NDC 20482-001 Subsys

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:
20482-001
Proprietary Name:
Subsys
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Insys Therapeutics, Inc.
Labeler Code:
20482
Start Marketing Date: [9]
03-13-2012
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Packages

NDC Code 20482-001-10

Package Description: 10 BLISTER PACK in 1 CARTON / 1 BOTTLE, SPRAY in 1 BLISTER PACK / 1 SPRAY in 1 BOTTLE, SPRAY

NDC Code 20482-001-30

Package Description: 30 BLISTER PACK in 1 CARTON / 1 BOTTLE, SPRAY in 1 BLISTER PACK / 1 SPRAY in 1 BOTTLE, SPRAY

Product Details

What is NDC 20482-001?

The NDC code 20482-001 is assigned by the FDA to the product Subsys which is product labeled by Insys Therapeutics, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 20482-001-10 10 blister pack in 1 carton / 1 bottle, spray in 1 blister pack / 1 spray in 1 bottle, spray, 20482-001-30 30 blister pack in 1 carton / 1 bottle, spray in 1 blister pack / 1 spray in 1 bottle, spray. 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 Subsys?

See also Warning section. This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of opioid pain medication. Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

Which are Subsys UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Subsys?

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

Fentanyl Sublingual Spray


Fentanyl sublingual spray is used to treat breakthrough pain (sudden episodes of pain that occur despite round the clock treatment with pain medication) in cancer patients 18 years of age and older who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. Fentanyl is in a class of medications called narcotic (opiate) 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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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".