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  4. NDC Product Code: 68071-4379 Mirtazapine

NDC 68071-4379 Mirtazapine

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68071-4379?
  5. Mirtazapine Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
68071-4379
Proprietary Name:
Mirtazapine
Product Type: [3]
Labeler Name: [5]
Nucare Pharmaceuticals,inc.
Labeler Code:
68071
Product Label ID:
6932069e-b1cb-0777-e053-2a91aa0a4a2b
FDA Application Number: [6]
ANDA076921
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
08-17-2009
End Marketing Date: [10]
12-31-2020
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - YELLOW)
Shape:
CAPSULE (C48336)
Size(s):
9 MM
Imprint(s):
0;8;A
Score:
2

Code Structure Chart

Product Details

What is NDC 68071-4379?

The NDC code 68071-4379 is assigned by the FDA to the product Mirtazapine which is product labeled by Nucare Pharmaceuticals,inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68071-4379-3 30 tablet, film coated 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 Mirtazapine?

Mirtazapine is used to treat depression. It improves mood and feelings of well-being. Mirtazapine is an antidepressant that works by restoring the balance of natural chemicals (neurotransmitters) in the brain.

Which are Mirtazapine UNII Codes?

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

Which are Mirtazapine 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:

* Please review the disclaimer below.

Patient Education

Mirtazapine


Mirtazapine is used to treat depression. Mirtazapine is in a class of medications called antidepressants. It works by increasing certain types of activity in the brain to 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


[Learn More]


* 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.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".