NDC 16590-747 Opana 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:
16590-747
Proprietary Name:
Opana ER
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Stat Rx Usa Llc
Labeler Code:
16590
Start Marketing Date: [9]
06-22-2006
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
ORANGE (C48331)
Shape:
OCTAGON (8 SIDED) (C48344)
Size(s):
8 MM
Imprint(s):
E907;5
E674;10
Score:
2

Product Packages

NDC Code 16590-747-30

Package Description: 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

NDC Code 16590-747-56

Package Description: 56 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

NDC Code 16590-747-60

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

NDC Code 16590-747-90

Package Description: 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Product Details

What is NDC 16590-747?

The NDC code 16590-747 is assigned by the FDA to the product Opana ER which is product labeled by Stat Rx Usa Llc. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 16590-747-30 30 tablet, film coated, extended release in 1 bottle , 16590-747-56 56 tablet, film coated, extended release in 1 bottle , 16590-747-60 60 tablet, film coated, extended release in 1 bottle , 16590-747-90 90 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 Opana ER?

Oxymorphone is used to help relieve moderate to severe pain. 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 Opana ER UNII Codes?

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

Which are Opana 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 Opana 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: 977874 - oxyMORphone HCl 10 MG 12HR Extended Release Oral Tablet
  • RxCUI: 977874 - 12 HR oxymorphone hydrochloride 10 MG Extended Release Oral Tablet
  • RxCUI: 977874 - oxymorphone hydrochloride 10 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 977876 - OPANA ER 10 MG 12HR Extended Release Oral Tablet
  • RxCUI: 977876 - 12 HR oxymorphone hydrochloride 10 MG Extended Release Oral Tablet [Opana]

* 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".