Ertapenem
NDC Package 67184-0551-2

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

Ertapenem is used to prevent and treat a wide variety of bacterial infections. Marketed by Qilu Pharmaceutical Co., Ltd., this product is identified by NDC 67184-0551 and is authorized under FDA application ANDA218067.

Identification & Billing

NDC Package Code
67184-0551-2
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (67184-0551-1)
Product Code
67184-0551
11-Digit Billing Format
67184055102

Clinical Specifications

Proprietary Name
Ertapenem
Dosage Form
-
Usage Information
Ertapenem is used to prevent and treat a wide variety of bacterial infections. This medication is known as a carbapenem-type antibiotic. It works by stopping the growth of bacteria.

Regulatory & Marketing

Labeler Name
Qilu Pharmaceutical Co., Ltd.
FDA Application #
ANDA218067
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-2024
End Marketing Date
11-14-2024
Listing Expiration
11-14-2024
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.

* 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 67184-0551-2 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose (67184-0551-1) of Ertapenem, labeled by Qilu Pharmaceutical Co., Ltd.. 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 Qilu Pharmaceutical Co., Ltd. on October 31, 2024. The current certification is valid through November 14, 2024.

What are the primary indications for this medication?

Ertapenem is used to prevent and treat a wide variety of bacterial infections. This medication is known as a carbapenem-type antibiotic. It works by stopping the growth of bacteria.

How is this Qilu Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67184055102. 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 (5-4-1)
67184-0551-2
11-Digit CMS (5-4-2)
67184-0551-02

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