Morphine Sulfate
NDC Package 0409-1134-03

11-digit billing NDC: 00409113403 · Billing unit: ML · 20 ML per package

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Morphine Sulfate is indicated for the relief of severe pain. Marketed by Hospira, Inc., this product is identified by NDC 0409-1134.

Identification & Billing

NDC Package Code
0409-1134-03
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE
Product Code
11-Digit Billing Format
00409113403
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
20 ML

Clinical Specifications

Proprietary Name
Morphine Sulfate
Dosage Form
-
Usage Information
Morphine sulfate is indicated for the relief of severe pain. It is used preoperatively to sedate the patient and allay apprehension, facilitate anesthesia induction and reduce anesthetic dosage. It is likewise effective in the control of post-operative pain.The use of morphine for the relief of pain should be reserved for the more severe manifestations of pain, as in myocardial infarction, severe injuries, or in severe chronic pain associated with terminal cancer after all non-narcotic analgesics have failed.Effective analgesic therapy of severe chronic pain associated with terminal cancer continues to be a difficult problem. Intermittent administration of intramuscular morphine may be effective; however, the mode of therapy has significant limitations. Morphine has a short plasma half-life of 2.5 to 3.0 hours; therefore, frequent administration (every 1 to 2 hours) often becomes necessary to control severe pain associated with cancer. Tolerance develops to the analgesic effects and increasingly higher doses of morphine are required to produce analgesia. The higher morphine doses produce significant and often life-threatening side effects (see ADVERSE REACTIONS). The peak and trough effects produced by intermittent administration cause fluctuations in pain control. Repeated intramuscular injections are frequently unacceptable due to the lack of muscle mass in the debilitated patient, the tendency for bruising and bleeding at the injection site, and the anxiety and pain associated with the injection.Continuous intravenous infusion of morphine (see DOSAGE AND ADMINISTRATION) has been employed as an alternative to traditional modes of administration. Lower doses of morphine produce uniform pain control because a steady morphine concentration is maintained. Titration of the dosage to the patient's needs is easily achieved by adjusting the infusion rate. The lag time between the patient's request for pain medication and administration of the dose and the amount of nursing time necessary for preparation and administration of frequent doses are reduced. The degree of respiratory depression and sedation may be decreased, and the anxiety experienced by the patient in anticipation of intramuscular administration is avoided. Some Investigators feel that tolerance to the analgesic effects may develop more slowly with continuous intravenous infusion.In addition to analgesia, the drug may relieve anxiety and reduce left ventricular work by reducing preload pressure. Morphine is also used in the therapy of dyspnea associated with acute left ventricular and pulmonary edema. Care must be taken to avoid inducing respiratory depression in such patients.For open-heart surgery, especially in high risk patients with cardiac disease, some anesthesiologists use morphine to produce anesthesia.

Regulatory & Marketing

Labeler Name
Hospira, Inc.
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
08-11-2005
End Marketing Date
09-01-2023
Listing Expiration
09-01-2023
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.

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Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

Source: ASP
Morphine sulfate injection
HCPCS Dosage 10 MG
Units / Pkg 100

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (0409-1134). Click a package code to view its specific billing and regulatory data.

1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0409-1134-03 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose of Morphine Sulfate, labeled by Hospira, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 20 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 Hospira, Inc. on August 11, 2005. The current certification is valid through September 01, 2023.

How is this Hospira, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00409113403. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 20 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)
0409-1134-03
11-Digit CMS (5-4-2)
00409-1134-03

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