Ceftriaxone Sodium Injection, Powder, For Solution
NDC Package 67184-1007-1

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

Package Information

Ceftriaxone Sodium injection is ceftriaxone is used to treat a wide variety of bacterial infections. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Qilu Pharmaceutical Co., Ltd., this product is identified by NDC 67184-1007 and is authorized under FDA application ANDA203702.

Identification & Billing

NDC Package Code
67184-1007-1
Package Description
10 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE
Product Code
67184-1007
11-Digit Billing Format
67184100701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ceftriaxone Sodium
Non-Proprietary Name
Ceftriaxone Sodium
Substance Name
Ceftriaxone Sodium
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CEFTRIAXONE SODIUM 1 g/1
Pharmacologic Class
Usage Information
Ceftriaxone is used to treat a wide variety of bacterial infections. This medication belongs to a class of drugs known as cephalosporin antibiotics. It works by stopping the growth of bacteria. This drug is not recommended for use in newborns with high blood bilirubin levels and premature infants due to increased risk of side effects. Ask the doctor or pharmacist for details.

Regulatory & Marketing

Labeler Name
Qilu Pharmaceutical Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA203702
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-29-2016
Listing Expiration
12-31-2027
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 67184-1007-1 identifies a specific commercial package of 10 vial, single-use in 1 carton / 1 injection, powder, for solution in 1 vial, single-use of Ceftriaxone Sodium, a human prescription drug labeled by Qilu Pharmaceutical Co., Ltd.. This injection, powder, for solution is formulated for intramuscular; intravenous use and contains ceftriaxone 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 Qilu Pharmaceutical Co., Ltd. on June 29, 2016. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Ceftriaxone is used to treat a wide variety of bacterial infections. This medication belongs to a class of drugs known as cephalosporin antibiotics. It works by stopping the growth of bacteria. This drug is not recommended for use in newborns with high blood bilirubin levels and premature infants due to increased risk of side effects. Ask the doctor or pharmacist for details.

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: 67184100701. 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)
67184-1007-1
11-Digit CMS (5-4-2)
67184-1007-01

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