Tramadol Hydrochloride
NDC 67296-1919

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 67296-1919?
  5. Tramadol 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.

Tramadol Hydrochloride is a ANDA-approved product labeled by Redpharm Drug. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 67296-1919 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
67296-1919
Proprietary Name:
Tramadol Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Redpharm Drug
Labeler Code:
67296
Product Label ID:
1e0467c7-58de-9ccf-e063-6294a90aaed6
FDA Application Number: [6]
ANDA202075
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
03-01-2018
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
Shape:
CAPSULE (C48336)
Size(s):
8 MM
Imprint(s):
ET50
Score:
1

Code Structure Chart

Product Details

What is NDC 67296-1919?

The NDC code 67296-1919 is assigned by the FDA to the product Tramadol Hydrochloride. This pharmaceutical product is labeled by Redpharm Drug and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 67296-1919-1. 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?

Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.1), reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products):  Have not been tolerated, or are not expected to be tolerated, (1) Have not provided adequate analgesia, or are not expected to provide adequate analgesia (1)Tramadol hydrochloride tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

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:

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Patient Education

Tramadol


Tramadol immediate-release tablets and oral solution are used as a short-term treatment to relieve severe pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) in people who are expected to need an opioid pain medication and who cannot be controlled by the use of alternative pain medications. Tramadol extended-release tablets and capsules are used to relieve severe and persistent pain in people who are expected to need an opioid pain medication to relieve pain around-the-clock for a long time and who cannot be treated with other pain medications. Tramadol extended-release tablets and capsules should not be used to treat mild or moderate pain, short-term pain, or pain that can be controlled by medication that is taken as needed. Tramadol 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 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".