Kadian
NDC Package 54868-4572-2

11-digit billing NDC: 54868457202 · Billing unit: EA · 20 EA per package
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.

Kadian is ® Capsules are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (see CLINICAL PHARMACOLOGY).KADIAN® Capsules are NOT intended for use as a prn analgesic.KADIAN® is not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild or not expected to persist for an extended period of time. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4572 and is authorized under FDA application NDA020616.

Identification & Billing

NDC Package Code
54868-4572-2
Package Description
20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
54868-4572
11-Digit Billing Format
54868457202
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
20 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kadian
Dosage Form
-
Usage Information
KADIAN® Capsules are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (see CLINICAL PHARMACOLOGY).KADIAN® Capsules are NOT intended for use as a prn analgesic.KADIAN® is not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild or not expected to persist for an extended period of time. KADIAN® is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA020616
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-07-2001
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 (54868-4572). Click a package code to view its specific billing and regulatory data.

54868-4572-0
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
54868-4572-1
30 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 54868-4572-2 identifies a specific commercial package of 20 capsule, extended release in 1 bottle of Kadian, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 20 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 Physicians Total Care, Inc. on November 07, 2001. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868457202. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 20 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 (5-4-1)
54868-4572-2
11-Digit CMS (5-4-2)
54868-4572-02

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