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  4. NDC Product Code: 16590-597 Avinza

NDC 16590-597 Avinza

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 16590-597?
  5. Avinza Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. 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:
16590-597
Proprietary Name:
Avinza
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Stat Rx Usa Llc
Labeler Code:
16590
Product Label ID:
59007321-a6e4-4c98-858e-e824921f6a35
Start Marketing Date: [9]
03-20-2002
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
WHITE (C48325)
GREEN (C48329 - BLUISH-GREEN)
BLUE (C48333 - BLUISH-GREEN)
RED (C48326)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
19 MM
Imprint(s):
AVINZA;30;MG;505
AVINZA;60;MG;506
AVINZA;90;MG;507
Score:
1

Product Packages

NDC Code 16590-597-30

Package Description: 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

NDC Code 16590-597-60

Package Description: 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

NDC Code 16590-597-90

Package Description: 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Product Details

What is NDC 16590-597?

The NDC code 16590-597 is assigned by the FDA to the product Avinza 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 16590-597-30 30 capsule, extended release in 1 bottle , 16590-597-60 60 capsule, extended release in 1 bottle , 16590-597-90 90 capsule, 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 Avinza?

AVINZA capsules are a modified-release formulation of morphine sulfate intended for once daily administration indicated for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time.AVINZA is NOT intended for use as a prn analgesic.The safety and efficacy of using AVINZA in the postoperative setting has not been evaluated. AVINZA is not indicated for postoperative use. If the patient has been receiving the drug prior to surgery, resumption of the pre-surgical dose may be appropriate once the patient is able to take the drug by mouth. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (see American Pain Society guidelines)

Which are Avinza UNII Codes?

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

Which are Avinza 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 Avinza?

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: 892342 - morphine sulfate 30 MG 24HR Extended Release Oral Capsule
  • RxCUI: 892342 - 24 HR morphine sulfate 30 MG Extended Release Oral Capsule
  • RxCUI: 892342 - 24 HR MS 30 MG Extended Release Oral Capsule
  • RxCUI: 892342 - morphine sulfate 30 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 892344 - Avinza 30 MG 24HR Extended Release Oral Capsule

* 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".