Morphine Sulfate Suppository
NDC Package 0574-7110-12

11-digit billing NDC: 00574711012 · Billing unit: EA · 12 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Morphine Sulfate suppositories are indicated for the management of acute and chronic pain severe enough to require and opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve morphine sulfate suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:•Have not been tolerated, or are not expected to be tolerated,•Have not provided adequate analgesia, or are not expected to provide adequate analgesia. This formulation utilizes a suppository delivery system. Marketed by Padagis Us Llc, this product is identified by NDC 0574-7110.

Identification & Billing

NDC Package Code
0574-7110-12
Package Description
12 PACKET in 1 BOX / 1 SUPPOSITORY in 1 PACKET
Product Code
0574-7110
11-Digit Billing Format
00574711012
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
12 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Morphine Sulfate
Non-Proprietary Name
Morphine Sulfate
Substance Name
Morphine Sulfate
Dosage Form
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
MORPHINE SULFATE 5 mg/1
Pharmacologic Class
Usage Information
Morphine sulfate suppositories are indicated for the management of acute and chronic pain severe enough to require and opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve morphine sulfate suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:•Have not been tolerated, or are not expected to be tolerated,•Have not provided adequate analgesia, or are not expected to provide adequate analgesia
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Padagis Us Llc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
09-01-1990
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 0574-7110-12 identifies a specific commercial package of 12 packet in 1 box / 1 suppository in 1 packet of Morphine Sulfate, a human prescription drug labeled by Padagis Us Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 12 billable units per package. This suppository is formulated for rectal 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 Padagis Us Llc on September 01, 1990. The current certification is valid through December 31, 2026.

How is this Padagis Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00574711012. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 12 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)
0574-7110-12
11-Digit CMS (5-4-2)
00574-7110-12

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