Sulbactam For Injection Injection, Powder, For Solution
NDC Package 22607-311-20

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Sulbactam For Injection injection is a human prescription drug. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Mitim S.r.l., this product is identified by NDC 22607-311.

Identification & Billing

NDC Package Code
22607-311-20
Package Description
96 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code
22607-311
11-Digit Billing Format
22607031120

Clinical Specifications

Proprietary Name
Sulbactam For Injection
Non-Proprietary Name
Sulbactam For Injection
Substance Name
Sulbactam Sodium
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Active Ingredient(s)
SULBACTAM SODIUM 1 g/5mL

Regulatory & Marketing

Labeler Name
Mitim S.r.l.
Product Type
Human Prescription Drug
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
06-06-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 22607-311-20 identifies a specific commercial package of 96 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose of Sulbactam For Injection (UNFINISHED drug), a human prescription drug labeled by Mitim S.r.l.. This injection, powder, for solution is formulated for use and contains sulbactam sodium 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 Mitim S.r.l. on June 06, 2023. The current certification is valid through December 31, 2026.

How is this Mitim S.r.l. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 22607031120. 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)
22607-311-20
11-Digit CMS (5-4-2)
22607-0311-20

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