NDC 50090-4716 Tramadol Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
50090-4716
Proprietary Name:
Tramadol Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
A-s Medication Solutions
Labeler Code:
50090
Start Marketing Date: [9]
05-22-2015
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
10 MM
Imprint(s):
101;OUYI
Score:
1

Product Packages

NDC Code 50090-4716-0

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC Code 50090-4716-1

Package Description: 20 TABLET, FILM COATED in 1 BOTTLE

NDC Code 50090-4716-2

Package Description: 50 TABLET, FILM COATED in 1 BOTTLE

NDC Code 50090-4716-3

Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

NDC Code 50090-4716-4

Package Description: 15 TABLET, FILM COATED in 1 BOTTLE

NDC Code 50090-4716-5

Package Description: 60 TABLET, FILM COATED in 1 BOTTLE

NDC Code 50090-4716-9

Package Description: 120 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 50090-4716?

The NDC code 50090-4716 is assigned by the FDA to the product Tramadol Hydrochloride which is product labeled by A-s Medication Solutions. The product's dosage form is . The product is distributed in 7 packages with assigned NDC codes 50090-4716-0 30 tablet, film coated in 1 bottle , 50090-4716-1 20 tablet, film coated in 1 bottle , 50090-4716-2 50 tablet, film coated in 1 bottle , 50090-4716-3 100 tablet, film coated in 1 bottle , 50090-4716-4 15 tablet, film coated in 1 bottle , 50090-4716-5 60 tablet, film coated in 1 bottle , 50090-4716-9 120 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 Tramadol Hydrochloride?

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, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:•Have not been tolerated or are not expected to be tolerated.•Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Which are Tramadol Hydrochloride UNII Codes?

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

Which are Tramadol Hydrochloride 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 Tramadol Hydrochloride?

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:

* Please review the disclaimer below.

Patient Education

Tramadol


Tramadol is used to relieve moderate to moderately severe pain. Tramadol extended-release tablets and capsules are only used by people who are expected to need medication to relieve pain around-the-clock. 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.
[Learn More]


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.


[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.

[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".