NDC 59011-522 Targiniq 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:
59011-522
Proprietary Name:
Targiniq ER
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Purdue Pharma Lp
Labeler Code:
59011
Start Marketing Date: [9]
01-01-2020
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
WHITE (C48325)
YELLOW (C48330)
Shape:
CAPSULE (C48336)
Size(s):
10 MM
5 MM
14 MM
Imprint(s):
ONX;20
ONX;10
ONX;40
Score:
1

Product Packages

NDC Code 59011-522-01

Package Description: 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Product Details

What is NDC 59011-522?

The NDC code 59011-522 is assigned by the FDA to the product Targiniq ER which is product labeled by Purdue Pharma Lp. The product's dosage form is . The product is distributed in a single package with assigned NDC code 59011-522-01 100 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 Targiniq ER?

TARGINIQ ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve TARGINIQ ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.TARGINIQ ER is not indicated as an as-needed (prn) analgesic.The maximum total daily dose of TARGINIQ ER should not exceed 80 mg/40 mg (40 mg/20 mg q12h) because higher doses may be associated with symptoms of opioid withdrawal or decreased analgesia [see Warnings and Precautions 5.12].

Which are Targiniq ER UNII Codes?

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

Which are Targiniq 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 Targiniq 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:
  • RxCUI: 1545903 - 12 HR naloxone hydrochloride 10 MG / oxycodone hydrochloride 20 MG Extended Release Oral Tablet
  • RxCUI: 1545903 - oxycodone HCl 20 MG / naloxone HCl 10 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1545907 - 12 HR naloxone hydrochloride 20 MG / oxycodone hydrochloride 40 MG Extended Release Oral Tablet
  • RxCUI: 1545907 - oxycodone HCl 40 MG / naloxone HCl 20 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1545910 - 12 HR naloxone hydrochloride 5 MG / oxycodone hydrochloride 10 MG Extended Release Oral Tablet

* 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".