Morphine Sulfate Tablet, Film Coated, Extended Release
NDC Package 63304-451-01

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

Morphine Sulfate tablets is a medication used to treat severe pain. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 63304-451 and is authorized under FDA application ANDA078761.

Identification & Billing

NDC Package Code
63304-451-01
Package Description
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
63304-451
11-Digit Billing Format
63304045101
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, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MORPHINE SULFATE 30 mg/1
Pharmacologic Class
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.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078761
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-11-2012
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 (63304-451). Click a package code to view its specific billing and regulatory data.

63304-451-03
10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
63304-451-05
500 TABLET, FILM COATED, 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 63304-451-01 identifies a specific commercial package of 100 tablet, film coated, extended release in 1 bottle of Morphine Sulfate, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This tablet, film coated, 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 Sun Pharmaceutical Industries, Inc. on May 11, 2012. The current certification is valid through December 31, 2027.

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 Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304045101. 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 (5-3-2)
63304-451-01
11-Digit CMS (5-4-2)
63304-0451-01

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