Morphine Sulfate Tablet, Extended Release
NDC Package 0406-8315-62

11-digit billing NDC: 00406831562 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Morphine Sulfate tablets is morphine sulfate extended-release tablets 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.Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including morphine sulfate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. This formulation utilizes a tablet, extended release delivery system. Marketed by Specgx Llc, this product is identified by NDC 0406-8315 and is authorized under FDA application ANDA076412.

Identification & Billing

NDC Package Code
0406-8315-62
Package Description
100 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
0406-8315
11-Digit Billing Format
00406831562
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Morphine Sulfate
Non-Proprietary Name
Morphine Sulfate
Substance Name
Morphine Sulfate
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MORPHINE SULFATE 15 mg/1
Pharmacologic Class
Usage Information
Morphine sulfate extended-release tablets 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.Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including morphine sulfate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Specgx Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA076412
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-31-2003
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0406-8315). Click a package code to view its specific billing and regulatory data.

0406-8315-01
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
0406-8315-23
1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

* 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 0406-8315-62 identifies a specific commercial package of 100 tablet, extended release in 1 blister pack of Morphine Sulfate, a human prescription drug labeled by Specgx Llc. This tablet, 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 Specgx Llc on July 31, 2003. The current certification is valid through December 31, 2027.

How is this Specgx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00406831562. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (4-4-2)
0406-8315-62
11-Digit CMS (5-4-2)
00406-8315-62

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