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  5. NDC Package Code: 80978-641-01 Ivra

NDC Package 80978-641-01 Ivra

Melphalan Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
80978-641-01
Package Description:
1 mL in 1 VIAL, MULTI-DOSE
Product Code:
80978-641
Proprietary Name:
Ivra
Non-Proprietary Name:
Melphalan
Substance Name:
Melphalan Hydrochloride
Usage Information:
This medication is used to treat certain types of cancer (such as multiple myeloma, ovarian). Melphalan belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.
11-Digit NDC Billing Format:
80978064101
NDC to RxNorm Crosswalk:
  • RxCUI: 2708998 - melphalan 90 MG/ML Injectable Solution
  • RxCUI: 2708998 - melphalan 90 MG (equivalent to melphalan hydrochloride 100.75 MG) per 1 ML Injectable Solution
  • RxCUI: 2709003 - IVRA 90 MG/ML Injectable Solution
  • RxCUI: 2709003 - melphalan 90 MG/ML Injectable Solution [Ivra]
  • RxCUI: 2709003 - Ivra 90 MG (equivalent to melphalan hydrochloride 100.75 MG) per 1 ML Injectable Solution
Product Type:
Human Prescription Drug
Labeler Name:
Aqvida Gmbh
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
MELPHALAN HYDROCHLORIDE 90 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA217110
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
03-19-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
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 80978-641-01?

The NDC Packaged Code 80978-641-01 is assigned to a package of 1 ml in 1 vial, multi-dose of Ivra, a human prescription drug labeled by Aqvida Gmbh. The product's dosage form is injection and is administered via intravenous form.

Is NDC 80978-641 included in the NDC Directory?

Yes, Ivra with product code 80978-641 is active and included in the NDC Directory. The product was first marketed by Aqvida Gmbh on March 19, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 80978-641-01?

The 11-digit format is 80978064101. 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
5-3-280978-641-015-4-280978-0641-01