Fosaprepitant Dimeglumine
NDC Package 0781-3484-75

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.

Fosaprepitant Dimeglumine is fosaprepitant is used with other medications to help prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). Marketed by Sandoz Inc, this product is identified by NDC 0781-3484 and is authorized under FDA application ANDA203939.

Identification & Billing

NDC Package Code
0781-3484-75
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE
Product Code
0781-3484
11-Digit Billing Format
00781348475

Clinical Specifications

Proprietary Name
Fosaprepitant Dimeglumine
Dosage Form
-
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
Sandoz Inc
FDA Application #
ANDA203939
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-16-2022
End Marketing Date
02-16-2022
Listing Expiration
02-16-2022
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 0781-3484-75 identifies a specific commercial package of 1 vial, single-use in 1 carton / 5 ml in 1 vial, single-use of Fosaprepitant Dimeglumine, labeled by Sandoz Inc. 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 Sandoz Inc on February 16, 2022. The current certification is valid through February 16, 2022.

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 Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781348475. 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 (4-4-2)
0781-3484-75
11-Digit CMS (5-4-2)
00781-3484-75

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