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  4. NDC Product Code: 61919-848 Venlafaxine Hydrochloride

NDC 61919-848 Venlafaxine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 61919-848?
  5. Venlafaxine Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
61919-848
Proprietary Name:
Venlafaxine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Direct Rx
Labeler Code:
61919
Product Label ID:
3cfc589e-455e-4df3-91e6-6cfece5c420a
Start Marketing Date: [9]
01-01-2014
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331)
Shape:
CAPSULE (C48336)
Size(s):
22 MM
Imprint(s):
EFFEXORXR;150
Score:
1

Product Packages

NDC Code 61919-848-30

Package Description: 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Product Details

What is NDC 61919-848?

The NDC code 61919-848 is assigned by the FDA to the product Venlafaxine Hydrochloride which is product labeled by Direct Rx. The product's dosage form is . The product is distributed in a single package with assigned NDC code 61919-848-30 30 capsule, extended release in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Venlafaxine Hydrochloride?

Major Depressive DisorderVenlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder.The efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.The efficacy of venlafaxine hydrochloride tablets (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of venlafaxine hydrochloride extended-release capsules in hospitalized depressed patients have not been adequately studied. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride extended-release tablets (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Generalized Anxiety DisorderVenlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.The efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria (see Clinical Trials). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance.Although the effectiveness of venlafaxine hydrochloride extended-release capsules have been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety DisorderVenlafaxine hydrochloride extended-release capsules is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23).Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.The efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV) (see Clinical Trials). Although the effectiveness of venlafaxine hydrochloride extended-release capsules have been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic DisorderVenlafaxine hydrochloride extended-release capsules are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, i.e., a discrete period of intense fear or discomfort, in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) derealization (feelings of unreality) or depersonalization (being detached from oneself); 10) fear of losing control; 11) fear of dying; 12) paresthesias (numbness or tingling sensations); 13) chills or hot flushes.The efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of venlafaxine hydrochloride extended-release capsules in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Which are Venlafaxine Hydrochloride UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Venlafaxine Hydrochloride Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Venlafaxine Hydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 313581 - venlafaxine HCl 150 MG 24HR Extended Release Oral Capsule
  • RxCUI: 313581 - 24 HR venlafaxine 150 MG Extended Release Oral Capsule
  • RxCUI: 313581 - venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 313583 - venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule
  • RxCUI: 313583 - 24 HR venlafaxine 37.5 MG Extended Release Oral Capsule

* Please review the disclaimer below.

Patient Education

Venlafaxine


Venlafaxine is used to treat depression. Venlafaxine extended-release (long-acting) capsules are also used to treat generalized anxiety disorder (GAD; excessive worrying that is difficult to control), social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life), and panic disorder (sudden, unexpected attacks of extreme fear and worry about these attacks). Venlafaxine 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.
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Antidepressants


What are antidepressants?

Antidepressants are prescription medicines to treat depression. Depression is more than feeling a little sad or "blue" for a few days. It's a very common, serious medical illness that affects your mood and general mental health It can make you feel tired, hopeless, worried, or fearful. It can change your thinking, sleeping, and eating. Depression may make some people think about ending their lives.

But antidepressants can help many people who have depression. Researchers think antidepressants may help improve the way your brain uses certain chemicals that control mood or stress.

Are antidepressants used for other conditions?

A health care provider may prescribe antidepressants for anxiety, chronic pain, or insomnia. Sometimes providers also prescribe antidepressants for other conditions.

What are the different types of antidepressants?

There are many types of antidepressants. Each one works differently. Providers usually prescribe newer antidepressants first because they don't cause as many side effects as older types. They also seem to help more kinds of depression and anxiety problems.

Most of the newer antidepressants belong to one of these three groups:

  • Selective serotonin reuptake inhibitors (SSRIs)
  • Serotonin and norepinephrine reuptake inhibitors (SNRIs)
  • Atypical antidepressants, which are newer antidepressants that don't fit into the other groups

If these antidepressants don't help, your provider might suggest one of the older antidepressants. The older types include tricyclic antidepressants (TCAs), tetracyclics, and monoamine oxidase inhibitors (MAOIs). Even though these antidepressants may cause more serious side effects, the benefits may outweigh the risks for some people.

Which type of antidepressant is right for me?

Our bodies and brains all work differently. That means one antidepressant won't work for everyone. You may need to try two or more medicines before you find one that works for you.

Your provider will work with you to choose the best option to try first. You'll consider questions such as:

  • Which symptoms bother you most? Some antidepressants may do a better job helping specific symptoms, such as trouble sleeping.
  • What other medicines and supplements do you take? Some antidepressants can cause problems if you take them with certain medicines and herbs.
  • Did a certain antidepressant work well for a close relative? An antidepressant that helped a parent, brother, or sister could be a good choice for you, too.
  • Do you have other health conditions? Certain antidepressants can make some other conditions better or worse. Any other conditions that you have will be part of choosing your depression treatment.
  • Are you pregnant, planning for pregnancy, or breastfeeding? If so, your provider will help you find a way to treat your depression that's safe for you and your baby.

How long do antidepressants take to work?

Antidepressants usually take 4 to 8 weeks to work, so you'll need to be patient. You may notice that some problems, such as sleeping and eating, get better before your mood improves. That's a good sign. You may just need to give the medicine a little more time to do its job.

Sometimes an antidepressant helps at first, but symptoms return while you're still taking it. But there's usually another one you can try. To get more relief from depression, your provider may suggest combining two antidepressants, using another kind of medicine with an antidepressant, or adding talk therapy or other approaches to improve your mental health.

How long will I need to take an antidepressant?

When an antidepressant starts to work, you and your provider can decide how long you need to stay on it. The typical length of treatment is 6 to 12 months, but some people may stay on antidepressants for much longer.

What are the side effects of antidepressants?

Not everyone has side effects from antidepressants. But if you do have them, they're usually mild and may get better over time as your body gets used to the new medicine.

The most common side effects from antidepressants include:

When thinking about side effects, it's important to remember that there are also risks from not treating depression. Your provider can help you think through the pros and cons of all your options.

If you have any side effects from antidepressants, your provider may suggest ways to manage them while you wait to see if the antidepressant will work. If the side effects bother you too much, you may need to change antidepressants. But you should never change your dose or stop taking an antidepressant on your own.

If you have serious problems or notice any changes that worry you, such as new or worsening symptoms, unusual changes in your mood, or you start acting differently, call your provider right away.

In some cases, children, teenagers, and young adults under 25 may be more likely to think about hurting or killing themselves when starting antidepressants or when the dose is changed. Get medical help right away if this happens.

What can I do to take antidepressants safely?

Antidepressants are generally safe when you use them correctly:

  • Tell your provider about everything you take. That includes medicines, herbs, supplements, and over-the-counter medicines you take, such as pain relievers and decongestants. Be honest about recreational drugs and alcohol, too.
  • Try to get all your medicines from the same pharmacy. That way the pharmacist can warn you and your provider if you take medicines that may cause problems when used together.
  • Follow all instructions about how to take your medicine.
  • Talk with your provider if side effects bother you.
  • Never stop taking antidepressants without your provider's help. Stopping too fast may make depression come back. You could even make your condition worse. To stop antidepressants safely, you need to give your body time to get used to being without the medicine. Your provider can tell you the safest way to go off an antidepressant.

NIH: National Institute of Mental Health


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* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".