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  5. NDC Package Code: 57894-800-01 Imaavy

NDC Package 57894-800-01 Imaavy

Nipocalimab Injection, Solution, Concentrate Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
57894-800-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 BOX / 1.62 mL in 1 VIAL, SINGLE-DOSE
Product Code:
57894-800
Proprietary Name:
Imaavy
Non-Proprietary Name:
Nipocalimab
Substance Name:
Nipocalimab
Usage Information:
IMAAVY is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
11-Digit NDC Billing Format:
57894080001
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Janssen Biotech, Inc.
Dosage Form:
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route(s):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
NIPOCALIMAB 185 mg/mL
Sample Package:
No
FDA Application Number:
BLA761430
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
04-29-2025
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.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 57894-800-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
57894080001C9305Inj, nipocalimab-aahu, 3 mg3 MG1.621100100

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 57894-800-01?

The NDC Packaged Code 57894-800-01 is assigned to a package of 1 vial, single-dose in 1 box / 1.62 ml in 1 vial, single-dose of Imaavy, a human prescription drug labeled by Janssen Biotech, Inc.. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

Is NDC 57894-800 included in the NDC Directory?

Yes, Imaavy with product code 57894-800 is active and included in the NDC Directory. The product was first marketed by Janssen Biotech, Inc. on April 29, 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 57894-800-01?

The 11-digit format is 57894080001. 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
5-3-257894-800-015-4-257894-0800-01