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  5. NDC Package Code: 69539-034-01 Fosaprepitant

NDC Package 69539-034-01 Fosaprepitant

View Billable Units, 11-Digit Format, RxNorm

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 inactivated by the FDA.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
69539-034-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code:
69539-034
Proprietary Name:
Fosaprepitant
Usage Information:
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: • acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. • delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).Limitations of Use • Fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting.Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
11-Digit NDC Billing Format:
69539003401
NDC to RxNorm Crosswalk:
Labeler Name:
Msn Laboratories Private Limited
Sample Package:
No
FDA Application Number:
ANDA209965
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
09-05-2019
Listing Expiration Date:
12-31-2024
Exclude Flag:
I
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 69539-034-01?

The NDC Packaged Code 69539-034-01 is assigned to a package of 1 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose of Fosaprepitant, labeled by Msn Laboratories Private Limited. The product's dosage form is and is administered via form.

Is NDC 69539-034 included in the NDC Directory?

No, Fosaprepitant with product code 69539-034 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Msn Laboratories Private Limited on September 05, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 69539-034-01?

The 11-digit format is 69539003401. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-269539-034-015-4-269539-0034-01