NDC 0049-4960 Zoloft

Sertraline Hydrochloride Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0049-4960
Proprietary Name:
Zoloft
Non-Proprietary Name: [1]
Sertraline Hydrochloride
Substance Name: [2]
Sertraline Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Roerig
    Labeler Code:
    0049
    FDA Application Number: [6]
    NDA019839
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    02-11-1992
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    GREEN (C48329 - LIGHT GREEN)
    Shape:
    OVAL (C48345)
    Size(s):
    8 MM
    Imprint(s):
    ZOLOFT;25;MG
    Score:
    2

    Product Packages

    NDC Code 0049-4960-30

    Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $11.93070 per EA

    Product Details

    What is NDC 0049-4960?

    The NDC code 0049-4960 is assigned by the FDA to the product Zoloft which is a human prescription drug product labeled by Roerig. The generic name of Zoloft is sertraline hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 0049-4960-30 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 Zoloft?

    Sertraline is used to treat depression, panic attacks, obsessive compulsive disorder, post-traumatic stress disorder, social anxiety disorder (social phobia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. It may also reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, and checking) that interfere with daily living. Sertraline is known as a selective serotonin reuptake inhibitor (SSRI). It works by helping to restore the balance of a certain natural substance (serotonin) in the brain.

    What are Zoloft Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Zoloft UNII Codes?

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

    Which are Zoloft 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 Zoloft?

    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:

    Which are the Pharmacologic Classes for Zoloft?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Sertraline


    Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). It is also used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness. Sertraline is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amounts of serotonin, a natural substance in the brain that helps maintain mental balance.
    [Learn More]


    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

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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.

    [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".