Nucynta
NDC 35356-525

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 35356-525?
  4. Nucynta Uses
  5. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Nucynta is a NDA-approved product labeled by Lake Erie Medical Dba Quality Care Products Llc. Tapentadol is used to help relieve moderate to severe short-term pain (such as pain from an injury or after surgery). It is supplied as a product. This product entry covers the primary NDC 35356-525 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
35356-525
Proprietary Name:
Nucynta
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Lake Erie Medical Dba Quality Care Products Llc
Labeler Code:
35356
FDA Application Number: [6]
NDA022304
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
09-29-2010
End Marketing Date: [10]
06-30-2019
Listing Expiration Date: [11]
06-30-2019
Exclude Flag: [12]
D

Code Structure Chart

Patient Education

Tapentadol


Tapentadol immediate-release tablets are used as short-term treatment to relieve severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) in adults and children 6 years of age and older who weigh at least 88 lb (40 kg) who are expected to need an opioid pain medication and whose pain cannot be controlled by the use of alternative pain medications. Tapentadol extended-release tablets are used to relieve severe and persistent (around-the-clock) pain that cannot be controlled by the use of other pain medications. Tapentadol extended-release tablets are also used to relieve severe and persistent (around-the-clock) neuropathic pain (pain caused by nerve damage) that cannot be controlled by the use of other pain medications.in people who have diabetes. Tapentadol extended-release tablets should not be used to treat pain that can be controlled by medication that is taken as needed. Tapentadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
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Pain Relievers


Pain relievers are medicines that reduce or relieve headaches, sore muscles, arthritis, or other aches and pains. There are many different pain medicines, and each one has advantages and risks. Some types of pain respond better to certain medicines than others. Each person may also have a slightly different response to a pain reliever.

Over-the-counter (OTC) medicines are good for many types of pain. There are two main types of OTC pain medicines: acetaminophen (Tylenol) and nonsteroidal anti-inflammatory drugs (NSAIDs). Aspirin, naproxen (Aleve), and ibuprofen (Advil, Motrin) are examples of OTC NSAIDs.

If OTC medicines don't relieve your pain, your doctor may prescribe something stronger. Many NSAIDs are also available at higher prescription doses. The most powerful pain relievers are opioids. They are very effective, but they can sometimes have serious side effects. There is also a risk of addiction. Because of the risks, you must use them only under a doctor's supervision.

There are many things you can do to help ease pain. Pain relievers are just one part of a pain treatment plan.


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

Product & Regulatory Definitions
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 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.
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".