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Venlafaxine Hydrochloride 75 mg Capsule, Extended Release, 30-count — NDC 42291-0898-30 package photo

Venlafaxine Hydrochloride 75 mg Capsule, Extended Release, 30-count

by AvKARE · 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-898-30)
NDC 42291-0898-30
🏷️ FDA NDC (as labeled) 42291-898-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2146/unit — full pricing hub ↓
Also comes in: 90 capsules 42291-0898-90 500 capsules 42291-0898-50
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

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

🆔 Identity & classification

FDA NDC (as labeled) 42291-898-30
Product NDC 42291-898
11-digit billing NDC 42291089830
NCPDP billing unit EA — each (per item)
RxCUI 313581, 313583, 313585
UNII 7D7RX5A8MO
Application # ANDA076565
SPL Set ID 7f224c88-9425-9ef0-01bc-dcf3bdafbd89
Established class (EPC) Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of action Norepinephrine Uptake Inhibitors; Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-07-10
Route ORAL
Dosage form CAPSULE, EXTENDED RELEASE
Substance VENLAFAXINE HYDROCHLORIDE
GPI-14 58180090107030
GPI class Venlafaxine HCl ER
GCN Seq No 046404
GCN 16817
HICL code 008847
Ingredient (HICL) Venlafaxine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7C
Therapeutic class — specific (HIC3) Serotonin-Norepinephrine Reuptake-Inhib (Snris)
AHFS code 28:16.04.16
AHFS class Sel.serotonin,Norepi Reuptake Inhibitor
FDB label name VENLAFAXINE HCL ER 75 MG CAP
FDB brand name Venlafaxine Hcl Er
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 42291-898-30 — 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 → 42291-0898-30. 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 Serotonin and Norepinephrine Reuptake Inhibitor class.

Pharmacologic class Serotonin and Norepinephrine Reuptake Inhibitor
Drug family (ATC) Other antidepressants
How it works Norepinephrine Uptake Inhibitors, Serotonin Uptake Inhibitors
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

LabelerAvKARE
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA076565 (ANDA)
Labeler code42291
First marketedJul 2013
Product typeHuman Prescription Drug
Portfolio380 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 VENLAFAXINE HCL ER 75 MG CAP Ingredient Venlafaxine Hcl
📗 Our plain-language guide HelloPharmacist
  • Venlafaxine treats major depressive disorder in all its forms. Depending on which formulation you're prescribed, it can also treat generalized anxiety disorder, social anxiety diso...
  • Most people don't feel a full benefit right away — it typically takes several weeks before you notice a meaningful improvement in mood or anxiety. Blood levels stabilize within abo...
  • How long does it take for venlafaxine to start working?
  • The most common side effects are nausea, dry mouth, sweating, drowsiness or insomnia, dizziness, and decreased appetite — and many of these tend to improve after the first couple o...
📖 Read our full Venlafaxine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

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

🧪 Full Venlafaxine 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 brown / gray / orange
ShapeCapsule
Imprint93;7386;93;7386
Size23 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 4W5IH7FLNY
    A clear, oily liquid derived from sebacic acid and butanol. It works as a plasticizer and solvent in pharmaceutical coatings and films, helping them stay flexible and smooth.
  • UNII H3UP11403C
    Ethylcellulose is a plant-derived polymer that thickens and forms protective coatings on tablets and capsules. It slows medicine release into the body and protects the contents from moisture and air.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

15 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 eachPer 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 $0.2146 $6.44 / 30 capsules
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
Venlafaxine Hydrochloride 75 mg 00093-7385-05 Teva 500 capsules $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 00904-7488-61 Major 1 capsule $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 42806-0602-09 Epic 90 capsules $0.079 AB Availability likely —
venlafaxine hydrochloride 75 mg 43598-0001-10 Dr.Reddys 1000 capsules $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 50268-0874-15 AvPAK 1 capsule $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 62332-0793-30 Alembic 30 capsules $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 65862-0528-01 Aurobindo 100 capsules $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 68084-0709-01 American 1 capsule $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 70010-0185-03 Granules 30 capsules $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 70710-1699-00 Zydus 1000 capsules $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 82009-0057-10 QUALLENT 1000 capsules $0.079 AB Availability likely —
Venlafaxine hydrochloride 75 mg 33342-0195-07 Macleods 30 capsules $0.100 AB FDA listed —
Effexor XR 75 mg 58151-0126-77 Viatris 90 capsules $19.836 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 00615-8509-39 NCS 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 10135-0826-10 Marlex 1000 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 31722-0003-01 Camber 10 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mgthis 42291-0898-30 AvKARE 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 42708-0054-30 QPharma, 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 42708-0194-30 QPharma, 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 46708-0793-30 Alembic 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-2180-00 A-S 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-6214-00 A-S 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-6517-00 A-S 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-6599-00 A-S 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-7317-00 A-S 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-7319-00 A-S 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-7941-00 A-S 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 51655-0849-26 Northwind 90 capsules — AB FDA listed —
venlafaxine hydrochloride 75 mg 55111-0454-01 Dr.Reddy's 100 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 55154-0197-00 Cardinal 1 capsule — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 63187-0177-30 Proficient 30 capsules — AB FDA listed —
venlafaxine hydrochloride 75 mg 65841-0752-06 Zydus 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 67046-0390-03 Coupler 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68071-3653-09 NuCare 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68071-3886-03 NuCare 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68071-4897-03 NuCare 30 capsules — AB FDA listed —
venlafaxine hydrochloride 75 mg 68382-0035-06 Zydus 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68788-8068-03 Preferred 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68788-8140-03 Preferred 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68788-8694-03 Preferred 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68788-8837-03 Preferred 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 70518-2107-00 REMEDYREPACK 30 capsules — AB Discontinued —
Venlafaxine Hydrochloride 75 mg 70518-4151-00 REMEDYREPACK 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 70518-4280-00 REMEDYREPACK 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 70518-4632-00 REMEDYREPACK 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 70771-1837-00 Zydus 1000 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 71205-0369-30 Proficient 30 capsules — AB FDA listed —
venlafaxine hydrochloride 75 mg 71335-1338-01 Bryant 90 capsules — AB Discontinued —
Venlafaxine Hydrochloride 75 mg 71335-1868-01 Bryant 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 71335-1993-01 Bryant 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 71335-2421-01 Bryant 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 71335-2971-01 Bryant 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 71785-1007-00 Annora 30 capsules — AB FDA listed —
Venlafaxine HCL ER 75 mg 72189-0414-60 Direct_Rx 60 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 72603-0748-01 NorthStar 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 72888-0180-30 Advagen 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 76420-0631-01 Asclemed 100 capsules — AB FDA listed —
Venlafaxine hydrochloride ER 75 mg 80425-0296-01 Advanced 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 80425-0396-01 Advanced 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 80425-0470-01 Advanced 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 80425-0471-01 Advanced 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 80425-0472-01 Advanced 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 24658-0126-10 PURACAP 1000 capsules — 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

🏛️
2013
On the market since
Jul 2013
📍
2026
Currently FDA-listed
13 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for VENLAFAXINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Nausea9,124
Fatigue8,208
Headache7,507
Dizziness6,594
Depression6,359
Anxiety6,176
Pain5,572

Age at onset

Neonate605
Infant45
Child25
Adolescent200
Adult10,846
Elderly4,452

Reporter sex

0 reports

Serious outcomes

Hospitalization41,900
Death13,165
Life-threatening7,253
Disabling4,781
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 9,286 3,377
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
42291-0898-30 You're viewing this 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-898-30) 2021-06-21 Active
42291-0898-50 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-898-50) 2021-06-21 Active
42291-0898-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-898-90) 2013-07-10 Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 42291-0898-30?
NDC 42291-0898-30 is a 30-count package — 30 capsule, extended release in 1 bottle.
What is the difference between NDC 42291-0898-30 and NDC 42291-0898-90?
Both are Venlafaxine Hydrochloride 75 mg Capsule, Extended Release — the drug itself is identical. NDC 42291-0898-30 is the 30-count package, while NDC 42291-0898-90 is the 90 capsules package.
What NDC number is used to bill for this package of Venlafaxine Hydrochloride 75 mg Capsule, Extended Release?
Bill NDC 42291-0898-30 — the 11-digit billing format is 42291089830. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 42291-898-30, 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: 42291-0898-30, written without dashes as 42291089830. 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 42291-0898-30, the first segment (42291) is the labeler code FDA assigned to AvKARE; the middle segment (0898) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 AvKARE. 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 2 other package presentations of this same product, including 90 capsules (42291-0898-90), 500 capsules (42291-0898-50). 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?
AvKARE 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 ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide
🚨 Boxed Warning 162 words ▾

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)]. In patients of all ages who are started on antidepressant therapy monitor closely for clinical worsening and emergence of suicidal thoughts and behaviors.

Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) and Patient Counseling Information (17)]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants (5.1) Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1) Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients (8.4)

🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE

1.1Major Depressive Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.

1.2Generalized Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials.

1.3Social Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26- week, placebo-controlled trials.

1.4Panic Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials. Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: (1) (1) • Major Depressive Disorder (MDD) • Generalized Anxiety Disorder (GAD) • Social Anxiety Disorder (SAD) • Panic Disorder (PD)

1.1Major Depressive Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.

1.2Generalized Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials.

1.3Social Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26- week, placebo-controlled trials.

1.4Panic Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.

1.1Major Depressive Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.

1.2Generalized Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials.

1.3Social Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26- week, placebo-controlled trials.

1.4Panic Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Venlafaxine hydrochloride extended-release capsules should be administered in a single dose with food, either in the morning or in the evening at approximately the same time each day [see Clinical Pharmacology (12.3)]. Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. This drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets (spheroids).

Indication Starting Dose Target Dose Maximum Dose MDD (2.1) 37.5 to 75 mg/day 75 mg/day 225 mg/day GAD (2.2) 37.5 to 75 mg/day 75 mg/day 225 mg/day SAD (2.3) 75 mg/day 75 mg/day 75 mg/day PD (2.4) 37.5 mg/day 75 mg/day 225 mg/day • Take once daily with food (2). Capsules should be taken whole; do not divide, crush, chew, or dissolve (2). • When discontinuing treatment, reduce the dose gradually (2.8, 5.7). • Renal impairment: reduce the total daily dose by 25% to 50% in patients with renal impairment. Reduce the total daily dose by 50% or more in patients undergoing dialysis or with severe renal impairment (2.6). • Hepatic impairment: reduce the daily dose by 50% in patients with mild to moderate hepatic impairment.

In patients with severe hepatic impairment or hepatic cirrhosis, it may be necessary to reduce the dose by more than 50% (2.6).

2.1Major Depressive Disorder For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules is 75 mg per day, administered in a single dose. For some patients, it may be desirable to start at 37.5 mg per day for 4 to 7 days to allow new patients to adjust to the medication before increasing to 75 mg per day. Patients not responding to the initial 75 mg per day dose may benefit from dose increases to a maximum of 225 mg per day.

Dose increases should be in increments of up to 75 mg per day, as needed, and should be made at intervals of not less than 4 days, since steady-state plasma levels of venlafaxine and its major metabolites are achieved in most patients by day 4 [see Clinical Pharmacology (12.3)]. In the clinical studies establishing efficacy, upward titration was permitted at intervals of 2 weeks or more. It should be noted that, while the maximum recommended dose for moderately depressed outpatients is also 225 mg per day for venlafaxine tablets (immediate-release), more severely depressed inpatients in one study of the development program for that product responded to a mean dose of 350 mg per day (range of 150 to 375 mg per day).

Whether or not higher doses of venlafaxine hydrochloride extended- release capsules are needed for more severely depressed patients is unknown; however, the experience with venlafaxine hydrochloride extended-release capsules doses higher than 225 mg per day is very limited.

2.2Generalized Anxiety Disorder For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules is 75 mg per day, administered in a single dose. For some patients, it may be desirable to start at 37.5 mg per day for 4 to 7 days to allow new patients to adjust to the medication before increasing to 75 mg per day. Patients not responding to the initial 75 mg per day dose may benefit from dose increases to a maximum of 225 mg per day.

Dose increases should be in increments of up to 75 mg per day, as needed, and should be made at intervals of not less than 4 days, since steady-state plasma levels of venlafaxine and its major metabolites are achieved in most patients by day 4 [see Clinical Pharmacology (12.3)].

2.3Social Anxiety Disorder (Social Phobia) The recommended dose is 75 mg per day, administered in a single dose. There was no evidence that higher doses confer any additional benefit.

2.4Panic Disorder The recommended starting dose is 37.5 mg per day of venlafaxine hydrochlor…

💊 Dosage Forms and Strengths 102 words ▾

Venlafaxine hydrochloride extended-release capsules are available in the following strengths: • 37.5 mg capsules - light-gray opaque cap/buff opaque body with “93” and “7384” on both body and cap. • 75 mg capsules - buff opaque cap/buff opaque body with “93” and “7385” on both body and cap. • 150 mg capsules - light-orange opaque cap/light-orange opaque body with “93” and “7386” on both body and cap. • Venlafaxine hydrochloride extended-release capsules are available as 37.5 mg, 75 mg and 150 mg strengths (3). • Each capsule contains venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg or 150 mg of venlafaxine (3).

⛔ Contraindications ~2 min read ▾

CONTRAINDICATIONS

4.1Hypersensitivity Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation

4.2Concomitant Use with Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an MAOI (intended to treat psychiatric disorders) is also contraindicated [see Dosage and Administration (2.9), Warnings and Precautions (5.2), and Drug Interactions (7.2)].

Starting venlafaxine hydrochloride extended-release capsules in a patient who is being treated with an MAOI such as linezolid or intravenous methylene blue is also contraindicated, because of an increased risk of serotonin syndrome [see Dosage and Administration (2.9), Warnings and Precautions (5.2), and Drug Interactions (7.3)]. • Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the venlafaxine hydrochloride extended-release capsules formulation (4.1). • Do not use with an MAOI or within 14 days of stopping an MAOI.

Allow 7 days after stopping venlafaxine hydrochloride extended-release capsules before starting an MAOI, because of the risk of serotonin syndrome (4.2, 5.2, 7.3).

4.1Hypersensitivity Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation

4.2Concomitant Use with Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an MAOI (intended to treat psychiatric disorders) is also contraindicated [see Dosage and Administration (2.9), Warnings and Precautions (5.2), and Drug Interactions (7.2)].

Starting venlafaxine hydrochloride extended-release capsules in a patient who is being treated with an MAOI such as linezolid or intravenous methylene blue is also contraindicated, because of an increased risk of serotonin syndrome [see Dosage and Administration (2.9), Warnings and Precautions (5.2), and Drug Interactions (7.3)].

4.1Hypersensitivity Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation

4.2Concomitant Use with Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an MAOI (intended to treat psychiatric disorders) is also contraindicated [see Dosage and Administration (2.9), Warnings and Precautions (5.2), and Drug Interactions (7.2)].

Starting venlafaxine hydrochloride extended-release capsules in a patient who is being treated with an MAOI such as linezolid or intravenous methylene blue is also contraindicated, because of an increased risk of serotonin syndrome [see Dosage and Administration (2.9), Warnings and Precautions (5.2), and Drug Interactions (7.3)].

⚠️ Warnings and Cautions ~3 min read ▾

5.1Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled studies of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with MDD and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled studies in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 24 short-term studies of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled studies in adults with MDD or other psychiatric disorders included a total of 295 short-term studies (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied.

There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug versus placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1.

No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer term use, i.e., beyond several months.

However, there is substantial evidence from placebo-controlled maintenance studies in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for MDD, as well as for other indications, both psychiatric and nonpsychiatric.

Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, espec…

⚠️ Warnings ~3 min read ▾

WARNINGS • Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicide risk (5.1). • Serotonin Syndrome: Risk increases with concomitant use of other serotonergic drugs. Discontinue venlafaxine hydrochloride extended-release capsules and initiate supportive treatment if serotonin syndrome occurs (4.2, 5.2, 7.3). • Elevations in Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment (5.3). • Abnormal Bleeding: Venlafaxine hydrochloride extended-release capsules may increase risk of bleeding events.

Caution patients about the risk of bleeding associated with the concomitant use of venlafaxine hydrochloride extended-release capsules and NSAIDs, aspirin, or other drugs that affect coagulation (5.4). • Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. (5.5). • Activation of Mania/Hypomania: Use cautiously in patients with bipolar disorder. Caution patients about the risk of activation of mania/hypomania (5.6).

5.1Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled studies of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with MDD and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled studies in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 24 short-term studies of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled studies in adults with MDD or other psychiatric disorders included a total of 295 short-term studies (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied.

There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug versus placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1.

No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer term use, i.e., beyond several months.

However, there is substantial evidence from placebo-controlled maintenance studies in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clini…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Hypersensitivity [see Contraindications (4.1)] • Suicidal Thoughts and Behaviors in Children, Adolescents, and Adults [see Warnings and Precautions (5.1)] • Serotonin Syndrome [see Warnings and Precautions (5.2)] • Elevations in Blood Pressure [see Warnings and Precautions (5.3)] • Abnormal Bleeding [see Warnings and Precautions (5.4)] • Angle Closure Glaucoma [see Warnings and Precautions (5.5)] • Activation of Mania/Hypomania [see Warnings and Precautions (5.6)] • Discontinuation Syndrome [see Warnings and Precautions (5.7)] • Seizure [see Warnings and Precautions (5.8)] • Hyponatremia [see Warnings and Precautions (5.9)] • Weight and Height changes in Pediatric Patients [see Warnings and Precautions (5.10)] • Appetite Changes in Pediatric Patients [see Warnings and Precautions (5.11)] • Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions (5.12)] Most common adverse reactions (incidence 5% and at least twice the rate of placebo): nausea, somnolence, dry mouth, sweating, abnormal ejaculation, anorexia, constipation, erectile dysfunction, and libido decreased (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Most Common Adverse Reactions The most commonly observed adverse reactions in the clinical study database in venlafaxine hydrochloride extended-release capsule treated patients in MDD, GAD, SAD, and PD (incidence 5% and at least twice the rate of placebo) were: nausea (30.0%), somnolence (15.3%), dry mouth (14.8%), sweating (11.4%), abnormal ejaculation (9.9%), anorexia (9.8%), constipation (9.3%), impotence (5.3%) and decreased libido (5.1%).

Adverse Reactions Reported as Reasons for Discontinuation of Treatment Combined across short-term, placebo-controlled premarketing studies for all indications, 12% of the 3,558 patients who received venlafaxine hydrochloride extended-release capsules (37.5 to 225 mg) discontinued treatment due to an adverse experience, compared with 4% of the 2,197 placebo-treated patients in those studies. The most common adverse reactions leading to discontinuation in 1% of the venlafaxine hydrochloride extended-release capsule treated patients in the short-term studies (up to 12 weeks) across indications are shown in Table 7.

Common Adverse Reactions in Placebo-controlled Studies The number of patients receiving multiple doses of venlafaxine hydrochloride extended-release capsules during the premarketing assessment for each approved indication is shown in Table 8. The conditions and duration of exposure to venlafaxine in all development programs varied greatly, and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient (venlafaxine tablets only) and outpatient studies, fixed-dose, and titration studies.

The incidences of common adverse reactions (those that occurred in 2% of venlafaxine hydrochloride extended-release capsule treated patients [357 MDD patients, 1,381 GAD patients, 819 SAD patients, and 1,001 PD patients] and more frequently than placebo) in venlafaxine hydrochloride extended-release capsule treated patients in short-term, placebo-controlled, fixed- and flexible-dose clinical studies (doses 37.5 to 225 mg per day) are shown in Table 9. The adverse reaction profile did not differ substantially between the different patient populations.

Other Adverse Reactions Observed in Clinical Studies Body as a whole – Photosensitivity reaction, chills Cardiovascular system – Postural hypotension, syncope, hypotension, tachy…

🔄 Drug Interactions ~2 min read ▾

DRUG INTERACTIONS • Serotonergic Drugs (e.g., MAOIs, triptans, SSRIs, other SNRIs, linezolid, lithium, tramadol, or St. John’s wort): Potential for serotonin syndrome. Careful patient observation is advised (4.2, 5.2, 7.3).

7.1Central Nervous System (CNS)-Active Drugs The risk of using venlafaxine in combination with other CNS-active drugs has not been systematically evaluated. Consequently, caution is advised when venlafaxine hydrochloride extended-release capsules are taken in combination with other CNS-active drugs.

7.2Monoamine Oxidase Inhibitors Adverse reactions, some of which were serious, have been reported in patients who have recently been discontinued from an MAOI and started on antidepressants with pharmacological properties similar to venlafaxine hydrochloride extended-release capsules (SNRIs or SSRIs), or who have recently had SNRI or SSRI therapy discontinued prior to initiation of an MAOI [see Dosage and Administration (2.9), Contraindications (4.2), and Warnings and Precautions (5.2)].

7.3Serotonergic Drugs Based on the mechanism of action of venlafaxine hydrochloride extended-release capsules and the potential for serotonin syndrome, caution is advised when venlafaxine hydrochloride extended-release capsules are coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, SSRIs, other SNRIs, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, tramadol, or St. John’s wort. If concomitant treatment with venlafaxine hydrochloride extended-release capsules and these drugs is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

The concomitant use of venlafaxine hydrochloride extended-release capsules with tryptophan supplements is not recommended [see Dosage and Administration (2.9), Contraindications (4.2), and Warnings and Precautions (5.2)].

7.4Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin) Serotonin release by platelets plays an important role in hemostasis. The use of psychotropic drugs that interfere with serotonin reuptake is associated with the occurrence of upper gastrointestinal bleeding and concurrent use of an NSAID or aspirin may potentiate this risk of bleeding [see Warnings and Precautions (5.4)]. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin.

Patients receiving warfarin therapy should be carefully monitored when venlafaxine hydrochloride extended-release capsules are initiated or discontinued.

7.5Weight Loss Agents The safety and efficacy of venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established. Coadministration of venlafaxine hydrochloride extended-release capsules and weight loss agents is not recommended. Venlafaxine hydrochloride extended-release capsules are not indicated for weight loss alone or in combination with other products.

7.6Effects of Other Drugs on Venlafaxine Hydrochloride Extended-release Capsules Figure 1: Effect of interacting drugs on the pharmacokinetics of venlafaxine and active metabolite O-desmethylvenlafaxine (ODV). Abbreviations: ODV, O-desmethylvenlafaxine; AUC, area under the curve; Cmax, peak plasma concentrations; EM’s, extensive metabolizers; PM’s, poor metabolizers * No dose adjustment on coadministration with CYP2D6 inhibitors (Fig 3 and Metabolism Section 12.3) Figure 1

7.7Effects of Venlafaxine Hydrochloride Extended-release Capsules on Other Drugs Abbreviations: AUC, area under the curve; Cmax, peak plasma concentrations; OH, hydroxyl * Data for 2-OH desipramine were not plotted to enhance clarity; the fold change and 90% CI for Cmax and AUC of 2-OH desipramine were 6.6 (5.5, 7.9) and 4.4 (3.8, 5.0), respectively. Note: *: Administration of venlafaxine in a stable regimen did not exaggerate the psychomotor and psychometric effects induced…

👥 Use in Specific Populations ~3 min read ▾

• Pregnancy: Based on animal data, may cause fetal harm (8.1). • Nursing Mothers: Discontinue drug or nursing, taking into consideration importance of drug to mother (8.3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

8.1Pregnancy Teratogenic Effects – Pregnancy Category C Venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human daily dose on a mg/m2 basis. However, in rats, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known.

These effects occurred at 2.5 times (mg/m2) the maximum human daily dose. The no effect dose for rat pup mortality was 0.25 times the human dose on a mg/m2 basis. In reproductive developmental studies in rats and rabbits with O-desmethylvenlafaxine (ODV), the major human metabolite of venlafaxine, evidence of teratogenicity was not observed at exposure margins of 13 in rats and 0.3 in rabbits.

There are no adequate and well-controlled studies in pregnant women. Venlafaxine hydrochloride extended-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Non-teratogenic Effects Neonates exposed to venlafaxine hydrochloride extended-release capsules, other SNRIs, or SSRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. 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. It should be noted, that in some cases the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7.3)]. When treating a pregnant woman with venlafaxine hydrochloride extended-release capsules during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

8.2Labor and Delivery The effect of venlafaxine on labor and delivery in humans is unknown.

8.3Nursing Mothers Venlafaxine and ODV have been reported to be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from venlafaxine hydrochloride extended-release capsules, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use Two placebo-controlled trials in 766 pediatric patients with MDD and two placebo-controlled trials in 793 pediatric patients with GAD have been conducted with venlafaxine hydrochloride extended-release capsules, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of venlafaxine hydrochloride extended-release capsules in a child or adolescent must balance the potential risks with the clinical need [see Boxed Warning, Warnings and Precautions (5.1, 5.10, 5.11) and Adverse Reactions (6.4)].

Although no studies have been designed to primarily assess venlafaxine hydrochloride extended-release capsules’s impact on the growth, development, and maturation of children and adolescents, the studies that have been done suggest that venlafaxine hydrochloride extended-release capsules may adversely affect weight and height [see Warnings and Precautions (5.10)]. Should the decision be made to treat a p…

🆘 Overdosage ~2 min read ▾

OVERDOSAGE Human Experience During the premarketing evaluations of venlafaxine hydrochloride extended-release capsules (for MDD, GAD, SAD, and PD) and venlafaxine tablets (for MDD), there were twenty reports of acute overdosage with venlafaxine tablets (6 and 14 reports in venlafaxine hydrochloride extended-release capsules and venlafaxine tablet patients, respectively), either alone or in combination with other drugs and/or alcohol. Somnolence was the most commonly reported symptom. Among the other reported symptoms were paresthesia of all four limbs, moderate dizziness, nausea, numb hands and feet, and hot-cold spells 5 days after the overdose.

In most cases, no signs or symptoms were associated with overdose. The majority of the reports involved ingestion in which the total dose of venlafaxine taken was estimated to be no more than several-fold higher than the usual therapeutic dose. One patient who ingested 2.75 g of venlafaxine was observed to have two generalized convulsions and a prolongation of QTc to 500 msec, compared with 405 msec at baseline.

Mild sinus tachycardia was reported in two of the other patients. Actions taken to treat the overdose included no treatment, hospitalization and symptomatic treatment, and hospitalization plus treatment with activated charcoal. All patients recovered.

In postmarketing experience, overdose with venlafaxine has occurred predominantly in combination with alcohol and/or other drugs. The most commonly reported events in overdosage include tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, seizures, and vomiting. Electrocardiogram changes (e.g., prolongation of QT interval, bundle branch block, QRS prolongation), ventricular tachycardia, bradycardia, hypotension, rhabdomyolysis, vertigo, liver necrosis, serotonin syndrome, and death have been reported.

Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants. Epidemiological studies have shown that venlafaxine-treated patients have a higher preexisting burden of suicide risk factors than SSRI-treated patients. The extent to which the finding of an increased risk of fatal outcomes can be attributed to the toxicity of venlafaxine in overdosage, as opposed to some characteristic(s) of venlafaxine-treated patients, is not clear.

Prescriptions for venlafaxine hydrochloride extended-release capsules should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose. Management of Overdosage Consult a Certified Poison Control Center for up-to-date guidance and advice (1-800-222-1222 or www.poison.org). In case of an overdose, provide supportive care, including close medical supervision and monitoring.

Treatment should consist of those general measures employed in the management of overdosage with any drug. Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation.

Monitor cardiac rhythm and vital signs. Provide supportive and symptomatic measures.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY

12.1Mechanism of Action The exact mechanism of the antidepressant action of venlafaxine in humans is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their reuptake. Non- clinical studies have demonstrated that venlafaxine and its active metabolite, ODV, are potent and selective inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake.

12.2Pharmacodynamics Venlafaxine and ODV have no significant affinity for muscarinic-cholinergic, H1-histaminergic, or 1 adrenergic receptors in vitro. Pharmacologic activity at these receptors is hypothesized to be associated with the various anticholinergic, sedative, and cardiovascular effects seen with other psychotropic drugs. Venlafaxine and ODV do not possess monoamine oxidase (MAO) inhibitory activity.

Cardiac Electrophysiology The effect of venlafaxine on the QT interval was evaluated in a randomized, double-blind, placebo-and positive-controlled three-period crossover thorough QT study in 54 healthy adult subjects. No significant QT prolongation effect of venlafaxine 450 mg was detected.

12.3Pharmacokinetics Steady-state concentrations of venlafaxine and ODV in plasma are attained within 3 days of oral multiple-dose therapy. Venlafaxine and ODV exhibited linear kinetics over the dose range of 75 to 450 mg per day. Mean SD steady-state plasma clearance of venlafaxine and ODV is 1.3 0.6 and 0.4

0.2L/h/kg, respectively; apparent elimination half-life is 5 2 and 11 2 hours, respectively; and apparent (steady state) volume of distribution is 7.5 3.7 and 5.7

1.8L/kg, respectively. Venlafaxine and ODV are minimally bound at therapeutic concentrations to plasma proteins (27% and 30%, respectively). Absorption and Distribution Venlafaxine is well absorbed and extensively metabolized in the liver.

ODV is the major active metabolite. On the basis of mass balance studies, at least 92% of a single oral dose of venlafaxine is absorbed. The absolute bioavailability of venlafaxine is approximately 45%.

Administration of venlafaxine hydrochloride extended-release capsules (150 mg once daily) generally resulted in lower Cmax and later Tmax values than for venlafaxine tablets (immediate release) administered twice daily (Table 16). When equal daily doses of venlafaxine were administered as either an immediate-release tablet or the extended-release capsule, the exposure to both venlafaxine and ODV was similar for the two treatments, and the fluctuation in plasma concentrations was slightly lower with the venlafaxine hydrochloride extended-release capsule.

Therefore, venlafaxine hydrochloride extended-release capsules provide a slower rate of absorption, but the same extent of absorption compared with the immediate-release tablet. Food did not affect the bioavailability of venlafaxine or its active metabolite, ODV. Time of administration (AM versus PM) did not affect the pharmacokinetics of venlafaxine and ODV from the 75 mg venlafaxine hydrochloride extended-release capsule.

Venlafaxine is not highly bound to plasma proteins; therefore, administration of venlafaxine hydrochloride extended-release capsules to a patient taking another drug that is highly protein-bound should not cause increased free concentrations of the other drug. Metabolism and Elimination Following absorption, venlafaxine undergoes extensive presystemic metabolism in the liver, primarily to ODV, but also to N-desmethylvenlafaxine, N,O-didesmethylvenlafaxine, and other minor metabolites. In vitro studies indicate that the formation of ODV is catalyzed by CYP2D6; this has been confirmed in a clinical study showing that patients with low CYP2D6 levels (poor metabolizers) had increased levels of venlafaxine and reduced levels of ODV compared to people with normal CYP2D6 levels (extensive metabolizers) [see Use in Specific Populations (8.7)].

Approximately 87% of a venlafaxine d…

📦 How Supplied / Storage and Handling 153 words ▾

HOW SUPPLIED Venlafaxine hydrochloride extended-release capsules USP are available as follows: 37.5 mg - light-gray opaque cap/buff opaque body with “93” and “7384” on both body and cap. They are available in bottles of 30 (NDC 42291-897-30), 90 (NDC 42291-897-90) and 500 (NDC 42291-897-50). 75 mg - buff opaque cap/buff opaque body with “93” and “7385” on both body and cap.

They are available in bottles of 30 (NDC 42291-898-30), 90 (NDC 42291-898-90) and 500 (NDC 42291-898-50). 150 mg - light-orange opaque cap/light-orange opaque body with “93” and “7386” on both body and cap. They are available in bottles of 30 (NDC 42291-899-30), 90 (NDC 42291-899-90) and 500 (NDC 42291-899-50).

Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

📋 Description 188 words ▾

DESCRIPTION Venlafaxine hydrochloride extended-release capsules for oral administration contain venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]- p -methoxybenzyl] cyclohexanol hydrochloride. The structural formula is shown below.

C 17 H 27 NO 2 •HCl M.W. 313.87 Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of

0.2M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent.

Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, dibutyl sebacate, ethylcellulose, gelatin, polyethylene glycol, povidone, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), sunset yellow FCF FD&C yellow 6, talc, and titanium dioxide. The 37.5 mg capsules also contain D&C yellow 10 and potassium hydroxide, the 75 mg capsules also contain D&C yellow 10 and may contain potassium hydroxide, and the 150 mg capsules also contain potassium hydroxide.

Structural formula for venlafaxing hydrochloride

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Venlafaxine (VEN la fax een) Hydrochloride Extended-Release Capsules USP Read the Medication Guide that comes with venlafaxine hydrochloride extended-release capsules before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about venlafaxine hydrochloride extended- release capsules? Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may cause serious side effects, including: 1.

Suicidal thoughts or actions: • Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice: • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. • Pay particular attention to such changes when venlafaxine hydrochloride extended-release capsules are started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: • attempts to commit suicide • acting on dangerous impulses • acting aggressive or violent • thoughts about suicide or dying • new or worse depression • new or worse anxiety or panic attacks • feeling agitated, restless, angry or irritable • trouble sleeping • an increase in activity or talking more than what is normal for you • other unusual changes in behavior or mood • Visual problems eye pain changes in vision swelling or redness in or around the eye • Only some people are at risk for these problems.

You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Venlafaxine hydrochloride extended-release capsules may be associated with these serious side effects: 2.

Serotonin Syndrome • This condition can be life-threatening and may include: • agitation, hallucinations, coma or other changes in mental status • coordination problems or muscle twitching (overactive reflexes) • racing heartbeat, high or low blood pressure • sweating or fever • nausea, vomiting, or diarrhea • muscle rigidity 3. Changes in blood pressure. Venlafaxine hydrochloride extended-release capsules may: • increase your blood pressure.

Control high blood pressure before starting treatment and monitor blood pressure regularly 4. Enlarged pupils (mydriasis). 5.

Anxiety and insomnia. 6. Changes in appetite or weight.

7. Manic/hypomanic episodes: • greatly increased energy • severe trouble sleeping • racing thoughts • reckless behavior • unusually grand ideas • excessive happiness or irritability • talking more or faster than usual 8. Low salt (sodium) levels in the blood.

Elderly people may be at greater risk for this. Symptoms may include: • headache • weakness or feeling unsteady • confusion, problems concentrating or thinking or memory problems 9. Seizures or convulsions.

10. Abnormal bleeding: Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin , Jantoven ), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or asp…

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