Morphine Sulfate Injection, Solution
NDC Package 76045-005-12

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 injection is a medication used to treat severe pain. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi, Usa Llc, this product is identified by NDC 76045-005 and is authorized under FDA application NDA204223.

Identification & Billing

NDC Package Code
76045-005-12
Package Description
24 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-005-02) / 1 mL in 1 SYRINGE, GLASS
Product Code
76045-005
11-Digit Billing Format
76045000512

Clinical Specifications

Proprietary Name
Morphine Sulfate
Non-Proprietary Name
Morphine Sulfate
Substance Name
Morphine Sulfate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MORPHINE SULFATE 4 mg/mL
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
Fresenius Kabi, Usa Llc
Product Type
Human Prescription Drug
FDA Application #
NDA204223
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-30-2013
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76045-005). Click a package code to view its specific billing and regulatory data.

76045-005-11
10 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS (76045-005-01)

* 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 76045-005-12 identifies a specific commercial package of 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack (76045-005-02) / 1 ml in 1 syringe, glass of Morphine Sulfate, a human prescription drug labeled by Fresenius Kabi, Usa Llc. This injection, solution is formulated for intramuscular; intravenous 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 Fresenius Kabi, Usa Llc on October 30, 2013. The current certification is valid through December 31, 2026.

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 Fresenius Kabi, Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76045000512. 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)
76045-005-12
11-Digit CMS (5-4-2)
76045-0005-12

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