Avinza
NDC Package 16590-593-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Avinza is 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. Marketed by Stat Rx Usa Llc, this product is identified by NDC 16590-593 and is authorized under FDA application NDA021260.

Identification & Billing

NDC Package Code
16590-593-30
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
16590-593
11-Digit Billing Format
16590059330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Avinza
Dosage Form
-
Usage Information
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)

Regulatory & Marketing

Labeler Name
Stat Rx Usa Llc
FDA Application #
NDA021260
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-20-2002
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (16590-593). Click a package code to view its specific billing and regulatory data.

16590-593-60
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
16590-593-90
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 16590-593-30 identifies a specific commercial package of 30 capsule, extended release in 1 bottle of Avinza, labeled by Stat Rx Usa Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Stat Rx Usa Llc on March 20, 2002. The current certification is valid through December 31, 2017.

How is this Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590059330. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
16590-593-30
11-Digit CMS (5-4-2)
16590-0593-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.