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  4. NDC Product Code: 16590-897 Embeda

NDC 16590-897 Embeda

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 16590-897?
  5. Embeda Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
16590-897
Proprietary Name:
Embeda
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Stat Rx Usa Llc
Labeler Code:
16590
Product Label ID:
dfe97a3d-247d-4dda-a641-1a95196cd8d8
Start Marketing Date: [9]
08-13-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
Shape:
CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
EMBEDA;20
Score:
1

Product Packages

NDC Code 16590-897-30

Package Description: 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Code 16590-897-60

Package Description: 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Code 16590-897-90

Package Description: 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Product Details

What is NDC 16590-897?

The NDC code 16590-897 is assigned by the FDA to the product Embeda which is product labeled by Stat Rx Usa Llc. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 16590-897-30 30 capsule, extended release in 1 bottle, plastic , 16590-897-60 60 capsule, extended release in 1 bottle, plastic , 16590-897-90 90 capsule, extended release in 1 bottle, plastic . 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 Embeda?

This medication contains morphine in a long-acting form and naltrexone. It is used to help relieve severe long-term pain (usually lasting longer than a few days). Morphine 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. Naltrexone belongs to a class of drugs known as opioid antagonists. It is combined with morphine to prevent crushing/dissolving the medication for abuse/misuse. The highest strength of this drug (100 milligrams per capsule) should be used only if you have been regularly taking moderate to large amounts of opioid pain medication. This strength may cause overdose (even death) if taken by a person who has not been regularly taking opioids. Do not use the extended-release form of morphine to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

Which are Embeda UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Embeda?

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: 863848 - morphine sulfate 20 MG / naltrexone HCl 0.8 MG Extended Release Oral Capsule, Abuse-Deterrent
  • RxCUI: 863848 - Abuse-Deterrent morphine sulfate 20 MG / naltrexone hydrochloride 0.8 MG Extended Release Oral Capsule
  • RxCUI: 863848 - Abuse-Deterrent MS 20 MG / Naltrexone hydrochloride 0.8 MG Extended Release Oral Capsule
  • RxCUI: 863849 - EMBEDA 20 MG / 0.8 MG Extended Release Oral Capsule
  • RxCUI: 863849 - Abuse-Deterrent morphine sulfate 20 MG / naltrexone hydrochloride 0.8 MG Extended Release Oral Capsule [Embeda]

* 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".