drug product
US 7943621*PED — drug product
US RE47350*PED — drug product
US RE49110*PED — drug product
US RE49110*PED — drug product
US RE47350*PED — drug product
US 7737142*PED — drug product
US 7737142*PED — drug product
US 7943621*PED — drug product
US 7943621*PED — drug product
US RE49302*PED — drug product
US RE49302*PED — drug product
US RE49302*PED — drug product
US RE49302*PED — drug product
US RE49110*PED — drug product
US RE49110*PED — drug product
US RE49110*PED — drug product
US RE49110*PED — drug product
US RE47350*PED — drug product
Exclusivity M-14
Exclusivity NPP
Exclusivity M-14
Exclusivity NPP
Exclusivity M-14
Exclusivity NPP
Exclusivity M-14
Exclusivity M-14
Exclusivity NPP
Exclusivity M-14
Exclusivity NPP
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
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 (106)
PatentTypeUse codeExpires
US 7737142 ↗ Drug substance U-2544 Sep 17, 2029
US 7737142 ↗ Drug substance U-2545 Sep 17, 2029
US RE47350 ↗ Method of use U-1750 Jul 16, 2029
US 7737142 ↗ Drug substance U-2545 Sep 17, 2029
US 7737142 ↗ Drug substance U-2544 Sep 17, 2029
US 7737142 ↗ Drug substance U-1750 Sep 17, 2029
US 7737142 ↗ Drug substance U-2543 Sep 17, 2029
US 7737142 ↗ Drug substance U-1750 Sep 17, 2029
US 7737142 ↗ Drug substance U-2543 Sep 17, 2029
US 7737142 ↗ Drug substance U-1750 Sep 17, 2029
US RE47350 ↗ Method of use U-2543 Jul 16, 2029
US 7737142 ↗ Drug substance U-1750 Sep 17, 2029
US 7737142 ↗ Drug substance U-2543 Sep 17, 2029
US 7737142 ↗ Drug substance U-2544 Sep 17, 2029
US 7737142 ↗ Drug substance U-2544 Sep 17, 2029
US RE49110 ↗ Method of use U-2545 Jul 16, 2029
US RE49110 ↗ Method of use U-2544 Jul 16, 2029
US RE49110 ↗ Method of use U-2543 Jul 16, 2029
US RE49110 ↗ Method of use U-2545 Jul 16, 2029
US RE49110 ↗ Method of use U-2543 Jul 16, 2029
US RE49110 ↗ Method of use U-2544 Jul 16, 2029
US RE49110 ↗ Method of use U-2544 Jul 16, 2029
US RE49110 ↗ Method of use U-2543 Jul 16, 2029
US RE49110 ↗ Method of use U-2545 Jul 16, 2029
US RE49110 ↗ Method of use U-2545 Jul 16, 2029
US RE49110 ↗ Method of use U-2544 Jul 16, 2029
US RE49110 ↗ Method of use U-2543 Jul 16, 2029
US 7737142 ↗ Drug substance U-2543 Sep 17, 2029
US 7737142 ↗ Drug substance U-2544 Sep 17, 2029
US 7737142 ↗ Drug substance U-3503 Sep 17, 2029
US 7737142 ↗ Drug substance U-2545 Sep 17, 2029
US 7737142 ↗ Drug substance U-2543 Sep 17, 2029
US 7737142 ↗ Drug substance U-2544 Sep 17, 2029
US 7737142 ↗ Drug substance U-3503 Sep 17, 2029
US 7737142 ↗ Drug substance U-2545 Sep 17, 2029
US RE49110 ↗ Method of use U-2543 Jul 16, 2029
US RE49110 ↗ Method of use U-2544 Jul 16, 2029
US RE49110 ↗ Method of use U-2545 Jul 16, 2029
US RE49110 ↗ Method of use U-3503 Jul 16, 2029
US RE49110 ↗ Method of use U-2545 Jul 16, 2029
US RE49110 ↗ Method of use U-3503 Jul 16, 2029
US RE49110 ↗ Method of use U-2543 Jul 16, 2029
US RE49110 ↗ Method of use U-2544 Jul 16, 2029
US RE47350 ↗ Method of use U-2543 Jul 16, 2029
US RE47350 ↗ Method of use U-2544 Jul 16, 2029
US RE47350 ↗ Method of use U-3503 Jul 16, 2029
US RE47350 ↗ Method of use U-2545 Jul 16, 2029
US RE47350 ↗ Method of use U-2543 Jul 16, 2029
US RE47350 ↗ Method of use U-3503 Jul 16, 2029
US RE47350 ↗ Method of use U-2545 Jul 16, 2029
US RE47350 ↗ Method of use U-2544 Jul 16, 2029
US RE47350 ↗ Method of use U-3503 Jul 16, 2029
US RE49110 ↗ Method of use U-3503 Jul 16, 2029
US 7737142 ↗ Drug substance U-3503 Sep 17, 2029
US 7737142 ↗ Drug substance U-3503 Sep 17, 2029
US RE49110 ↗ Method of use U-3503 Jul 16, 2029
US RE49302 ↗ Method of use U-2543 Jul 16, 2029
US RE49302 ↗ Method of use U-2543 Jul 16, 2029
US RE49302 ↗ Method of use U-2543 Jul 16, 2029
US RE49302 ↗ Method of use U-2543 Jul 16, 2029
US RE49302 ↗ Method of use U-3503 Jul 16, 2029
US RE49302 ↗ Method of use U-2544 Jul 16, 2029
US RE49302 ↗ Method of use U-2545 Jul 16, 2029
US RE49302 ↗ Method of use U-2545 Jul 16, 2029
US RE49302 ↗ Method of use U-2544 Jul 16, 2029
US RE49302 ↗ Method of use U-3503 Jul 16, 2029
US RE49302 ↗ Method of use U-2544 Jul 16, 2029
US RE49302 ↗ Method of use U-3503 Jul 16, 2029
US RE49302 ↗ Method of use U-2545 Jul 16, 2029
US RE49302 ↗ Method of use U-2544 Jul 16, 2029
US RE49302 ↗ Method of use U-2545 Jul 16, 2029
US RE49302 ↗ Method of use U-3503 Jul 16, 2029
US RE47350 ↗ Method of use U-2544 Jul 16, 2029
US RE47350 ↗ Method of use U-2545 Jul 16, 2029
US 7737142 ↗ Drug substance U-2543 Sep 17, 2029
US 7943621 ↗ Drug substance — Dec 20, 2028
US 7943621 ↗ Drug substance — Dec 16, 2028
US 7943621 ↗ Drug substance — Dec 16, 2028
US 7943621 ↗ Drug substance — Dec 20, 2028
US 7943621 ↗ Drug substance — Dec 16, 2028
US 7943621 ↗ Drug substance — Dec 16, 2028
US 7737142*PED ↗ Drug product — Mar 17, 2030
US 7943621*PED ↗ Drug product — Jun 16, 2029
US 7943621*PED ↗ Drug product — Jun 16, 2029
US 7737142*PED ↗ Drug product — Mar 17, 2030
US 7737142*PED ↗ Drug product — Mar 17, 2030
US 7943621*PED ↗ Drug product — Jun 16, 2029
US 7737142*PED ↗ Drug product — Mar 17, 2030
US 7943621*PED ↗ Drug product — Jun 16, 2029
US RE47350*PED ↗ Drug product — Jan 16, 2030
US RE49110*PED ↗ Drug product — Jan 16, 2030
US RE49110*PED ↗ Drug product — Jan 16, 2030
US RE47350*PED ↗ Drug product — Jan 16, 2030
US 7737142*PED ↗ Drug product — Mar 17, 2030
US 7737142*PED ↗ Drug product — Mar 17, 2030
US 7943621*PED ↗ Drug product — Jun 20, 2029
US 7943621*PED ↗ Drug product — Jun 20, 2029
US RE49302*PED ↗ Drug product — Jan 16, 2030
US RE49302*PED ↗ Drug product — Jan 16, 2030
US RE49302*PED ↗ Drug product — Jan 16, 2030
US RE49302*PED ↗ Drug product — Jan 16, 2030
US RE49110*PED ↗ Drug product — Jan 16, 2030
US RE49110*PED ↗ Drug product — Jan 16, 2030
US RE49110*PED ↗ Drug product — Jan 16, 2030
US RE49110*PED ↗ Drug product — Jan 16, 2030
US RE47350*PED ↗ Drug product — Jan 16, 2030
FDA exclusivity
CodeWhat it grantsExpires
M-14New indication / labeling change (3-year)Dec 18, 2028
NPPNew Patient PopulationDec 18, 2028
M-14New indication / labeling change (3-year)Dec 18, 2028
NPPNew Patient PopulationDec 18, 2028
M-14New indication / labeling change (3-year)Dec 18, 2028
NPPNew Patient PopulationDec 18, 2028
M-14New indication / labeling change (3-year)Dec 18, 2028
M-14New indication / labeling change (3-year)Dec 18, 2028
NPPNew Patient PopulationDec 18, 2028
M-14New indication / labeling change (3-year)Dec 18, 2028
NPPNew Patient PopulationDec 18, 2028
PEDPediatric Exclusivity (+6 months)Jun 18, 2029
PEDPediatric Exclusivity (+6 months)Jun 18, 2029
PEDPediatric Exclusivity (+6 months)Jun 18, 2029
PEDPediatric Exclusivity (+6 months)Jun 18, 2029
PEDPediatric Exclusivity (+6 months)Jun 18, 2029
PEDPediatric Exclusivity (+6 months)Jun 18, 2029
PEDPediatric Exclusivity (+6 months)Jun 18, 2029
PEDPediatric Exclusivity (+6 months)Jun 18, 2029
PEDPediatric Exclusivity (+6 months)Jun 18, 2029
PEDPediatric Exclusivity (+6 months)Jun 18, 2029
PEDPediatric Exclusivity (+6 months)Jun 18, 2029
Common questions
Is there a generic version of VRAYLAR 1.5 MG CAPSULE?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for VRAYLAR 1.5 MG CAPSULE. 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 61874-0115-20, 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
5.6K
Units reimbursed last 4 qtrs
139.2K
Gross reimbursed last 4 qtrs
$6.79M
Avg / prescription
$1,203.16
Avg / unit
$48.8096
Latest quarter Q4 2025
918Rx
Medicaid pays / ea
$48.8096
gross reimbursed
vs
NADAC / ea
$50.8455
acquisition cost
=
Spread
−$2.0359
-4% 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 ⓘ
39% FFS 61% MCO
Fee-for-service · 2,198 Rx Managed care · 3,448 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 705 units · 35.9 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 1,280 units · 22.3 per 100k residents MN Wisconsin: 9,956 units · 168 per 100k residents WI Michigan: 7,385 units · 73.6 per 100k residents MI New York: 6,315 units · 32.3 per 100k residents NY Vermont: no data reported VT New Hampshire: 300 units · 21.4 per 100k residents NH Oregon: 649 units · 15.3 per 100k residents OR Nevada: 1,388 units · 43.5 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,368 units · 42.7 per 100k residents IA Illinois: 6,329 units · 50.4 per 100k residents IL Indiana: 2,785 units · 40.6 per 100k residents IN Ohio: 9,313 units · 79.0 per 100k residents OH Pennsylvania: 749 units · 5.8 per 100k residents PA New Jersey: 1,116 units · 12.0 per 100k residents NJ Massachusetts: 2,255 units · 32.2 per 100k residents MA California: 5,714 units · 14.7 per 100k residents CA Utah: no data reported UT Colorado: 5,216 units · 88.7 per 100k residents CO Nebraska: 1,217 units · 61.5 per 100k residents NE Missouri: 3,098 units · 50.0 per 100k residents MO Kentucky: 13,965 units · 309 per 100k residents KY West Virginia: 1,714 units · 96.8 per 100k residents WV Virginia: 2,720 units · 31.2 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 769 units · 26.2 per 100k residents KS Arkansas: no data reported AR Tennessee: 11,256 units · 158 per 100k residents TN North Carolina: 18,634 units · 172 per 100k residents NC South Carolina: 1,325 units · 24.7 per 100k residents SC Delaware: 1,222 units · 119 per 100k residents DE Oklahoma: 744 units · 18.4 per 100k residents OK Louisiana: 13,771 units · 301 per 100k residents LA Mississippi: 672 units · 22.9 per 100k residents MS Alabama: no data reported AL Georgia: 570 units · 5.2 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 2,448 units · 8.0 per 100k residents TX Florida: 2,226 units · 9.8 per 100k residents FL
Units reimbursed · per 100k residents
5.2309
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 Kentucky 309 /100k
2 Louisiana 301 /100k
3 North Carolina 172 /100k
4 Wisconsin 168 /100k
5 Tennessee 158 /100k
6 Delaware 119 /100k
7 West Virginia 96.8 /100k
8 Colorado 88.7 /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 capsules61874-0115-30 474,575 Rx · $707,775,720
10 capsules this page61874-0115-20 4,522 Rx · $5,334,240
7 capsules61874-0115-07 No Medicaid data
7 capsules61874-0115-17 No Medicaid data
30 capsules61874-0115-31 No Medicaid data
Drug total (last 4 qtrs): 479,097 Rx · 14,520,833 units · $713,109,960 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 Vraylar — the program that covers self-administered drugs. 2 manufacturers.
⚠️ 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 Vraylar. 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
$328.87M
Claims incl. refills
210.8K
Beneficiaries
85.9K
Spend / beneficiary
$3,830.57
Spend / claim
$1,559.86
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
61874-0115-07 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-07) — — 2016-03-01 Active
61874-0115-17 1 BLISTER PACK in 1 CARTON (61874-115-17) / 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK — — 2016-03-01 Active
61874-0115-20 You're viewing this 2 BLISTER PACK in 1 CARTON (61874-115-20) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-11) $50.85 / ea $1,016.91 2016-03-01 Active
61874-0115-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-115-30) $50.85 / ea $1,525.37 2016-03-01 Active
61874-0115-31 5 CARTON in 1 TRAY (61874-115-31) / 1 BOTTLE in 1 CARTON / 30 CAPSULE, GELATIN COATED in 1 BOTTLE — — 2016-03-01 Discontinued by firm

This pack has the lowest per-ea cost of the 2 priced pack sizes ($50.85 NADAC).

This pack accounts for about 0.9% of this product's recent Medicaid fills; most go to the 30 capsules pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 61874-0115-20?
NDC 61874-0115-20 is listed by the FDA — 2 blister pack in 1 carton / 10 capsule, gelatin coated in 1 blister pack.
What NDC number is used to bill for this package of Vraylar cariprazine 1.5 mg Capsule, Gelatin Coated?
Bill NDC 61874-0115-20 — the 11-digit billing format is 61874011520. 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 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 191 words ▾

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS 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. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.

Closely monitor all antidepressant-treated patients for clinical worsening, and for the emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.2 )] . 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 an increased risk of death.

VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. ( 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.

( 5.2 )

🎯 Indications and Usage 187 words ▾

1 . INDICATIONS AND USAGE VRAYLAR ® is indicated for: • Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies ( 14.1 )] • Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies ( 14.2 )] • Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies ( 14.3 )] • Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies ( 14.4 )] VRAYLAR is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults and pediatric patients 13 years of age and older ( 1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and pediatric patients 10 years of age and older ( 1 ) Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults ( 1 ) Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 . DOSAGE AND ADMINISTRATION Administer VRAYLAR orally once daily with or without food ( 2 ) Starting Dose Recommended Dose Schizophrenia in Adults ( 2.2 ) 1.5 mg daily 1.5 mg to 6 mg daily Schizophrenia in Pediatric Patients (13-17 years) ( 2.2 ) 0.5 mg daily 1.5 mg to 4.5 mg daily Bipolar Mania in Adults ( 2.3 ) 1.5 mg daily 3 mg to 6 mg daily Bipolar Mania in Pediatric Patients (10-17 years) ( 2.3 ) 0.5 mg daily 3 mg or 4.5 mg daily Bipolar Depression in Adults ( 2.4 ) 1.5 mg daily 1.5 mg or 3 mg daily Adjunctive therapy to antidepressants for MDD in Adults ( 2.5 ) 1.5 mg daily 1.5 mg or 3 mg daily Adults with Schizophrenia and Bipolar Mania: Maximum recommended daily dosage is 6 mg.

Dosages above 6 mg daily do not confer significant benefit, but increase the risk of dose-related adverse reactions ( 2.2 , 2.3 ) Pediatric patients with Schizophrenia and Bipolar Mania: Maximum recommended daily dosage is 4.5 mg. Adults with Bipolar Depression: Maximum recommended daily dosage is 3 mg ( 2.4 ) Adjunctive therapy for treatment of MDD in Adults: Maximum recommended daily dosage is 3 mg ( 2.5 )

2.1General Dosing Information VRAYLAR is given orally once daily and can be taken with or without food. Because of the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks. Prescribers should monitor patients for adverse reactions and treatment response for several weeks after starting VRAYLAR and after each dosage change [see Warnings and Precautions ( 5.6 ) , Clinical Pharmacology ( 12.3 )] .

2.2Recommended Dosage in Schizophrenia Adult Patients The starting dosage of VRAYLAR is 1.5 mg orally once daily. The recommended dosage range is 1.5 mg to 6 mg orally once daily. The dosage can be increased to 3 mg on Day 2.

Depending upon clinical response and tolerability, further dose adjustments can be made in 1.5 mg or 3 mg increments. The maximum recommended dosage is 6 mg orally once daily. In short-term controlled trials, dosages above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.1 )] .

Pediatric Patients (13 to 17 years of age) The starting dosage of VRAYLAR is 0.5 mg orally once daily. The recommended dosage range is 1.5 mg to 4.5 mg orally once daily. Increase the dosage to 1.5 mg orally once daily on Day 3.

Depending upon clinical response and tolerability, the dosage may be increased to 3 mg orally once daily starting on Day 5, and to 4.5 mg orally once daily starting on Day 8. The maximum recommended dosage is 4.5 mg orally once daily.

2.3Recommended Dosage in Manic or M ixed E pisodes Associated with Bipolar I Disorder Adult Patients The starting dosage of VRAYLAR is 1.5 mg orally once daily. Increase the dosage to 3 mg orally once daily on Day 2. The recommended dosage range is 3 mg to 6 mg orally once daily.

Depending upon clinical response and tolerability, further dose adjustments can be made in 1.5 mg or 3 mg increments. The maximum recommended dosage is 6 mg orally once daily. In short-term controlled trials, dosages above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions [ see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.2 ) ] .

Pediatric Patients (10 to 17 years of age)​ The starting dosage of VRAYLAR is 0.5 mg orally once daily. The recommended dosage is 3 mg or 4.5 mg orally once daily. Increase the dosage to 1.5 mg orally once daily on Day 3 and to 3 mg orally once daily on Day 5.

Depending upon clinical response and tolerability, the dosage may be increased to 4.5 mg orally once daily starting on Day 8. The maximum recommended dosage is 4.5 mg orally once daily.

2.4Recommended Dosage in Depressive Episodes Associated with Bipolar I Disorder (Bipolar Depression) in Adult Patients The starting dosage of VRAYLAR is 1.5 mg orally once daily. Depending upon clinical response and to…

💊 Dosage Forms and Strengths 112 words ▾

3 . DOSAGE FORMS AND STRENGTHS VRAYLAR (cariprazine) capsules are available in six strengths. 0.5 mg capsules: Ivory to yellow cap and a grey to green body imprinted with “FL 0.5” 0.75 mg capsules: Grey to green cap and blue body imprinted with “FL 0.75” 1.5 mg capsules: White cap and body imprinted with “FL 1.5” 3 mg capsules: Green to blue-green cap and white body imprinted with “FL 3” 4.5 mg capsules: Green to blue-green cap and body imprinted with “FL 4.5” 6 mg capsules: Purple cap and white body imprinted with “FL 6” Capsules: 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, and 6 mg ( 3 )

⛔ Contraindications 47 words ▾

4 . CONTRAINDICATIONS VRAYLAR is contraindicated in patients with history of a hypersensitivity reaction to cariprazine. Reactions have ranged from rash, pruritus, urticaria, and reactions suggestive of angioedema (e.g., swollen tongue, lip swelling, face edema, pharyngeal edema, and swelling face). Known hypersensitivity to VRAYLAR ( 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 appropriate ( 5.5 ) Late-Occurring Adverse Reactions: Because of VRAYLAR’s long half-life, monitor for adverse reactions and patient response for several weeks after starting VRAYLAR and with each dosage change ( 5.6 ) Metabolic Changes : Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain ( 5.7 ) Leukopenia, Neutropenia, and Agranulocytosis : Perform complete blood counts (CBC) in patients with pre-existing low white blood cell counts (WBC) or history of leukopenia or neutropenia.

Consider discontinuing VRAYLAR if a clinically significant decline in WBC occurs in absence of other causative factors ( 5.8 ) Orthostatic H ypotension 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 ( 5.12 )

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

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. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis [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 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 3. Table 3: Risk Differences of the Number of Patients of Suicidal Thoughts and Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18-24 years old 5 additional patients Decreases Compared to Placebo 25-64 years old 1 fewer patient ≥65 years old 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 trials in adults…

🤒 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 and Warnings and Precautions ( 5.1 )] Suicidal Thoughts and Behaviors [see Boxed Warning and 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 [see Warnings and Precautions ( 5.4 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] Late Occurring Adverse Reactions [see Warnings and Precautions ( 5.6 )] Metabolic Changes [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 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.12 )] Body Temperature Dysregulation [see Warnings and Precautions ( 5.13 )] Dysphagia [see Warnings and Precautions ( 5.14 )] Most common adverse reactions in adults (incidence ≥ 5% and at least twice the rate of placebo) were ( 6.1 ) : Schizophrenia: extrapyramidal symptoms and akathisia Bipolar mania: extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness Bipolar depression: nausea, akathisia, restlessness, and extrapyramidal symptoms Adjunctive treatment of MDD: akathisia, restlessness, fatigue, constipation, nausea, insomnia, increased appetite, dizziness, and extrapyramidal symptoms To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 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 practice. The information below is derived from an integrated clinical study database for VRAYLAR consisting of 6,722 adult patients exposed to one or more doses of VRAYLAR for the treatment of schizophrenia, manic or mixed episodes associated with bipolar I disorder, bipolar depression, and adjunctive treatment of major depressive disorder in placebo-controlled studies.

This experience corresponds with a total experience of 1,182.8 patient-years. A total of 4,329 VRAYLAR-treated patients had at least 6 weeks and 296 VRAYLAR-treated patients had at least 48 weeks of exposure. Adult Patients with Schizophrenia The following findings are based on four placebo-controlled, 6-week schizophrenia trials with VRAYLAR doses ranging from 1.5 to 12 mg once daily.

The maximum recommended dosage is 6 mg daily. Adverse Reactions Associated with Discontinuation of Treatment : There was no single adverse reaction leading to discontinuation that occurred at a rate of ≥ 2% in VRAYLAR-treated patients and at least twice the rate of placebo. Common Adverse Reactions (≥ 5% and at least twice the rate of placebo) : extrapyramidal symptoms and akathisia.

Adverse Reactions with an incidence of ≥ 2% and greater than placebo, at any dose are shown in Table 8. Table 8. Adverse Reactions Occurring in ≥ 2% of VRAYLAR-treated Patients and > Placebo-treated Adult Patients in 6-Week Schizophrenia Trials VRAYLAR * System Organ Class / Preferred Term Placebo (N= 584) (%) 1.5 to 3 mg/day (N=539) (%) 4.5 to 6 mg/day (N=575) (%) 9 to 12 mg/day ⸰ (N=203) (%) Cardiac Disorder s Tachycardia a 1 2 2 3 Gastrointestinal Disorders Abdominal pain b 5 3 4 7 Constipation 5 6 7 10 Diarrhea c 3 1 4 5 Dry Mouth 2 1 2 3 Dyspepsia 4 4 5 5 Nausea 5 5 7 8 Toothache 4 3 3 6 Vomiting 3 4 5 5 General Disorders/Administration Site Conditions Fatigue d 1 1 3 2 Infections and Infestations Nasopharyngitis 1 1 1 2 Urinary tra…

🔄 Drug Interactions 182 words ▾

7 DRUG INTERACTIONS Table 15 displays clinically significant drug interactions with VRAYLAR. Table 15. Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ].

Intervention: If VRAYLAR is used with a strong or moderate CYP3A4 inhibitor, reduce VRAYLAR dosage [see D osage and A dministration ( 2.6 ) ] . CYP3A4 Inducers Clinical Impact: CYP3A4 is responsible for the formation and elimination of the active metabolites of cariprazine. The effect of CYP3A4 inducers on the exposure of VRAYLAR has not been evaluated, and the net effect is unclear [see Clinical Pharmacology ( 12.3 ) ].

Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . Strong and Moderate CYP3A4 inhibitors: Reduce VRAYLAR dosage ( 2.6 , 7 ) CYP3A4 inducers: Concomitant use is not recommended ( 2.6 , 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Based on animal data, may cause fetal harm. ( 8.1 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VRAYLAR during pregnancy. For more information, contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations).

There are no available data on VRAYLAR use in pregnant women to inform any drug-associated risks for birth defects or miscarriage. The major active metabolite of cariprazine, DDCAR, has been detected in adult patients up to 12 weeks after discontinuation of VRAYLAR [see Clinical Pharmacology ( 12.3 )]. Based on animal data, VRAYLAR may cause fetal harm.

Administration of cariprazine to rats during the period of organogenesis caused malformations, lower pup survival, and developmental delays at drug exposures less than the human exposure at the maximum recommended human dose (MRHD) of 6 mg/day. However, cariprazine was not teratogenic in rabbits at doses up to 4.6 times the MRHD of 6 mg/day [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Advise pregnant women of the potential risk to a fetus. 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 Administration of cariprazine to pregnant rats during the period of organogenesis at oral doses of 0.5, 2.5, and 7.5 mg/kg/day, which are 0.2 to 3.5 times the maximum recommended human dose (MRHD) of 6 mg/day based on AUC of total cariprazine (i.e. sum of cariprazine, DCAR, and DDCAR), caused fetal developmental toxicity at all doses, which included reduced body weight, decreased male anogenital distance, and skeletal malformations of bent limb bones, scapula, and humerus. These effects occurred in the absence or presence of maternal toxicity.

Maternal toxicity, observed as a reduction in body weight and food consumption, occurred at doses 1.2 and 3.5-times the MRHD of 6 mg/day based on AUC of total cariprazine. At these doses, cariprazine caused fetal external malformations (localized fetal thoracic edema), visceral variations (undeveloped/underdeveloped renal papillae and/or distended urethrae), and skeletal developmental variations (bent ribs, unossified sternebrae). Cariprazine had no effect on fetal survival.

Administration of cariprazine to pregnant rats during pregnancy and lactation at oral doses of 0.1, 0.3, and 1 mg/kg/day, which are 0.03 to 0.4 times the MRHD of 6 mg/day based on AUC of total cariprazine, caused a decrease in postnatal survival, birth weight, and post-weaning body weight of first generation pups at the dose that is 0.4 times the MRHD of 6 mg/day based on AUC of total cariprazine in absence of maternal toxicity. First generation pups also had pale, cold bodies and developmental delays (renal papillae not developed or underdeveloped and decreased auditory startle response in males).

Reproductive performance of the first generation pups was un…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VRAYLAR during pregnancy. For more information, contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations).

There are no available data on VRAYLAR use in pregnant women to inform any drug-associated risks for birth defects or miscarriage. The major active metabolite of cariprazine, DDCAR, has been detected in adult patients up to 12 weeks after discontinuation of VRAYLAR [see Clinical Pharmacology ( 12.3 )]. Based on animal data, VRAYLAR may cause fetal harm.

Administration of cariprazine to rats during the period of organogenesis caused malformations, lower pup survival, and developmental delays at drug exposures less than the human exposure at the maximum recommended human dose (MRHD) of 6 mg/day. However, cariprazine was not teratogenic in rabbits at doses up to 4.6 times the MRHD of 6 mg/day [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Advise pregnant women of the potential risk to a fetus. 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 Administration of cariprazine to pregnant rats during the period of organogenesis at oral doses of 0.5, 2.5, and 7.5 mg/kg/day, which are 0.2 to 3.5 times the maximum recommended human dose (MRHD) of 6 mg/day based on AUC of total cariprazine (i.e. sum of cariprazine, DCAR, and DDCAR), caused fetal developmental toxicity at all doses, which included reduced body weight, decreased male anogenital distance, and skeletal malformations of bent limb bones, scapula, and humerus. These effects occurred in the absence or presence of maternal toxicity.

Maternal toxicity, observed as a reduction in body weight and food consumption, occurred at doses 1.2 and 3.5-times the MRHD of 6 mg/day based on AUC of total cariprazine. At these doses, cariprazine caused fetal external malformations (localized fetal thoracic edema), visceral variations (undeveloped/underdeveloped renal papillae and/or distended urethrae), and skeletal developmental variations (bent ribs, unossified sternebrae). Cariprazine had no effect on fetal survival.

Administration of cariprazine to pregnant rats during pregnancy and lactation at oral doses of 0.1, 0.3, and 1 mg/kg/day, which are 0.03 to 0.4 times the MRHD of 6 mg/day based on AUC of total cariprazine, caused a decrease in postnatal survival, birth weight, and post-weaning body weight of first generation pups at the dose that is 0.4 times the MRHD of 6 mg/day based on AUC of total cariprazine in absence of maternal toxicity. First generation pups also had pale, cold bodies and developmental delays (renal papillae not developed or underdeveloped and decreased auditory startle response in males).

Reproductive performance of the first generation pups was unaffected; however, the second generation pups had clinical signs and lower body weight similar…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Schizophrenia The safety and effectiveness of VRAYLAR for treatment of schizophrenia have been established in pediatric patients 13 years of age and older. Use of VRAYLAR in this population is supported by evidence from adequate and well-controlled studies in adults 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 ( 5.7 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 )] .

The safety and effectiveness of VRAYLAR for the treatment of schizophrenia have not been established in pediatric patients less than 13 years of age. Manic and Mixed Episodes Associated with Bipolar I Disorder The safety and effectiveness of VRAYLAR for treatment of manic and mixed episodes associated with bipolar I disorder have been established in pediatric patients 10 years of age and older. Use of VRAYLAR in this population is supported by evidence from adequate and well-controlled studies in adults with manic and mixed episodes associated with bipolar I disorder, pharmacokinetic data from adult and pediatric patients, and safety data in pediatric patients 10 to 17 years of age [see Warnings and Precautions ( 5.7 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 )] .

The safety and effectiveness of VRAYLAR for the treatment of manic and mixed episodes associated with bipolar I disorder have not been established in pediatric patients less than 10 years of age. Bipolar Depression The safety and effectiveness of VRAYLAR for treatment of bipolar depression in pediatric patients have not been established. Adjunctive Therapy for Treatment of MDD The safety and effectiveness of VRAYLAR as adjunctive therapy for treatment of MDD in pediatric patients have not been established.

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 VRAYLAR for the treatment of irritability associated with autism spectrum disorder in pediatric patients have not been established. In a single, 8-week, double-blind, placebo-controlled, flexible-dose clinical study conducted in 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, 5th Edition [DSM-5] criteria, a total of 161 patients were enrolled, of which 76 patients received cariprazine and 79 received placebo.

In this study, patients 5 to 9 years of age who were randomized to active treatment received cariprazine oral solution, which is not an approved formulation. Somnolence, including sedation, occurred in 18% of cariprazine-treated compared to 1% of placebo-treated pediatric patients and was observed at a higher rate than reported in other VRAYLAR studies evaluating adult patients. The mean increase in age-and-sex adjusted body weight z-score from baseline to last visit was 0.2 for cariprazine-treated versus less than 0.1 for placebo-treated pediatric patients.

Increases in age- and sex-adjusted body weight z-score of at least

0.5SD from baseline was higher in cariprazine-treated versus placebo-treated pediatric patients (19% versus 1%). In a long term, open-label study in pediatric patients 5 to 17 years of age with irritability associated with autism spectrum disorder, the mean change in weight from baseline to last available visit was 5.3 kg; two patients discontinued due to increased weight. When body weight was adjusted for age and sex, the mean z-score change from baseline to last visit was 0.4 for cariprazine-treated patients, and 32% of patients had an increase in age- and sex-adjusted body weight z-score of at least

0.5SD from baseline. Juvenile Animal Studies Juvenile rats were administered cariprazine at doses of 1, 3 and 10 mg/kg/day by oral gavage from days 28 to 90 of…

🧓 Geriatric Use 109 words ▾

8.5Geriatric Use Clinical trials of VRAYLAR did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Antipsychotic drugs increase the risk of death in elderly patients with dementia-related psychosis.

VRAYLAR is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning and Warning s and Precautions ( 5.1 , 5.3 ) ] .

🆘 Overdosage 89 words ▾

10 OVERDOSAGE

10.1Human Experience In pre-marketing clinical trials involving VRAYLAR in approximately 5000 patients or healthy subjects, accidental acute overdosage (48 mg/day) was reported in one patient. This patient experienced orthostasis and sedation. The patient fully recovered the same day.

10.2Management of Overdosage No specific antidotes for VRAYLAR are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. In case of an overdose, consult a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice.

🧬 Clinical Pharmacology ~3 min read ▾

12 . CLINICAL PHARMACOLOGY Figure 1. Plasma Concentration (Mean ± SE)-Time Profile During and Following 12-weeks of Treatment with Cariprazine 6 mg/daya

12.1Mechanism of Action The mechanism of action of cariprazine is unknown. However, the efficacy of cariprazine could be mediated through a combination of partial agonist activity at central dopamine D 2 and serotonin 5-HT 1A receptors and antagonist activity at serotonin 5-HT 2A receptors. Cariprazine forms two major metabolites, desmethylcariprazine (DCAR) and didesmethylcariprazine (DDCAR), that have in vitro receptor binding profiles similar to the parent drug.

12.2Pharmacodynamics Cariprazine acts as a partial agonist at the dopamine D 3 and D 2 receptors with high binding affinity (K i values 0.085 nM, and 0.49 nM (D 2L ) and 0.69 nM (D 2S ), respectively) and at the serotonin 5-HT 1A receptors (K i value 2.6 nM). Cariprazine acts as an antagonist at 5-HT 2 B and 5-HT 2A receptors with high and moderate binding affinity (Ki values 0.58 nM and 18.8 nM respectively) as well as it binds to the histamine H 1 receptors (K i value 23.2 nM). Cariprazine shows lower binding affinity to the serotonin 5-HT 2C and α 1 A - adrenergic receptors (K i values 134 nM and 155 nM, respectively) and has no appreciable affinity for cholinergic muscarinic receptors (IC 50 >1000 nM).

Effect on QTc Interval At a dose three times the maximum recommended dose, cariprazine does not prolong the QTc interval to clinically relevant extent.

12.3Pharmacokinetics VRAYLAR activity is thought to be mediated by cariprazine and its two major active metabolites, desmethylcariprazine (DCAR) and didesmethylcariprazine (DDCAR), which are pharmacologically equipotent to cariprazine. After multiple dose administration of VRAYLAR, mean cariprazine and DCAR concentrations reached steady state at around Week 1 to Week 2 and mean DDCAR concentrations appeared to be approaching steady state at around Week 4 to Week 8 in a 12-week study (Figure 1). The half-lives based on time to reach steady state, estimated from the mean concentration-time curves, are 2 to 4 days for cariprazine, about 1 to 2 days for DCAR, and approximately 1 to 3 weeks for DDCAR.

The time to reach steady state for the major active metabolite DDCAR was variable across patients, with some patients not achieving steady state at the end of the 12 week treatment [ s ee Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.6 ) ] . Mean concentrations of DCAR and DDCAR are approximately 30% and 400%, respectively, of cariprazine concentrations by the end of 12-week treatment. After discontinuation of VRAYLAR, cariprazine, DCAR, and DDCAR plasma concentrations declined in a multi-exponential manner.

Mean plasma concentrations of DDCAR decreased by about 50% 1 week after the last dose, and mean cariprazine and DCAR concentration dropped by about 50% in about 1 day. There was an approximately 90% decline in plasma exposure within 1 week for cariprazine and DCAR, and at about 4 weeks for DDCAR. Following a single dose of 1 mg of cariprazine administration, DDCAR remained detectable 8 weeks post-dose.

After multiple dosing of VRAYLAR, plasma exposure of cariprazine, DCAR, and DDCAR increases approximately proportionally over the therapeutic dose range. Figure 1 . Plasma Concentration (Mean ± SE) -Time Profile During and Following 12-weeks of Treatment with Cariprazine 6 mg/day a a Trough concentrations shown during treatment with cariprazine 6 mg/day.

SE: standard error; TOTAL CAR: sum concentration of cariprazine, DCAR and DDCAR; CAR: cariprazine Absorption After single dose administration of VRAYLAR, the peak plasma cariprazine concentration occurred in approximately 3-6 hours. Administration of a single dose of 1.5 mg VRAYLAR capsule with a high-fat meal did not significantly affect the C max and AUC of cariprazine or DCAR. Distribution Cariprazine and its major active metabolites are highly bound (91 to 97%) to plasma proteins.

Elimination Met…

🧬 Mechanism of Action 67 words ▾

12.1Mechanism of Action The mechanism of action of cariprazine is unknown. However, the efficacy of cariprazine could be mediated through a combination of partial agonist activity at central dopamine D 2 and serotonin 5-HT 1A receptors and antagonist activity at serotonin 5-HT 2A receptors. Cariprazine forms two major metabolites, desmethylcariprazine (DCAR) and didesmethylcariprazine (DDCAR), that have in vitro receptor binding profiles similar to the parent drug.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied VRAYLAR (cariprazine) capsules are supplied as follows: Capsule Strength Imprint Codes Capsule Color Package Configuration NDC Code 0.5 mg FL

0.5Ivory to yellow cap and grey to green body Bottle of 30 61874-250-30 0.75 mg FL

0.75Grey to green cap and blue body Bottle of 30 61874-275-30 1.5 mg FL

1.5White cap and body Blister pack of 7 61874-115-17 Bottle of 30 61874-115-30 Bottle of 90 61874-115-90 Box of 20 (Hospital Unit Dose) 61874-115-20 3 mg FL 3 Green to blue-green cap and white body Bottle of 30 61874-130-30 Bottle of 90 61874-130-90 Box of 20 (Hospital Unit Dose) 61874-130-20 4.5 mg FL

4.5Green to blue-green cap and body Bottle of 30 61874-145-30 Bottle of 90 61874-145-90 6 mg FL 6 Purple cap and white body Bottle of 30 61874-160-30 Bottle of 90 61874-160-90 (1) 1.5 mg, (6) 3 mg FL 1.5, FL 3 Mixed Blister pack of 7 61874-170-08

16.2Storage and Handling Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] . Protect 3 mg and 4.5 mg capsules from light to prevent potential color fading.

16.1How Supplied VRAYLAR (cariprazine) capsules are supplied as follows: Capsule Strength Imprint Codes Capsule Color Package Configuration NDC Code 0.5 mg FL

0.5Ivory to yellow cap and grey to green body Bottle of 30 61874-250-30 0.75 mg FL

0.75Grey to green cap and blue body Bottle of 30 61874-275-30 1.5 mg FL

1.5White cap and body Blister pack of 7 61874-115-17 Bottle of 30 61874-115-30 Bottle of 90 61874-115-90 Box of 20 (Hospital Unit Dose) 61874-115-20 3 mg FL 3 Green to blue-green cap and white body Bottle of 30 61874-130-30 Bottle of 90 61874-130-90 Box of 20 (Hospital Unit Dose) 61874-130-20 4.5 mg FL

4.5Green to blue-green cap and body Bottle of 30 61874-145-30 Bottle of 90 61874-145-90 6 mg FL 6 Purple cap and white body Bottle of 30 61874-160-30 Bottle of 90 61874-160-90 (1) 1.5 mg, (6) 3 mg FL 1.5, FL 3 Mixed Blister pack of 7 61874-170-08

📦 Storage and Handling 41 words ▾

16.2Storage and Handling Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] . Protect 3 mg and 4.5 mg capsules from light to prevent potential color fading.

📋 Description 181 words ▾

11 . DESCRIPTION The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans -N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C 21 H 3 2 Cl 2 N 4 O•HCl and its molecular weight is 463.9 g/mol.

The chemical structure is: VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide.

Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg). The chemical structure for VRAYLAR is cariprazine HCl, an atypical antipsychotic. The chemical name is trans-N-{4-[2-[4-(2,3 dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H33Cl3N4O and its molecular weight is 463.9 g/mol.

💬 Information for Patients ~3 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 suicidal thoughts and behaviors, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to their healthcare provider [ see Box Warning and Warnings and Precautions ( 5.2 ) ] . Dosage and Administration Advise patients that VRAYLAR can be taken with or without food.

Counsel them on the 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, family members, or caregivers to contact the healthcare provider or to report to the emergency room if they experience signs and 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 health care provider if these abnormal movements occur [see Warnings and Precautions ( 5.5 )]. Late-Occurring Adverse Reactions Counsel patients that adverse reactions may not appear until several weeks after the initiation of VRAYLAR treatment [see Warnings and Precautions ( 5.6 )]. Metabolic Changes (Hyperglycemia and Diabetes Mellitus, Dyslipidemia, and Weight Gain) 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 [ s ee Warnings and Precautions ( 5.7 )] .

Leukopenia/Neutropenia 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 VRAYLAR [see Warnings and Precautions ( 5.8 )] . Orthostatic Hypotension and Syncope Counsel patients on the risk of orthostatic hypotension and syncope, especially early in treatment, and also at times of re-initiating treatment or increases in dose [see Warnings and Precautions ( 5.9 )] . Interference with Cognitive and Motor Performance Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that VRAYLAR therapy does not affect them adversely [see Warnings and Precautions ( 5.12 )] .

Heat Exposure and Dehydration Educate patients regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions ( 5.13 )] . Concomitant Medication s Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs since there is a potential for interactions [ see Drug Interactions ( 7 ) ] . Pregnancy Advise patients that third trimester use of VRAYLAR may cause extrapyramidal and/or withdrawal symptoms in a neonate.

Advise patients to notify their healthcare provider with a known or suspected pregnancy [ see Use in Specific Populations ( 8.1 )]. Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VRAYLAR during pregnancy [see Use in Specific Populations ( 8.1 )] . Licensed from Gedeon Richter Plc.

Manufactured by: Forest Laboratories Ireland Limited Dublin, IE. Distributed by: AbbVie Inc. North Chicago, IL 60064, USA VRAYLAR and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company. © 2025 AbbVie.

All rights reserved. 20093086

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE VRAYLAR ® (VRAY-lar) (cariprazine) capsules What is the most important information I should know about VRAYLAR? VRAYLAR may cause serious side effects, including : Increased risk of death in elderly people with dementia related psychosis. Medicines like VRAYLAR can raise the risk of death in elderly who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).

VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. Increased risk of suicidal thoughts and actions. VRAYLAR and antidepressant medicines increase the risk of suicidal thoughts or 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. This is very important when VRAYLAR or the antidepressant medicine is started or when the dose is changed. ○ Call the 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 the healthcare provider as scheduled.

Call the 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 has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying suicide attempts new or worse depression new or worse anxiety feeling very agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) See “ What are the possible side effects of VRAYLAR? ” for more information about side effects. other unusual changes in behavior or mood What is VRAYLAR?

VRAYLAR is a prescription medicine used: to treat schizophrenia in adults and children ages 13 years and older to treat short-term (acute) manic or mixed episodes that happen with bipolar I disorder in adults and children ages 10 years and older to treat depressive episodes that happen with bipolar I disorder (bipolar depression) in adults along with antidepressant medicines to treat major depressive disorder (MDD) in adults It is not known if VRAYLAR is safe and effective to treat children: under 13 years of age with schizophrenia under 10 years of age with manic or mixed episodes that happen with bipolar I disorder with bipolar depression along with antidepressant medicines to treat MDD Who should not take VRAYLAR?

Do not take VRAYLAR if you are allergic to cariprazine. See the end of this Medication Guide for a complete list of ingredients in VRAYLAR. Before taking VRAYLAR, tell your healthcare provider about all of your medical conditions, including if you: have or had heart problems or a stroke have or had low or high blood pressure have or had diabetes or high blood sugar, or a family history of diabetes or high blood sugar have or had high levels of total cholesterol, LDL cholesterol, or triglycerides or low levels of HDL cholesterol have or had seizures (convulsions) have or had kidney or liver problems have or had a low white blood cell count are pregnant or plan to become pregnant.

VRAYLAR may harm your unborn baby. Taking VRAYLAR 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 about the risk to your unborn baby if you take VRAYLAR during pregnancy. ○ Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with VRAYLAR. ○ There is a pregnancy exposure registry for women who…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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