Morphine Sulfate Capsule, Extended Release
NDC Package 42689-005-01

11-digit billing NDC: 42689000501
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Morphine Sulfate capsules is morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. This formulation utilizes a capsule, extended release delivery system. Marketed by Nortec Development Associates, Inc., this product is identified by NDC 42689-005 and is authorized under FDA application ANDA203158.

Identification & Billing

NDC Package Code
42689-005-01
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
42689-005
11-Digit Billing Format
42689000501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Morphine Sulfate
Non-Proprietary Name
Morphine Sulfate
Substance Name
Morphine Sulfate
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MORPHINE SULFATE 20 mg/1
Pharmacologic Class
Usage Information
Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Nortec Development Associates, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203158
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-07-2009
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42689-005-01 identifies a specific commercial package of 100 capsule, extended release in 1 bottle of Morphine Sulfate, a human prescription drug labeled by Nortec Development Associates, Inc.. This capsule, extended release is formulated for oral use and contains morphine sulfate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Nortec Development Associates, Inc. on April 07, 2009. The current certification is valid through December 31, 2026.

How is this Nortec Development Associates, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42689000501. 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)
42689-005-01
11-Digit CMS (5-4-2)
42689-0005-01

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