NDC 55700-797 Nucynta ER

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:
55700-797
Proprietary Name:
Nucynta ER
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Quality Care Products, Llc
Labeler Code:
55700
Start Marketing Date: [9]
09-27-2019
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
BLUE (C48333 - LIGHT BLUE)
Shape:
OVAL (C48345)
Size(s):
17 MM
Imprint(s):
OMJ;50
OMJ;100
Score:
1

Product Packages

NDC Code 55700-797-60

Package Description: 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Product Details

What is NDC 55700-797?

The NDC code 55700-797 is assigned by the FDA to the product Nucynta ER which is product labeled by Quality Care Products, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 55700-797-60 60 tablet, film coated, extended release 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 Nucynta ER?

Tapentadol is used to help relieve moderate to severe short-term pain (such as pain from an injury or after surgery). It 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.

Which are Nucynta ER UNII Codes?

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

Which are Nucynta ER 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 Nucynta ER?

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

Tapentadol


Tapentadol tablets are used to treat moderate to 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). Tapentadol extended-release tablets are used to treat severe neuropathic pain (pain caused by nerve damage) in people who have diabetes. Tapentadol extended-release tablets are only used to treat people who are expected to need medication around-the-clock to relieve pain that cannot be controlled by the use of other pain medications. 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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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".