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VILAZODONE HYDROCHLORIDE 40 mg Tablet, Film Coated, 90-count

by Alembic Pharmaceuticals Inc. · 90 TABLET, FILM COATED in 1 BOTTLE (62332-234-90)

NDC 62332-0234-90

🏷️ FDA NDC (as labeled) 62332-234-90 billing pads the product segment with a zero

This package

Contains90-count Pack sizes4 compare ↓

Also priced by: Part D plans $2.06/unit — full pricing hub ↓

Also comes in: 30 tablets 62332-0234-30 500 tablets 62332-0234-71 1000 tablets 62332-0234-91

Rx only Generic 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 62332-234-90

Product NDC 62332-234

11-digit billing NDC 62332023490

RxCUI 1086772, 1086778, 1086784

UNII U8HTX2GK8J

UPC 0362332232307, 0362332234301

Application # ANDA208202

SPL Set ID 8b95b850-8bdf-4255-a691-783d1a94bd07

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2022-06-04

Route ORAL

Dosage form TABLET, FILM COATED

Substance VILAZODONE HYDROCHLORIDE

GPI-14 58120088100340

GPI class Vilazodone HCl

GCN Seq No 067378

GCN 29918

HICL code 037597

Ingredient (HICL) Vilazodone 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 H8P

Therapeutic class — specific (HIC3) Ssri And 5Ht1A Partial Agonist Antidepressants

AHFS code 28:16.04.24

AHFS class Serotonin Modulators

FDB label name VILAZODONE HCL 40 MG TABLET

FDB brand name Vilazodone Hcl

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 62332-234-90 — 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 → 62332-0234-90. 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 Other antidepressants class.

Drug family (ATC) Other antidepressants

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

LabelerAlembic Pharmaceuticals Inc.

Application holderALEMBIC PHARMACEUTICALS LTD

FDA applicationANDA208202 (ANDA)

Labeler code62332

First marketedJun 2022

Product typeHuman Prescription Drug

Portfolio491 products on file

🔎 All NDCs from Alembic Pharmaceuticals Inc.

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 VILAZODONE HCL 40 MG TABLET Ingredient Vilazodone Hcl

📖 What it is MedlinePlus · NLM

Vilazodone is used to treat depression. Vilazodone is in a class of medications called serotonin modulators. It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Vilazodone — brand name Viibryd — is an antidepressant approved to treat major depressive disorder (MDD) in adults. MDD is a clinical condition, not just ordinary sadness, and it c...
Yes, this one genuinely matters. If you take vilazodone without food, your body may absorb up to 50% less of the drug — which could make it significantly less effective. Try to tak...
Does it really matter if I take it with food?
The most common ones are digestive: diarrhea, nausea, and sometimes vomiting — especially in the first few weeks. Insomnia, headache, and dizziness are also possible. These often i...

📖 Read our full Vilazodone guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

Vilazodone may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

SODIUM Moderate Depletion

🧪 Full Vilazodone nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

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 Pink / Orange / Blue

ShapeOval

Imprint499;L

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 LMI26O6933
Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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 G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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.

10 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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$2.06	$185.09 / 90 tablets

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Vilazodone Hydrochloride 40 mg 00480-2043-56	Teva	30 tablets	$0.900	AB	Availability likely	—
vilazodone hydrochloride 40 mg 60505-4374-03	Apotex	30 tablets	$0.900	AB	Availability likely	—
Vilazodone hydrochloride 40 mg 69097-0982-02	Cipla	30 tablets	$0.900	AB	Availability likely	—
vilazodone hydrochloride 40 mg 72205-0262-30	Novadoz	30 tablets	$0.900	AB	Availability likely	—
vilazodone hydrochloride 40 mg 72603-0815-01	Northstar	30 tablets	$0.900	AB	Availability likely	—
Vilazodone hydrochloride 40 mg 76282-0546-30	Exelan	30 tablets	$0.900	AB	Availability likely	—
Vilazodone Hydrochloride 40 mg 16729-0354-10	Accord	30 tablets	$1.352	AB	FDA listed	—
Viibryd 40 mg 00456-1140-30	Allergan,	30 tablets	$12.197	AB	Availability likely	—
Vilazodone Hydrochloride 40 mg 46708-0234-30	Alembic	30 tablets	—	AB	FDA listed	—
Vilazodone Hydrochloride 40 mg 51407-0917-30	Golden	30 tablets	—	AB	FDA listed	—
Vilazodone Hydrochloride 40 mgthis 62332-0234-90	Alembic	90 tablets	—	AB	FDA listed	—
vilazodone hydrochloride 40 mg 68788-8735-03	Preferred	30 tablets	—	AB	FDA listed	—
vilazodone hydrochloride 40 mg 82804-0128-30	Proficient	30 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

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

🏛️

2022

On the market since

Jun 2022

📍

2026

Currently FDA-listed

4 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 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 tablets62332-0234-30 15,815 Rx · $723,751

500 tablets62332-0234-71 No Medicaid data

90 tablets this page62332-0234-90 No Medicaid data

1000 tablets62332-0234-91 No Medicaid data

Drug total (last 4 qtrs): 15,815 Rx · 530,938 units · $723,751 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
62332-0234-30	30 TABLET, FILM COATED in 1 BOTTLE (62332-234-30)	$0.8995 / ea	$26.99	2022-06-04	Active
62332-0234-71	500 TABLET, FILM COATED in 1 BOTTLE (62332-234-71)	—	—	2022-06-04	Active
62332-0234-90 You're viewing this	90 TABLET, FILM COATED in 1 BOTTLE (62332-234-90)	—	—	2022-06-04	Active
62332-0234-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-234-91)	—	—	2022-06-04	Active

You're viewing one of 4 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 62332-0234-90?

NDC 62332-0234-90 is a 90-count package — 90 tablet, film coated in 1 bottle.

What is the difference between NDC 62332-0234-90 and NDC 62332-0234-30?

Both are VILAZODONE HYDROCHLORIDE 40 mg Tablet, Film Coated — the drug itself is identical. NDC 62332-0234-90 is the 90-count package, while NDC 62332-0234-30 is the 30 tablets package.

What NDC number is used to bill for this package of VILAZODONE HYDROCHLORIDE 40 mg Tablet, Film Coated?

Bill NDC 62332-0234-90 — the 11-digit billing format is 62332023490. 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.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 62332-234-90, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 62332-0234-90, written without dashes as 62332023490. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 62332-0234-90, the first segment (62332) is the labeler code FDA assigned to Alembic Pharmaceuticals Inc.; the middle segment (0234) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alembic Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 3 other package presentations of this same product, including 30 tablets (62332-0234-30), 500 tablets (62332-0234-71), 1000 tablets (62332-0234-91). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Alembic Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning 121 words ▾

WARNING: 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 emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Vilazodone hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients (5.1). • Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors (5.1). • Vilazodone hydrochloride tablets are not approved for use in pediatric patients (8.4).

🎯 Indications and Usage 39 words ▾

1 INDICATIONS AND USAGE Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults (1)

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • Recommended target dosage: 20 mg to 40 mg once daily with food (2.1, 12.3) • To titrate: start with initial dosage of 10 mg once daily for 7 days, followed by 20 mg once daily. The dose may be increased up to 40 mg once daily after a minimum of 7 days between dosage increases (2.1) • Prior to initiating vilazodone hydrochloride tablets, screen for bipolar disorder (2.2, 5.4) • When discontinuing vilazodone hydrochloride tablets, reduce the dosage gradually (2.4, 5.5)

2.1Dosage for Treatment of Major Depressive Disorder The recommended target dosage for vilazodone hydrochloride tablet is 20 mg to 40 mg orally once daily with food [see Clinical Pharmacology (12.3), Clinical Studies (14)]. To achieve the target dosage, titrate vilazodone hydrochloride tablet as follows: • Start with an initial dosage of 10 mg once daily with food for 7 days, • Then increase to 20 mg once daily with food. • The dose may be increased up to 40 mg once daily with food after a minimum of 7 days between dosage increases.

If a dose is missed, it should be taken as soon as the patient remembers. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regular time. Two doses should not be taken at the same time.

2.2Screen for Bipolar Disorder Prior to Starting Vilazodone Hydrochloride Tablets Prior to initiating treatment with vilazodone hydrochloride tablet or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.4)].

2.3Switching to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of vilazodone hydrochloride tablet. In addition, at least 14 days must elapse after stopping vilazodone hydrochloride tablet before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].

2.4Dosage Adjustments with CYP3A4 Inhibitors or Inducers Patients receiving concomitant CYP3A4 inhibitors : During concomitant use of a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, voriconazole), the vilazodone hydrochloride tablet dose should not exceed 20 mg once daily. The original vilazodone hydrochloride tablet dose level, can be resumed when the CYP3A4 inhibitor is discontinued [see Drug Interactions (7)] . Patients receiving concomitant CYP3A4 inducers : Based on clinical response, consider increasing the dosage of vilazodone hydrochloride tablets by 2-fold, up to a maximum 80 mg once daily, over 1 to 2 weeks in patients taking strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) for greater than 14 days.

If CYP3A4 inducers are discontinued, gradually reduce the vilazodone hydrochloride tablet dosage to its original level over 1 to 2 weeks [see Drug Interactions (7)] .

2.5Discontinuing Treatment with Vilazodone Hydrochloride Tablets Adverse reactions may occur upon discontinuation of vilazodone hydrochloride tablet [see Warnings and Precautions (5.5)] . A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. Vilazodone hydrochloride tablet should be down tapered from the 40 mg once daily dose to 20 mg once daily for 4 days, followed by 10 mg once daily for 3 days.

Patients taking vilazodone hydrochloride tablet 20 mg once daily should be tapered to 10 mg once daily for 7 days.

💊 Dosage Forms and Strengths 87 words ▾

3 DOSAGE FORMS AND STRENGTHS Vilazodone hydrochloride tablets are available as 10 mg, 20 mg and 40 mg, film-coated tablets. 10 mg : Pink, oval, film-coated, biconvex tablets debossed with ‘497’ on one side and plain on other side. 20 mg : Orange, oval, film-coated, biconvex tablets debossed with ‘498’ on one side and ’L’ on other side.

40 mg : Light blue, oval, film-coated, biconvex tablets debossed with ‘499’ on one side and ’L’ on other side. Tablets: 10 mg, 20 mg, and 40 mg (3)

⛔ Contraindications 63 words ▾

4 CONTRAINDICATIONS Vilazodone hydrochloride tablets are contraindicated in: • Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)]. • Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue vilazodone hydrochloride tablets and serotonergic agents and initiate supportive treatment (5.2) • Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.3) • Activation of Mania/Hypomania: Screen patients for bipolar disorder (5.4) • Seizures: Can occur with treatment.

Use with caution in patients with a seizure disorder (5.6) • Angle Closure Glaucoma: Avoid use of antidepressants, including vilazodone hydrochloride tablets, in patients with untreated anatomically narrow angles (5.7) • Sexual Dysfunction: Vilazodone hydrochloride tablets may cause symptoms of sexual dysfunction (5.9)

5.1Suicidal Thoughts and Behavior in 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 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater in antidepressant-treated patients 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 1. Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range (years) Drug-Placebo Difference in Number of Patients with Suicidal Thoughts or Behaviors per 1000 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 and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider.

Consider changing the therapeutic regimen, including possibly discontinuing vilazodone hydrochloride tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2Serotonin Syndrome Serotonin and norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitor (SSRIs), including vilazodone hydrochloride tablets, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, meperidine, methadone, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications (4) and Drug Interactions (7)] .

Serotonin syndrome can also occur when these drugs are used alone. Symptoms of serotonin syndrome were noted in 0.1% of MDD patients treated with vi…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)]. • Serotonin Syndrome [see Warnings and Precautions (5.2)]. • Increased Risk of Bleeding [see Warnings and Precautions (5.3)]. • Activation of Mania or Hypomania [see Warnings and Precautions (5.4)]. • Discontinuation Syndrome [see Warnings and Precautions (5.5)]. • Seizures [see Warnings and Precautions (5.6)]. • Angle-Closure Glaucoma [see Warnings and Precautions (5.7)]. • Hyponatremia [see Warnings and Precautions (5.8)]. • Sexual Dysfunction [see Warnings and Precautions (5.9)].

Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): diarrhea, nausea, vomiting, and insomnia (6) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 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 and varying lengths of time, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice. The most commonly observed adverse reactions in vilazodone hydrochloride tablets-treated with major depressive disorder (MDD) in placebo-controlled studies (incidence ≥ 5% and at least twice the rate of placebo) were diarrhea, nausea, vomiting, and insomnia.

Patient Exposure The safety of vilazodone hydrochloride tablets were evaluated in 3,007 patients (18 to 70 years of age) diagnosed with MDD who participated in clinical studies, representing 676 patient-years of exposure. In an open-label 52 week study at 40 mg daily, 599 patients were exposed to vilazodone hydrochloride tablets for a total of 348 patient-years. The adverse reaction information presented below was derived from studies of vilazodone hydrochloride tablets 20 mg and 40 mg daily in patients with MDD including: • Four placebo-controlled 8 to 10-week studies in 2,233 patients, including 1,266 vilazodone hydrochloride tablets -treated patients; and • An open-label 52-week study of 599 vilazodone hydrochloride tablets -treated patients.

These studies included a titration period of 10 mg daily for 7 days, followed by 20 mg daily for 7 days or to 40 mg daily over 2 weeks. In these clinical trials, vilazodone hydrochloride tablets were administered with food. Adverse reactions reported as reasons for discontinuation of treatment In these studies, 7.3% of the vilazodone hydrochloride tablets-treated patients discontinued treatment due to an adverse reaction, compared with 3.5% of placebo-treated patients.

The most common adverse reaction leading to discontinuation in at least 1% of the vilazodone hydrochloride tablets-treated patients in the placebo-controlled studies was nausea (1.4%). Common adverse reactions in placebo-controlled MDD studies Table 2 shows the incidence of common adverse reactions occurring in ≥ 2% of vilazodone hydrochloride tablets-treated patients and greater than the rate of placebo-treated patients in MDD Studies. There were no dose-related adverse reactions between 20 mg and 40 mg reported.

Table 2: Common Adverse Reactions Occurring in ≥2% of Vilazodone Hydrochloride Tablets-Treated Patients and Greater than the Rate of Placebo-Treated Patients System Organ Class Preferred Term Placebo N=967 Vilazodone Hydrochloride Tablets 20 mg/day N=288 Vilazodone Hydrochloride Tablets 40 mg/day N=978 Gastrointestinal disorders Diarrhea 10% 26% 29% Nausea 7% 22% 24% Dry mouth 5% 8% 7% Vomiting 2% 4% 5% Abdominal pain 1 3% 7% 4% Dyspepsia 2% 2% 3% Flatulence 1% 3% 3% Gastroenteritis 1% 1% 2% Abdominal distension 1% 2% 1% Nervous system disorders Headache 2 14% 15% 14% Dizziness 5% 6% 8% Somnolence 2% 4% 5% Paresthesia 1% 1% 2% Psychiatric disorders Insomnia 2% 7% 6% Abnor…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • CYP3A4 Inhibitors: The vilazodone hydrochloride tablet dose should not exceed 20 mg once daily when co-administered with strong CYP3A4 inhibitors (2.4, 7) • CYP3A4 Inducers: Consider increasing vilazodone hydrochloride tablets dosage by 2-fold, up to 80 mg once-daily over 1 to 2 weeks when used concomitantly with strong CYP3A4 inducers for greater than 14 days (2.4, 7)

7.1Drugs Having Clinically Important Interactions With Vilazodone Hydrochloride Tablets Table 4: Clinically Important Drug Interactions with Vilazodone Hydrochloride Tablets Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation Monoamine Oxidase Inhibitors (MAOIs) The concomitant use of MAOIs and serotonergic drugs including vilazodone hydrochloride tablets increases the risk of serotonin syndrome. Vilazodone hydrochloride tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Contraindications (4), Dosage and Administration (2.3), and Warnings and Precautions (5.2)].

Other Serotonergic Drugs Concomitant use of vilazodone hydrochloride tablets with other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) increases the risk of serotonin syndrome. Monitor patients for signs and symptoms of serotonin syndrome, particularly during vilazodone hydrochloride tablets initiation.

If serotonin syndrome occurs, consider discontinuation of vilazodone hydrochloride tablets and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2)]. Antiplatelet Agents and Anticoagulants Serotonin release by platelets plays an important role in hemostasis. The concurrent use of an antiplatelet agent or anticoagulant with vilazodone hydrochloride tablets may potentiate the risk of bleeding.

Inform patients of the increased risk of bleeding with the concomitant use of vilazodone hydrochloride tablets and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating, titrating, or discontinuing vilazodone hydrochloride tablets [see Warnings and Precautions (5.3)]. Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin, voriconazole) The concomitant use of vilazodone hydrochloride tablets and strong CYP3A4 inhibitors increased the exposure of vilazodone compared to the use of vilazodone hydrochloride tablets alone [see Clinical Pharmacology (12.3)].

The vilazodone hydrochloride tablet dose should not exceed 20 mg once daily with the concomitant use of a strong CYP3A4 inhibitor [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)]. Strong CYP3A4 Inducers (e.g., carbamazepine, phenytoin, rifampin) The concomitant use of vilazodone hydrochloride tablets and strong CYP3A4 inducers decreased the exposure of vilazodone compared to the use of vilazodone hydrochloride tablets alone [see Clinical Pharmacology (12.3)]. Based on clinical response, consider increasing the dosage of vilazodone hydrochloride tablets, over 1 to 2 weeks in patients taking strong CYP3A4 inducers for greater than 14 days [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)].

Digoxin Digoxin is a narrow therapeutic index drug. Concomitant use of vilazodone hydrochloride tablets increased digoxin concentrations [see Clinical Pharmacology (12.3)] . Measure serum digoxin concentrations before initiating concomitant use of vilazodone hydrochloride tablets.

Continue monitoring and reduce digoxin dose as necessary.

7.2Drugs Having No Clinically Important Interactions With Vilazodone Hydrochloride Tablets Based on pharmacokinetic studies, no dosage adjustment is required for drugs that are substrates of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4, and/or P-glycoprotein (except narrow therapeutic index drugs, e.g., digoxin), when vilazodone hydrochloride tablets are administered c…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the newborn (8.1)

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.3) and Clinical Considerations] .

There are no adequate and well-controlled studies of vilazodone hydrochloride tablets in pregnant women. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

In animal reproduction studies, oral administration of vilazodone during the period of organogenesis at doses up to 48 and 17 times the maximum recommended human dose (MRHD) in rats and rabbits, respectively, resulted in decreased fetal body weight gain and delayed skeletal ossification but no teratogenic effects were observed. Decreased fetal body weight and delayed skeletal ossification were not observed at doses up to 10 and 4 times the MRHD in rats and rabbits, respectively [see Data] . Clinical Considerations Disease-associated maternal and/or embryo/fetal risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.

The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of vilazodone hydrochloride tablets in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.3)] .

Fetal/Neonatal adverse reactions Exposure to SSRIs and SNRIs, including vilazodone hydrochloride tablets, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). Monitor neonates who were exposed to vilazodone hydrochloride tablets in the third trimester of pregnancy for PPHN and drug discontinuation syndrome [see Data] . Data Human Data Third Trimester Exposure Neonates exposed to SSRIs or SNRIs late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

These findings are based on post-marketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.

These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome [see Warnings and Precautions (5.2)] . Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN).

PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associate…

🤰 Pregnancy ~3 min read ▾

PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women who…

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of vilazodone hydrochloride tablets have not been established in pediatric patients for the treatment of MDD. Efficacy was not demonstrated in two adequate and well controlled, 8-week studies including a total of 1002 pediatric patients ages 7 years to 17 years of age with MDD. The following adverse reactions were reported in at least 5% of pediatric patients treated with vilazodone hydrochloride tablets and occurred at a rate at least twice that for pediatric patients receiving placebo: nausea, vomiting, diarrhea, abdominal pain/discomfort, and dizziness.

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions (5.1), and Adverse Reactions (6.2)] . Juvenile Animal Toxicity Data In a juvenile animal study, male and female rats were treated with vilazodone (10, 50, and 200 mg/kg/day) starting on postnatal day (PND) 21 through 90. A delay in the age of attainment of vaginal patency (i.e., sexual maturation) was observed in females starting at 50 mg/kg/day with a No Observed Adverse Effect Level (NOAEL) of 10 mg/kg/day.

This NOAEL was associated with AUC levels similar to those measured at a maximum dose tested in pediatrics (30 mg). Adverse behavioral effects (lack of habituation in an acoustic startle test) were observed in males at 200 mg/kg and females starting at 50 mg/kg both during drug treatment and the recovery periods. The NOAEL for this finding was 50 mg/kg for males and 10 mg/kg for females, which was associated with AUC levels greater than (males) or similar (females), to those observed with the maximum dose tested in pediatric patients.

An 8% decrease in femur mineral density was observed in female rats at 200 mg/kg, compared to the control group. The NOAEL for this finding was 50 mg/kg, which was associated with an AUC level greater than those measured at the maximum dose tested in pediatrics.

🧓 Geriatric Use 206 words ▾

8.5Geriatric Use Based on a pharmacokinetic study, no dosage adjustment of vilazodone hydrochloride tablets are recommended on the basis of age (see Figure 3). Results from pharmacokinetic study of a single 20 mg vilazodone hydrochloride tablet dose in geriatric subjects (> 65 years-old) vs. younger subjects (24 to 55 years-old) demonstrated that the pharmacokinetics were generally similar between the two age groups [see Clinical Pharmacology (12.3)]. Clinical studies of vilazodone hydrochloride tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Of the 3,007 patients in clinical studies with vilazodone hydrochloride tablets, 65 (2.2%) were 65 years of age or older, and 378 (12.6%) were 55 to 64 years of age. In general, dose selection for an elderly patient should be conservative, 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. Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.8)] .

No other differences in adverse reactions were observed between geriatric and younger patients.

🆘 Overdosage 105 words ▾

10 OVERDOSAGE There is limited clinical trial experience regarding human overdose with vilazodone hydrochloride tablets. The adverse reactions associated with overdose of vilazodone hydrochloride tablets at doses of 200 to 280 mg (5 to 7 times the recommended dosage) as observed in clinical trials included serotonin syndrome, lethargy, restlessness, hallucinations, and disorientation. For current information on the management of poisoning or overdose, contact a poison control center at 1-800-222-1222.

No specific antidotes for vilazodone are known. Removal of vilazodone by dialysis has not been studied; however, the high volume of distribution of vilazodone suggests that dialysis will not be effective in reducing vilazodone plasma concentrations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of vilazodone in the treatment of major depressive disorder is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT 1A receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown.

12.2Pharmacodynamics Vilazodone binds with high affinity to the serotonin reuptake site (Ki= 0.1 nM), but not to the norepinephrine (Ki=56 nM) or dopamine (Ki=37 nM) reuptake sites. Vilazodone potently and selectively inhibits reuptake of serotonin (IC 50 = 1.6 nM). Vilazodone also binds selectively with high affinity to 5-HT 1A receptors (IC 50 =2.1 nM) and is a 5-HT 1A receptor partial agonist.

Cardiac Electrophysiology Treatment with vilazodone hydrochloride tablets did not prolong the QTc interval. The effect of vilazodone hydrochloride tablets [20, 40, 60, and 80 mg (2 times the recommended dosage)] on the QTc interval was evaluated in a randomized, placebo-, and active-controlled (moxifloxacin 400 mg), parallel-group, thorough QTc study in 157 healthy subjects. The study demonstrated an ability to detect small effects.

The upper bound of the 90% confidence interval for the largest placebo-adjusted, baseline-corrected QTc interval was below 10 msec, based on the individual correction method (QTcI). Thus, at doses of 2 times the recommended dosage, vilazodone hydrochloride tablets did not prolong the QTc interval to a clinically relevant extent.

12.3Pharmacokinetics Vilazodone activity is due primarily to the parent drug. The pharmacokinetics of vilazodone (5 mg to 80 mg) are dose-proportional. Accumulation of vilazodone after administration of single vilazodone hydrochloride tablet doses did not vary with dose, and steady-state was achieved in about 3 days.

Elimination of vilazodone is primarily by hepatic metabolism with a terminal half-life of approximately 25 hours. At steady-state, after daily dosing of vilazodone hydrochloride tablets 40 mg under fed conditions, the mean C max value is 156 ng/mL, and the mean AUC ( 0-24 hours ) value is 1645 ng·h/mL. Absorption Vilazodone concentrations peaked at a median of 4 to 5 hours (T max ) after vilazodone hydrochloride tablets administration and decline with a terminal half-life of approximately 25 hours.

The absolute bioavailability of vilazodone is 72% with food. Vilazodone AUC and C max in the fasted state can be decreased by approximately 50% and 60%, respectively, compared to the fed state. Administration without food can result in inadequate drug concentrations and may reduce effectiveness.

Coadministration of vilazodone hydrochloride tablets with ethanol or with a proton pump inhibitor (pantoprazole) did not affect the rate or extent of vilazodone absorption. In addition, neither the Tmax nor terminal elimination rate of vilazodone was altered by coadministration with either pantoprazole or ethanol. Absorption is decreased by approximately 25% if vomiting occurs within 7 hours of ingestion; no replacement dose is needed.

Distribution Vilazodone is widely distributed and approximately 96 to 99% protein-bound. Administration of vilazodone hydrochloride tablets to a patient taking another drug that is highly protein bound may cause increased free concentrations of the other drug, because vilazodone is highly bound to plasma protein. The interaction between vilazodone and other highly protein-bound drugs has not been evaluated.

Metabolism and Elimination Vilazodone hydrochloride tablet is extensively metabolized through CYP and non-CYP pathways (possibly by carboxylesterase), with only 1% of the dose recovered in the urine and 2% of the dose recovered in the feces as unchanged vilazodone. CYP3A4 is primarily responsible for its metabolism among CYP pathways, with minor contribution…

🧬 Mechanism of Action 72 words ▾

📦 How Supplied / Storage and Handling 155 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Vilazodone hydrochloride tablets 10 mg are pink, oval, film-coated, biconvex tablets debossed with ‘497’ on one side and plain on other side. Bottle of 30 NDC 62332-232-30 Bottle of 90 NDC 62332-232-90 Bottle of 500 NDC 62332-232-71 Bottle of 1000 NDC 62332-232-91 Vilazodone hydrochloride tablets 20 mg are orange, oval, film-coated, biconvex tablets debossed with ‘498’ on one side and ‘L’ on other side. Bottle of 30 NDC 62332-233-30 Bottle of 90 NDC 62332-233-90 Bottle of 500 NDC 62332-233-71 Bottle of 1000 NDC 62332-233-91 Vilazodone hydrochloride tablets 40 mg are light blue, oval, film-coated, biconvex tablets debossed with ‘499’ on one side and ‘L’ on other side.

Bottle of 30 NDC 62332-234-30 Bottle of 90 NDC 62332-234-90 Bottle of 500 NDC 62332-234-71 Bottle of 1000 NDC 62332-234-91 Vilazodone hydrochloride tablets should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 128 words ▾

11 DESCRIPTION Vilazodone hydrochloride tablets for oral administration contain vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT 1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1 H -indol-3-yl)butyl]-1-piperazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99.

The structural formula is: Vilazodone hydrochloride tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, vilazodone hydrochloride tablets contain microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, FD&C Red No. # 40 Al Lake (10 mg only), FD&C Yellow No. # 6 Al Lake (20 mg only) and FD&C Blue No. # 1 Al Lake (40 mg only). vilazodone-fig.jpg

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient 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 and Warnings and Precautions (5.1)] . Dosage and Administration Instruct patients to take vilazodone hydrochloride tablets with food and to follow prescribed dosage instructions [see Dosage and Administration (2.1, 2.3, 2.4, 2.5)].

Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of vilazodone hydrochloride tablets with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7)] .

Increased Risk of Bleeding Inform patients about the concomitant use of vilazodone hydrochloride tablets with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake (e.g., vilazodone hydrochloride tablets) and these medications has been associated with an increased risk of bleeding. Advise them to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.3)] .

Activation of Mania/Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.4)] . Discontinuation Syndrome Advise patients not to abruptly discontinue vilazodone hydrochloride tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when vilazodone hydrochloride tablets are discontinued [see Warnings and Precautions (5.5)].

Seizures Caution patients about using vilazodone hydrochloride tablets if they have a history of a seizure disorder [see Warnings and Precautions (5.6)] . Sexual Dysfunction Advise patients that use of vilazodone hydrochloride tablets may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.9)] .

Allergic Reactions Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions (6.2)] . Concomitant Medications Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions (7.1)]. Pregnancy • Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with vilazodone hydrochloride tablets [see Use in Specific Populations (8.1)]. • Advise patients that vilazodone hydrochloride tablets use late in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations (8.1)] . • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to vilazodone hydrochloride tablets du…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Vilazodone ( vil-AZ-oh-done ) Hydrochloride Tablets, for oral use What is the most important information I should know about vilazodone hydrochloride tablets? Vilazodone hydrochloride tablets may cause serious side effects, including: • Increased risk of suicidal thoughts or actions in some children, adolescents, and young adults. Vilazodone hydrochloride tablets and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.

Vilazodone hydrochloride tablet is not for use in children. o Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness) or have a history of suicidal thoughts or actions.

How can I watch for and try to prevent suicidal thoughts and actions? o Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. o Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. o 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 your healthcare provider or get emergency medical help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you: • attempts to commit suicide • acting on dangerous impulses • acting aggressive, being angry or violent • thoughts about suicide or dying • new or worse depression • new or worse anxiety • panic attacks • feeling agitated or restless • new or worse irritability • trouble sleeping (insomnia) • an extreme increase in activity • other unusual changes in behavior or or talking (mania) mood What is vilazodone hydrochloride tablet?

Vilazodone hydrochloride tablet is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults. It is not known if vilazodone hydrochloride tablet is safe and effective for use in children for the treatment of MDD. Who should not take vilazodone hydrochloride tablets?

Do not take vilazodone hydrochloride tablets if you: • take a Monoamine Oxidase Inhibitor (MAOI) • have stopped taking an MAOI in the last 14 days • are being treated with the antibiotic linezolid or intravenous methylene blue Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue. Do not start taking an MAOI for at least 14 days after you stop treatment with vilazodone hydrochloride tablets. Before taking vilazodone hydrochloride tablets, tell your healthcare provider about all your medical conditions, including if you: • have or have a family history of suicide, depression, bipolar disorder, mania or hypomania • have or had bleeding problems • have or had seizures or convulsions • have high pressure in the eye (glaucoma) • have or had seizures or convulsions • have low sodium levels in your blood • drink alcohol • are pregnant or plan to become pregnant.

Taking Vilazodone hydrochloride tablets late in pregnancy may lead to an increased risk of certain problems in your newborn. Talk to your healthcare provider about the risks to your baby if you take vilazodone hydrochloride tablets during pregnancy. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with vilazodone hydrochloride tablets. o There is a pregnancy registry for females who are exposed to vilazodone hydr…

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

antiplatelet: A medicine that makes platelets, the blood cells that start a clot, less likely to clump together.

contraindicated: Should not be used in that situation, because the risk is considered too high.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

abdominal distension: A swollen or stretched feeling in the belly, often from gas or fluid.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

Active ingredient: The part of a medicine that produces its intended effect on the body.

active-controlled: Describes a study that compares a new medicine against another medicine already known to work, instead of a dummy pill.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

apnea: A pause or temporary stop in breathing.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

cyanosis: A bluish color of the skin, lips, or nails caused by too little oxygen in the blood.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

CYP2C9: A liver enzyme that breaks down certain medicines, including some blood thinners and anti-inflammatory drugs.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic metabolism: The breakdown of a medicine by the liver into other substances the body can use or remove.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperreflexia: Overactive or exaggerated reflexes, such as an unusually strong knee-jerk response.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypomania: A milder form of mania, with raised energy and mood that is less severe and shorter-lasting than a full manic episode.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

narrow therapeutic index: Describes a medicine where the helpful dose and the harmful dose are very close, so small changes in the amount matter a lot.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

P-glycoprotein: A tiny pump in cells that pushes certain medicines back out, affecting how much of a medicine is absorbed or stays in the body.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

partial agonist: A substance that switches on a body target only part way, giving a weaker effect than a full activator would.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

postpartum: The period of time right after a woman gives birth.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pulmonary hypertension: High blood pressure in the arteries that carry blood from the heart to the lungs.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

relapse: The return of a cancer after a period of improvement or disappearance.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

suicidality: A general term covering both thoughts about ending one's own life and actions taken toward it.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

terminal half-life: The time it takes blood levels to fall by half during the final, slowest stage of removal.

therapeutic index: A measure of how much room there is between a helpful dose of a medicine and a dose that could be harmful.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

Tmax: The time after a dose when a medicine reaches its highest level in the blood.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

← 62332-0233-30 · Alembic 62332-0235-04 · Alembic →

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.

VILAZODONE HYDROCHLORIDE 40 mg Tablet, Film Coated, 90-count

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