Morphine Sulfate
NDC Package 35356-521-60

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 discontinued by the firm.

Morphine Sulfate is a medication used to treat severe pain. Marketed by Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc, this product is identified by NDC 35356-521 and is authorized under FDA application ANDA076438.

Identification & Billing

NDC Package Code
35356-521-60
Package Description
60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
35356-521
11-Digit Billing Format
35356052160
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

Clinical Specifications

Proprietary Name
Morphine Sulfate Extended-release
Dosage Form
-
Usage Information
This medication is used to treat severe pain. Morphine belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain.

Regulatory & Marketing

Labeler Name
Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc
FDA Application #
ANDA076438
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-28-2011
End Marketing Date
01-04-2018
Listing Expiration
01-04-2018
Exclude Flag
D
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 (35356-521). Click a package code to view its specific billing and regulatory data.

35356-521-30
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

* 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 35356-521-60 identifies a specific commercial package of 60 tablet, extended release in 1 bottle, plastic of Morphine Sulfate Extended-release, labeled by Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 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 Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc on July 28, 2011. The current certification is valid through January 04, 2018.

What are the primary indications for this medication?

This medication is used to treat severe pain. Morphine belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain.

How is this Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35356052160. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
35356-521-60
11-Digit CMS (5-4-2)
35356-0521-60

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