Famotidine Tablet, Film Coated
NDC 31722-017

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 31722-017?
  5. Famotidine Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Famotidine is a ANDA-approved product labeled by Camber Pharmaceuticals, Inc.. Famotidine is used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. It is supplied as a yellow tablet, film coated for oral administration. This product entry covers the primary NDC 31722-017 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
31722-017
Proprietary Name:
Famotidine
Non-Proprietary Name: [1]
Famotidine
Substance Name: [2]
Famotidine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Camber Pharmaceuticals, Inc.
Labeler Code:
31722
Product Label ID:
902b5d4b-1707-4312-9f46-ef5ab86b00f0
FDA Application Number: [6]
ANDA215767
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-04-2021
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
YELLOW (C48330 - LIGHT YELLOW)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
T;11
Score:
1

Code Structure Chart

Product Details

What is NDC 31722-017?

The NDC code 31722-017 is assigned by the FDA to the product Famotidine. This pharmaceutical product is labeled by Camber Pharmaceuticals, Inc. and is currently categorized as listed product. The medication is a tablet, film coated administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 31722-017-01, 31722-017-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Famotidine is used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Famotidine belongs to a class of drugs known as H2 blockers. This medication is also available without a prescription. It is used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion). If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist.

What are Active Ingredients of this product?

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.
  • FAMOTIDINE 20 mg/1 - A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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 of this product?

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 full disclaimer at the bottom of this page.

Patient Education

Duloxetine


Duloxetine is used to treat depression in adults and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life and lasts for 6 months or longer) in adults and children 7 years of age and older. Duloxetine is also used to treat pain and tingling caused by diabetic neuropathy (damage to nerves that can develop in people who have diabetes) in adults and fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep) in adults and children 13 years of age and older. It is also used to treat ongoing bone or muscle pain such as lower back pain or osteoarthritis (joint pain or stiffness that may worsen over time) in adults. Duloxetine 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 and stop the movement of pain signals in the brain.
[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]


Famotidine


Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube that connects the mouth and stomach]); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas or small intestine that cause increased production of stomach acid). Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".