Fosaprepitant Dimeglumine Injection, Powder, Lyophilized, For Solution
NDC Package 67184-0540-1

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

Package Information

Fosaprepitant Dimeglumine injection is fosaprepitant is used with other medications to help prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Qilu Pharmaceutical Co., Ltd., this product is identified by NDC 67184-0540 and is authorized under FDA application ANDA213106.

Identification & Billing

NDC Package Code
67184-0540-1
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code
67184-0540
11-Digit Billing Format
67184054001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fosaprepitant Dimeglumine
Non-Proprietary Name
Fosaprepitant Dimeglumine
Substance Name
Fosaprepitant Dimeglumine
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
FOSAPREPITANT DIMEGLUMINE 150 mg/5mL
Pharmacologic Class
Usage Information
Fosaprepitant is used with other medications to help prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). Fosaprepitant works by blocking one of the body's natural substances (substance P/neurokinin 1) that causes vomiting. This medication will not treat nausea or vomiting that has already started. Ask your doctor what you should do if you already have nausea or vomiting.

Regulatory & Marketing

Labeler Name
Qilu Pharmaceutical Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA213106
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-08-2020
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 67184-0540-1 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose of Fosaprepitant Dimeglumine, a human prescription drug labeled by Qilu Pharmaceutical Co., Ltd.. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains fosaprepitant dimeglumine 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 September 08, 2020. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Fosaprepitant is used with other medications to help prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). Fosaprepitant works by blocking one of the body's natural substances (substance P/neurokinin 1) that causes vomiting. This medication will not treat nausea or vomiting that has already started. Ask your doctor what you should do if you already have nausea or vomiting.

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: 67184054001. 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)
67184-0540-1
11-Digit CMS (5-4-2)
67184-0540-01

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