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Desvenlafaxine ER 50 mg Tablet, Extended Release, 30-count — NDC 72189-0567-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Desvenlafaxine ER 50 mg Tablet, Extended Release, 30-count — NDC 72189-567-30 (Billing 72189-0567-30)

by Direct_rx · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 30 tablets of Desvenlafaxine ER 50 mg Tablet, Extended Release from Direct_rx, marketed since Jul 2024 and currently FDA-listed.

NDC 72189-0567-30
🏷️ FDA NDC (as labeled) 72189-567-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.7941/unit — full pricing hub ↓
Product page 72189-0567-28 Also comes in: 28 tablets 72189-567-28 60 tablets 72189-567-60
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-567-30
Product NDC 72189-567
11-digit billing NDC 72189056730
NCPDP billing unit EA — each (per item)
RxCUI 1874559
UNII ZB22ENF0XR
Application # ANDA204028
SPL Set ID 1d86d1dc-d685-43aa-e063-6294a90a9907
Established class (EPC) Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of action Cytochrome P450 2D6 Inhibitors; 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 2024-07-18
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance DESVENLAFAXINE SUCCINATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 063736
GCN 99451
HICL code 035420
Ingredient (HICL) Desvenlafaxine Succinate
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 DESVENLAFAXINE SUCCNT ER 50 MG
FDB brand name Desvenlafaxine Succinate Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 063736
  • GCN: 99451
  • HICL (First Databank): 035420
  • AHFS class code: 28:16.04.16
  • RxCUI (RxNorm): 1874559
Why two NDCs? The FDA registers this code as 72189-567-30 — 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 → 72189-0567-30. 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, Cytochrome P450 2D6 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.

Clinical

Label name DESVENLAFAXINE SUCCNT ER 50 MG Ingredient Desvenlafaxine Succinate
📖 What it is MedlinePlus · NLM

Desvenlafaxine is used to treat depression. Desvenlafaxine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amounts of serotonin and norepinephrine, natural substances in the brain that help maintain mental balance.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats major depressive disorder in adults. It is an SNRI, which works on the brain chemicals serotonin and norepinephrine.
  • Take one tablet by mouth once a day at about the same time, with or without food. Swallow it whole with fluid. Don't split, crush or chew it. Follow your prescriber's directions.
  • Nausea, dizziness, trouble sleeping, sweating, constipation, sleepiness, dry mouth and lower appetite are common. Sexual side effects can also happen. Call your doctor if they are...
  • Please don't stop suddenly. Stopping abruptly can cause discontinuation symptoms, so your prescriber will usually lower the dose gradually.
📖 Read our full Desvenlafaxine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 $0.7941 $23.82 / 30 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72189-0567-28 72189-567-28 Main listing 28 TABLET, EXTENDED RELEASE in 1 BOTTLE 2024-07-18 — Active
72189-0567-30 You're viewing this 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 2024-07-18 — Active
72189-0567-60 72189-567-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE 2024-07-18 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet, extended release in 1 bottle.
How does this package differ from NDC 72189-0567-28?
Both are Desvenlafaxine ER 50 mg Tablet, Extended Release — the drug itself is identical. This page's package is the 30-count one, while NDC 72189-0567-28 is the 28 tablets package.
What NDC number is used to bill for this package of Desvenlafaxine ER 50 mg Tablet, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Desvenlafaxine 50 mg 00054-0400-13 Hikma 30 tablets $0.396 AB Availability likely —
Desvenlafaxine 50 mg 00591-3659-30 Actavis 30 tablets $0.396 AB Availability likely —
Desvenlafaxine Succinate 50 mg 33342-0388-07 Macleods 30 tablets $0.396 AB Availability likely —
Desvenlafaxine 50 mg 60687-0607-21 American 1 tablet $0.396 — Availability likely —
Desvenlafaxine 50 mg 70436-0012-04 Slate 30 tablets $0.396 AB Availability likely —
Desvenlafaxine 50 mg 72603-0556-01 NorthStar 30 tablets $0.396 AB Availability likely —
Pristiq Extended-Release 50 mg 00008-1211-01 Wyeth 90 tablets $13.963 AB Availability likely —
Desvenlafaxine 50 mg 10135-0821-10 Marlex 1000 tablets — AB FDA listed —
Desvenlafaxine 50 mg 46708-0540-10 Alembic 100 tablets — AB FDA listed —
Desvenlafaxine 50 mg 50090-4806-00 A-S 30 tablets — — FDA listed —
Desvenlafaxine 50 mg 50090-5293-00 A-S 30 tablets — AB FDA listed —
Desvenlafaxine Succinate 50 mg 50090-6894-00 A-S 30 tablets — AB FDA listed —
Desvenlafaxine 50 mg 50090-7737-00 A-S 30 tablets — AB FDA listed —
Desvenlafaxine 50 mg 51991-0311-01 Breckenridge 100 tablets — AB FDA listed —
Desvenlafaxine Er 50 mg 61919-0882-28 Direct_Rx 28 tablets — AB FDA listed —
Desvenlafaxine 50 mg 63629-7525-01 Bryant 30 tablets — AB FDA listed —
Desvenlafaxine 50 mg 68071-3790-03 NuCare 30 tablets — AB FDA listed —
Desvenlafaxine Succinate 50 mg 68180-0592-02 Lupin 500 tablets — AB FDA listed —
Desvenlafaxine 50 mg 68788-7194-01 Preferred 100 tablets — AB FDA listed —
Desvenlafaxine 50 mg 68788-8760-01 Preferred 100 tablets — AB FDA listed —
Desvenlafaxine Succinate 50 mg 71335-1150-01 Bryant 30 tablets — AB FDA listed —
Desvenlafaxine 50 mg 71335-1700-01 Bryant 30 tablets — — FDA listed —
Desvenlafaxine 50 mg 71335-1753-01 Bryant 30 tablets — AB FDA listed —
Desvenlafaxine 50 mg 71335-2575-01 Bryant 30 tablets — AB FDA listed —
desvenlafaxine 50 mg 72189-0147-28 DIRECT 28 tablets — AB FDA listed —
Desvenlafaxine ER 50 mgthis 72189-0567-30 Direct_rx 30 tablets — AB FDA listed —
Desvenlafaxine 50 mg 72888-0143-00 Advagen 1000 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

🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 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.

What it looks like

Color pink
ShapeRound
ImprintUpArrowhead;A42
Size1 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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 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.

9 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.

Manufacturer & labeler

LabelerDirect_rx
Application holderRUBICON RESEARCH LTD
FDA applicationANDA204028 (ANDA)
Labeler code72189
First marketedJul 2024
Product typeHuman Prescription Drug
Portfolio355 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Medication Guide 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 128 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS 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 worsening, and for 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)] . Desvenlafaxine extended-release tabletsare not approved for use in pediatric patients [see USE IN SPECIFIC POPULATIONS (8.4)] .

🎯 Indications and Usage 19 words ▾

Desvenlafaxine extended-release tablets are indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].

⏱️ Dosage and Administration ~3 min read ▾

2.1General Instructions for Use The recommended dose for desvenlafaxine extended-release tablets is 50 mg once daily, with or without food. The 50 mg dose is both a starting dose and the therapeutic dose. Desvenlafaxine extended-release tablets should be taken at approximately the same time each day.

Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved. In clinical studies, doses of 10 mg to 400 mg per day were studied. In clinical studies, doses of 50 mg to 400 mg per day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg per day and adverse reactions and discontinuations were more frequent at higher doses.

The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment. When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimize discontinuation symptoms [see DOSAGE AND ADMINISTRATION (2.5)and WARNINGS AND PRECAUTIONS (5.7)].

2.2Dosage Recommendations for Patients with Renal Impairment The maximum recommended dose in patients with moderate renal impairment (24-hr creatinine clearance [ClCr] = 30 to 50 mL/min, Cockcroft-Gault [C-G]) is 50 mg per day. The maximum recommended dose in patients with severe renal impairment (ClCr 15 to 29 mL/min, C-G) or end- stage renal disease (ESRD, ClCr < 15 mL/min, C-G) is 25 mg every day or 50 mg every other day. Supplemental doses should not be given to patients after dialysis [see USE IN SPECIFIC POPULATIONS (8.6)and CLINICAL PHARMACOLOGY (12.3)] .

2.3Dosage Recommendations for Patients with Hepatic Impairment The recommended dose in patients with moderate to severe hepatic impairment (Child-Pugh score 7 to 15) is 50 mg per day. Dose escalation above 100 mg per day is not recommended [see USE IN SPECIFIC POPULATIONS (8.7)and CLINICAL PHARMACOLOGY (12.3)] .

2.4Maintenance/Continuation/Extended Treatment It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Longer-term efficacy of desvenlafaxine extended-release tablets (50-400 mg) was established in two maintenance trials [see CLINICAL STUDIES (14)] . Patients should be periodically reassessed to determine the need for continued treatment.

2.5Discontinuing Desvenlafaxine Extended-Release Tablets Adverse reactions may occur upon discontinuation of desvenlafaxine extended-release tablets [see WARNINGS AND PRECAUTIONS (5.7)]. Gradually reduce the dosage rather than stopping desvenlafaxine extended-release tablets abruptly when discontinuing therapy with desvenlafaxine extended-release tablets. In some patients, discontinuation may need to occur over a period of several months.

2.6Switching Patients from Other Antidepressants to Desvenlafaxine Extended-Release Tablets Discontinuation symptoms have been reported when switching patients from other antidepressants, including venlafaxine, to desvenlafaxine extended-release tablets. Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms.

2.7Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with desvenlafaxine extended-release tablets. Conversely, at least 7 days should be allowed after stopping desvenlafaxine extended-release tablets before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS (4)].

2.8Use of Desvenlafaxine Extended-Release Tablets with other MAOIs such as Linezolid or Methylene Blue Do not start desvenlafaxine extended-release tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 72 words ▾

25 mg Tablet: Brown colored, round shaped convex, film coated tablet debossed with "˄" on one side and plain on the other side. A41 50 mg Tablet: Pink colored, round shaped convex, film coated tablet debossed with "˄" on one side and plain on the other side. A42 100 mg Tablet: Beige colored, round shaped convex, film coated tablet debossed with "˄" on one side and plain on the other side. A43

⛔ Contraindications 136 words ▾

Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine extended-release tablets formulation. Angioedema has been reported in patients treated with desvenlafaxine extended-release tablets [see ADVERSE REACTIONS (6.1)] . The use of MAOIs intended to treat psychiatric disorders with desvenlafaxine extended-release tablets or within 7 days of stopping treatment with desvenlafaxine extended-release tablets is contraindicated because of an increased risk of serotonin syndrome.

The use of desvenlafaxine extended-release tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see DOSAGE AND ADMINISTRATION (2.7)and WARNINGS AND PRECAUTIONS (5.2)]. Starting desvenlafaxine extended-release tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see DOSAGE AND ADMINISTRATION (2.8)and WARNINGS AND PRECAUTIONS (5.2)].

⚠️ Warnings and Cautions ~3 min read ▾

5.1Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients Patients with 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 major depressive disorder (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 vs. 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. Table 1 Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 Patients Treated Increases Compared to Placebo <18 14 additional cases 18 to 24 5 additional cases Decreases Compared to Placebo 25 to 64 1 fewer case ≥65 6 fewer cases 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 major depressive disorder 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 g… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see CONTRAINDICATIONS (4)] Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [see WARNINGS AND PRECAUTIONS (5.1)] Serotonin Syndrome [see WARNINGS AND PRECAUTIONS (5.2)] Elevated Blood Pressure [see WARNINGS AND PRECAUTIONS (5.3)] Increased Risk of 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)] Interstitial Lung Disease and Eosinophilic Pneumonia [see WARNINGS AND PRECAUTIONS (5.10)] Sexual Dysfunction [see WARNINGS AND PRECAUTIONS (5.11)]

6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Patient Exposure Desvenlafaxine extended-release tablets were evaluated for safety in 8,394 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 2,784 patient-years of exposure.

Of the total 8,394 patients exposed to at least one dose of desvenlafaxine extended-release tablets; 2,116 were exposed to desvenlafaxine extended-release tablets for 6 months, representing 1,658 patient-years of exposure, and 421 were exposed for one year, representing 416 patient-years of exposure. Adverse Reactions Reported as Reasons for Discontinuation of Treatment In the pre-marketing pooled 8-week placebo-controlled studies in patients with MDD, 1,834 patients were exposed to desvenlafaxine extended-release tablets (50 to 400 mg).

Of the 1,834 patients, 12% discontinued treatment due to an adverse reaction, compared with 3% of the 1,116 placebo-treated patients. At the recommended dose of 50 mg, the discontinuation rate due to an adverse reaction for desvenlafaxine extended-release tablets (4.1%) was similar to the rate for placebo (3.8%). For the 100 mg dose of desvenlafaxine extended-release tablets the discontinuation rate due to an adverse reaction was 8.7%.

The most common adverse reactions leading to discontinuation in at least 2% and at a rate greater than placebo of the desvenlafaxine extended-release tablets treated patients in the short-term studies, up to 8 weeks, were: nausea (4%); dizziness, headache and vomiting (2% each). In a longer-term study, up to 9 months, the most common was vomiting (2%). Common Adverse Reactions in Placebo-Controlled MDD Studies The most commonly observed adverse reactions in desvenlafaxine extended-release tablets treated MDD patients in pre- marketing pooled 8-week, placebo-controlled, fixed-dose studies (incidence ≥ 5% and at least twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.

Table 2 shows the incidence of common adverse reactions that occurred in ≥ 2% of desvenlafaxine extended-release tablets treated MDD patients and twice the rate of placebo at any dose in the pre-marketing pooled 8-week, placebo-controlled, fixed dose clinical studies. Table 2: Common Adverse Reactions (≥ 2% in any Fixed-Dose Group and Twice the Rate of Placebo) in Pre-marketing Pooled MDD 8-Week Placebo-Controlled Studies Percentage of Patients Reporting Reaction Desvenlafaxine Extended-Release Tablets System Organ Class Preferred Term Placebo (n=636) 50 mg (n=317) 100 mg (n=424) 200 mg (n=307) 400 mg (n=317) Cardiac disorders Blood pressure increased 1 1 1 2 2 Gastrointestinal disorders Nausea 10 22 26 36 41 Dry mouth 9 11 17 21 25 Constipation 4 9 9 10 14 Vom… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7.1Drugs Having Clinically Important Interactions with Desvenlafaxine Extended-Release Tablets Table 8: Clinically Important Drug Interactions with Desvenlafaxine Extended-Release Tablets Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SSRIs and SNRIs including desvenlafaxine extended-release tablets with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of desvenlafaxine extended-release tablets is contraindicated: With an MAOI intended to treat psychiatric disorders or within 7 days of stopping treatment with desvenlafaxine extended-release tablets.

Within 14 days of stopping an MAOI intended to treat psychiatric disorders. In a patient who is being treated with linezolid or intravenous methylene blue. [see DOSAGE AND ADMINISTRATION (2.7), CONTRAINDICATIONS (4)and WARNINGS AND PRECAUTIONS (5.2)]. Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact Concomitant use of desvenlafaxine extended-release tablets with other serotonergic drugs increases the risk of serotonin syndrome.

Intervention Monitor for symptoms of serotonin syndrome when desvenlafaxine extended-release tablets are used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of desvenlafaxine extended-release tablets and/or concomitant serotonergic drugs [see WARNINGS AND PRECAUTIONS (5.2)]. Examples other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St.

John's Wort Drugs that Interfere with Hemostasis Clinical Impact Concomitant use of desvenlafaxine extended-release tablets with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. This may be due to the effect of desvenlafaxine extended-release tablets on the release of serotonin by platelets. Intervention Closely monitor for bleeding for patients receiving an antiplatelet or anticoagulant drug when desvenlafaxine extended-release tablets are initiated or discontinued [see WARNINGS AND PRECAUTIONS (5.4)] .

Examples NSAIDs, aspirin, and warfarin Drugs that are Primarily Metabolized by CYP2D6 Clinical Impact Concomitant use of desvenlafaxine extended-release tablets increases Cmax and AUC of a drug primarily metabolized by CYP2D6 which may increase the risk of toxicity of the CYP2D6 substrate drug [see CLINICAL PHARMACOLOGY (12.3)] . Intervention Original dose should be taken when co-administered with desvenlafaxine extended-release tablets 100 mg or lower. Reduce the dose of these drugs by up to one-half if co-administered with 400 mg of desvenlafaxine extended-release tablets.

Examples desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine

7.2Drugs Having No Clinically Important Interactions with Desvenlafaxine Extended-Release Tablets Based on pharmacokinetic studies, no dosage adjustment is required for drugs that are mainly metabolized by CYP3A4 (e.g., midazolam), or for drugs that are metabolized by both CYP2D6 and CYP3A4 (e.g., tamoxifen, aripiprazole), when administered concomitantly with desvenlafaxine extended-release tablets [see CLINICAL PHARMACOLOGY (12.3)].

7.3Alcohol A clinical study has shown that desvenlafaxine extended-release tablets does not increase the impairment of mental and motor skills caused by ethanol. However, as with all CNS-active drugs, patients should be advised to avoid alcohol consumption while taking desvenlafaxine extended-release tablets.

7.4Drug-Laboratory Test Interactions False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking desvenlafaxine. This is due to lack of specificity of the screening tests. False positive test results may be expected for several days following discontinuation of desvenlafaxine therapy. Confirmatory tests, such as gas chromatograp… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

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 register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185. Risk Summary Based on data from published observational studies, exposure to SNRIs, 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 (5.4)and Clinical Considerations].

There are no published studies on desvenlafaxine extended-release tablets in pregnant women; however published epidemiologic studies of pregnant women exposed to venlafaxine, the parent compound, have not reported a clear association with adverse developmental outcomes (see Data). There are risks associated with untreated depression in pregnancy and with exposure to SNRIs and SSRIs, including desvenlafaxine extended-release tablets, during pregnancy ( see Clinical Considerations). In reproductive developmental studies in rats and rabbits treated with desvenlafaxine succinate, there was no evidence of teratogenicity at a plasma exposure (AUC) that is up to 19-times (rats) and 0.5-times (rabbits) the exposure at an adult human dose of 100 mg per day.

However, fetotoxicity and pup deaths were observed in rats at 4.5-times the AUC exposure observed with an adult human dose of 100 mg per day. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk A prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy, showed that women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.

Maternal Adverse Reactions Exposure to desvenlafaxine extended-release tablets in mid to late pregnancy may increase the risk for preeclampsia, and exposure to desvenlafaxine extended-release tablets in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see WARNINGS AND PRECAUTIONS (5.4)]. Fetal/Neonatal Adverse Reactions Exposure to SNRIs or SSRIs in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding.

Monitor neonates who were exposed to desvenlafaxine extended-release tablets in the third trimester of pregnancy for drug discontinuation syndrome (see Data). Data Human Data Published epidemiological studies of pregnant women exposed to the parent compound venlafaxine have not reported a clear association with major birth defects or miscarriage. Methodological limitations of these observational studies include possible exposure and outcome misclassification, lack of adequate controls, adjustment for confounders, and confirmatory studies; therefore, these studies cannot establish or exclude any drug-associated risk during pregnancy.

Retrospective cohort studies based on claims data have shown an association between venlafaxine use and preeclampsia, compared to depressed women who did not take an antidepressant during pregnancy. One study that assessed venlafaxine exposure in the second trimester or first half of the third trimester and preeclampsia showed an increased risk compared to unexposed depressed women [adjusted (adj) RR 1.57, 95% CI 1.29-1.91]. Preeclampsia was observed at venlafaxine doses equal to or greater than 75 mg/day and a duration of treatment >30 days.

Another… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage ~1 min read ▾

10.1Human Experience with Overdosage There is limited clinical trial experience with desvenlafaxine succinate overdosage in humans. However, desvenlafaxine is the major active metabolite of venlafaxine. Overdose experience reported with venlafaxine (the parent drug of desvenlafaxine extended-release tablets) is presented below; the identical information can be found in the Overdosage section of the venlafaxine package insert.

In postmarketing experience, overdose with venlafaxine (the parent drug of desvenlafaxine extended-release tablets) 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), sinus and 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 pre-existing 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.

10.2Management of Overdosage No specific antidotes for desvenlafaxine extended-release tablets are known. In managing over dosage, consider the possibility of multiple drug involvement. In case of overdose, call Poison Control Center at 1-800-222-1222 for latest recommendations.

🧬 Clinical Pharmacology ~2 min read ▾

12.1Mechanism of Action The exact mechanism of the antidepressant action of desvenlafaxine 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 shown that desvenlafaxine is a potent and selective SNRI.

12.2Pharmacodynamics Desvenlafaxine lacked significant affinity for numerous receptors, including muscarinic-cholinergic, H1-histaminergic, or α1-adrenergic receptors in vitro. Desvenlafaxine also lacked monoamine oxidase (MAO) inhibitory activity. ECG changes Electrocardiograms were obtained from 1,492 desvenlafaxine treated patients with major depressive disorder and 984 placebo-treated patients in clinical studies lasting up to 8 weeks.

No clinically relevant differences were observed between desvenlafaxine treated and placebo-treated patients for QT, QTc, PR, and QRS intervals. In a thorough QTc study with prospectively determined criteria, desvenlafaxine did not cause QT prolongation. No difference was observed between placebo and desvenlafaxine treatments for the QRS interval.

12.3Pharmacokinetics The single-dose pharmacokinetics of desvenlafaxine are linear and dose-proportional in a dose range of 50 to 600 mg (1 to 12 times the recommended approved dosage) per day. With once-daily dosing, steady-state plasma concentrations are achieved within approximately 4 to 5 days. At steady-state, multiple-dose accumulation of desvenlafaxine is linear and predictable from the single-dose pharmacokinetic profile.

Absorption The absolute oral bioavailability of desvenlafaxine extended-release tablets after oral administration is about 80%. Effect of Food Ingestion of a high-fat meal (800 to 1000 calories) increased desvenlafaxine Cmax about 16% and had no effect on AUC. Distribution Steady-state volume of distribution of desvenlafaxine is

3.4L/kg. Plasma protein binding of desvenlafaxine is 30% and is independent of drug concentration. Elimination Metabolism Desvenlafaxine is primarily metabolized by conjugation (mediated by UGT isoforms) and, to a minor extent, through oxidative metabolism.

CYP3A4 mediates the oxidative metabolism (N-demethylation) of desvenlafaxine. The CYP2D6 metabolic pathway is not involved. The pharmacokinetics of desvenlafaxine was similar in subjects with CYP2D6 poor and extensive metabolizer phenotype.

Excretion Approximately 45% of desvenlafaxine is excreted unchanged in urine at 72 hours after oral administration. Approximately 19% of the administered dose is excreted as the glucuronide metabolite and <5% as the oxidative metabolite (N,O-didesmethylvenlafaxine) in urine. Specific Populations No clinically significant differences in the exposures of desvenlafaxine were observed based on ethnicity (White, Black, Hispanic).

The effect of intrinsic patient factors on the pharmacokinetics of desvenlafaxine is presented in Figure 1. Figure 1 Impact of Intrinsic Factors (Renal, Hepatic Impairment and Population Description) on Desvenlafaxine Pharmacokinetics [image description] Drug Interaction Studies Clinical Studies Other Drugs on desvenlafaxine extended-release tablets The effect of ketoconazole on the exposures of desvenlafaxine is summarized in Figure 2. Figure 2.

Effect of Other Drugs on Desvenlafaxine Pharmacokinetics [image description] Desvenlafaxine extended-release tablets on Other Drugs The effects of desvenlafaxine extended-release tablets on the exposures of other drugs are summarized in Figure 3. Figure 3. Effects of desvenlafaxine extended-release tablets on Pharmacokinetics of Other Drugs [image description] In Vitro Studies Based on in vitrodata, drugs that inhibit CYP isozymes 1A1, 1A2, 2A6, 2D6, 2C8, 2C9, 2C19, and 2E1 are not expected to have significant impact on the pharmacokinetic profile of desvenlafaxine.

Desvenlafaxine does not inhibit CYP1A2, 2A6, 2C8, 2C9, 2C19 CYP2D6, or CYP3A4 isozymes. Desvenlafaxine does not induce CYP3A4 either. Desvenlafaxine… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 148 words ▾

Desvenlafaxine extended-release tablets are available as follows: 25 mg, brown colored, round shaped convex, film coated tablet debossed with "˄" on one side and plain on the other side A41 NDC 72888-175-30, bottle of 30 tablets NDC 72888-175-90, bottle of 90 tablets NDC 72888-175-05, bottle of 500 tablets NDC 72888-175-00, bottle of 1000 tablets 50 mg, pink colored, round shaped convex, film coated tablet debossed with "˄" on one side and plain on the other side A42 NDC 72189-567-60, bottle of 60 tablets NDC 72888-143-90, bottle of 90 tablets NDC 72888-143-05, bottle of 500 tablets NDC 72888-143-00, bottle of 1000 tablets 100 mg, beige colored, round shaped convex, film coated tablet debossed with "˄" on one side and plain on the other side A43 NDC 72888-144-30, bottle of 30 tablets NDC 72888-144-90, bottle of 90 tablets NDC 72888-144-05, bottle of 500 tablets NDC 72888-144-00, bottle of 1000 tablets

📦 Storage and Handling 47 words ▾

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively.

📋 Description ~1 min read ▾

Desvenlafaxine extended-release tablets are an extended-release tablets for oral administration that contain desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2(free base) and C 16H 25NO 2•C 4H 6O 4•H 2O (succinate monohydrate).

Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. [image description] Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent.

Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine extended-release tablets are formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively.

Inactive ingredients for the 25 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide yellow and iron oxide red. Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, FD&C Red #40 and FD&C Yellow #6. Inactive ingredients for the 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide yellow, iron oxide red and iron oxide black.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Desvenlafaxine(des VEN la FAX een ) Extended-Release Tablets What is the most important information I should know about desvenlafaxine extended-release tablets? Desvenlafaxine extended-release tablets can cause serious side effects, including: Increased risk of suicidal thoughts or actions in some children and young adults within the first few months of treatment. Desvenlafaxine extended-release tablets are not for use in children.

Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

This is very important when an antidepressant medicine is started or when the dose is changed. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with the healthcare provider as scheduled.

Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: o thoughts about suicide or dying o trouble sleeping (insomnia) o attempts to commit suicide o new or worse irritability o new or worse depression o acting aggressive, being angry, or violent o new or worse anxiety o acting on dangerous impulses o feeling very agitated or restless o an extreme increase in activity and talking (mania) o panic attacks o other unusual changes in behavior or mood What are desvenlafaxine extended-release tablets?

Desvenlafaxine extended-release tablets are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD). Desvenlafaxine extended-release tablets belongs to a class of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRIs). Do not take desvenlafaxine extended-release tablets if you: are allergic to desvenlafaxine succinate, venlafaxine hydrochloride, or any of the ingredients in desvenlafaxine extended-release tablets.

See the end of this Medication Guide for a complete list of ingredients in desvenlafaxine extended-release tablets. take a monoamine oxidase inhibitor (MAOI). have stopped taking an MAOI in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI. are being treated with the antibiotic linezolid or the intravenous methylene blue. Do not start taking an MAOI for at least 7 days after you stop treatment with desvenlafaxine extended-release tablets.

Before taking desvenlafaxine extended-release tablets tell your healthcare provider about all your medical conditions, including if you: have high blood pressure have heart problems have cerebrovascular problems or had a stroke have or had bleeding problems have, or have a family history of, bipolar disorder, mania or hypomania have high cholesterol or high triglycerides have or had depression, suicidal thoughts or behavior have kidney or liver problems have or had seizures or convulsions have low sodium levels in your blood are pregnant or plan to become pregnant.

Talk to your healthcare provider about the risk to your unborn baby if you take desvenlafaxine extended-release tablets during pregnancy. Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with desvenlafaxine extended-release tablets. If you become pregnant during treatment with desvenlafaxine extended-release tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants.

You can register by calling 1-844-405-6185. are breastfeeding or plan to breastfeed. Desvenlafaxine can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with desvenlafaxine extended-release table… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

Major Depressive Disorder The efficacy of desvenlafaxine extended-release tablets as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose studies (at doses of 50 mg per day to 400 mg per day) in adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder. In the first study, patients received 100 mg (n = 114), 200 mg (n = 116), or 400 mg (n = 113) of desvenlafaxine extended-release tablets once daily, or placebo (n = 118).

In a second study, patients received either 200 mg (n = 121) or 400 mg (n = 124) of desvenlafaxine extended-release tablets once daily, or placebo (n = 124). In two additional studies, patients received 50 mg (n = 150 and n = 164) or 100 mg (n = 147 and n = 158) of desvenlafaxine extended-release tablets once daily, or placebo (n = 150 and n = 161). Desvenlafaxine extended-release tablets showed superiority over placebo as measured by improvement in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score in four studies and overall improvement, as measured by the Clinical Global Impressions Scale - Improvement (CGI-I), in three of the four studies.

In studies directly comparing 50 mg per day and 100 mg per day there was no suggestion of a greater effect with the higher dose and adverse reactions and discontinuations were more frequent at higher doses [see DOSAGE AND ADMINISTRATION (2.1)] . Table 9: Primary Efficacy (HAM-D 17) Results for Short-term Studies Desvenlafaxine Extended-Release Tablets Study No. Primary Endpoint: HAM-D 17 Placebo 50 mg/day 100 mg/day 200 mg/day 400 mg/day 1 Baseline Score (SD a) 23.1 (2.5) 23.2 (2.5) 22.9 (2.4) 23 (2.2) Difference from Placebo (95% CI c) -2.9 b(-5.1, -0.8) -2.0 -3.1 b (-5.2, -0.9) 2 Baseline Score (SD a) 25.3 (3.3) 24.8 (2.9) 25.2 (3.2) Difference from Placebo (95% CI c) -3.3 b -2.8 b (-5.3, -1.2) (-4.8, -0.7) 3 Baseline Score (SD a) 23 (2.6) 23.4 (2.6) 23.4 (2.6) Difference from Placebo (95% CI c) -1.9 b -1.5 (-3.5, -0.3) 4 Baseline Score (SD a) 24.3 (2.6) 24.3 (2.4) 24.4 (2.7) Difference from Placebo (95% CI c) -2.5 b -3 b (-4.1, -0.9) (-4.7, -1.4) a Standard deviation; b Adjusted p-value < 0.05; c Difference between least squares means at final evaluation, calculated as drug response minus placebo response; unadjusted 95% confidence intervals Analyses of the relationships between treatment outcome and age and treatment outcome and gender did not suggest any differential responsiveness on the basis of these patient characteristics.

There was insufficient information to determine the effect of race on outcome in these studies. In a longer-term trial (Study 5), adult outpatients meeting DSM-IV criteria for major depressive disorder, who responded to 8 weeks of open-label acute treatment with 50 mg per day desvenlafaxine and subsequently remained stable for 12 weeks on desvenlafaxine, were assigned randomly in a double-blind manner to remain on active treatment or switch to placebo for up to 26 weeks of observation for relapse. Response during the open-label phase was defined as a HAM-D17 total score of ≤ 11 and CGI-I ≤ 2 at the day 56 evaluation; stability was defined as HAM-D17 total score of ≤ 11 and CGI-I ≤ 2 at week 20 and not having a HAM-D17 total score of ≥ 16 or a CGI-I score ≥ 4 at any office visit.

Relapse during the double-blind phase was defined as follows: (1) a HAM-D17 total score of ≥ 16 at any office visit, (2) discontinuation for unsatisfactory efficacy response, (3) hospitalized for depression, (4) suicide attempt, or (5) suicide. Patients receiving continued desvenlafaxine treatment experienced statistically significantly longer time to relapse compared with placebo. At 26 weeks, the Kaplan-Meier estimated proportion of relapse was 14% with desvenlafaxine treatment versus 30% with placebo.

Figure 4. Estimated Proportion of Relapses vs. Number of Days since Randomization (Study 5) [image description]… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 11 words ▾

9.1Controlled Substance Desvenlafaxine extended-release tablet is not a controlled substance.

🧪 Nonclinical Toxicology ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Desvenlafaxine succinate administered by oral gavage to mice and rats for 2 years did not increase the incidence of tumors in either study. Mice received desvenlafaxine succinate at dosages up to 500/300 mg/kg/day (dosage lowered after 45 weeks of dosing). The AUC exposure at 300 mg/kg/day dose is estimated at 10 times the AUC exposure at an adult human dose of 100 mg per day.

Rats received desvenlafaxine succinate at dosages up to 300 mg/kg/day (males) or 500 mg/kg/day (females). The AUC exposure at the highest dose is estimated at 11 (males) or 26 (females) times the AUC exposure at an adult human dose of 100 mg per day. Mutagenesis Desvenlafaxine was not mutagenic in the in vitrobacterial mutation assay (Ames test) and was not clastogenic in an in vitrochromosome aberration assay in cultured CHO cells, an in vivomouse micronucleus assay, or an in vivochromosome aberration assay in rats.

Additionally, desvenlafaxine was not genotoxic in the in vitroCHO mammalian cell forward mutation assay and was negative in the in vitroBALB/c-3T3 mouse embryo cell transformation assay. Impairment of Fertility When desvenlafaxine succinate was administered orally to male and female rats, fertility was reduced at the high dose of 300 mg/kg/day, which is 10 (males) and 19 (females) times the AUC exposure at an adult human dose of 100 mg per day. There was no effect on fertility at 100 mg/kg/day, which is 3 (males) or 5 (females) times the AUC exposure at an adult human dose of 100 mg per day.

These studies did not address reversibility of the effect on fertility. The relevance of these findings to humans is not known.

📄 Package Label / Principal Display Panel 3 words ▾

72189-0567-60

72189-567-28

72189-567-30

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

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

Medicare Part D (outpatient prescription) spending for Desvenlafaxine ER — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Desvenlafaxine ER. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$544.6K
Claims incl. refills
3K
Beneficiaries
2K
Spend / beneficiary
$273.83
Spend / claim
$182.10
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

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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.
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Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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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 Direct_rx. 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 28 tablets (72189-0567-28), 60 tablets (72189-0567-60). 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?
Direct_rx 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.
← 72189-0565-60 · Direct_rx 72189-0568-30 · Direct_rx →
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.