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  5. NDC Package Code: 0944-2850-03 Cuvitru

NDC Package 0944-2850-03 Cuvitru

Immune Globulin Subcutaneous (human) Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. 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:
0944-2850-03
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-USE (0944-2850-04)
Product Code:
0944-2850
Proprietary Name:
Cuvitru
Non-Proprietary Name:
Immune Globulin Subcutaneous (human)
Substance Name:
Human Immunoglobulin G
Usage Information:
This medication is used to boost the body's natural defense system against infection in persons with a weakened immune system (primary immune deficiency). Immune globulin contains natural substances called antibodies (a type called IgG) that come from healthy human blood (plasma). These antibodies help protect your body against infections and help you to fight an infection if you get sick. Some immune globulin products may also be used to treat a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP).
11-Digit NDC Billing Format:
00944285003
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1809061 - immunoglobulin G, human 20 % in 50 ML Injection
  • RxCUI: 1809061 - 50 ML immunoglobulin G, human 200 MG/ML Injection
  • RxCUI: 1809061 - immunoglobulin G, human 10 GM per 50 ML Injection
  • RxCUI: 1809061 - immunoglobulin G, human 20 % per 50 ML Injection
  • RxCUI: 1809066 - immunoglobulin G, human 20 % in 20 ML Injection
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Takeda Pharmaceuticals America, Inc.
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • HUMAN IMMUNOGLOBULIN G 200 mg/mL
    • Pharmacologic Class(es):
  • Antigen Neutralization - [MoA] (Mechanism of Action)
  • Human Immunoglobulin G - [EPC] (Established Pharmacologic Class)
  • Immunoglobulins - [CS]
  • Passively Acquired Immunity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    BLA125596
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    10-18-2016
    Listing Expiration Date:
    12-31-2024
    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 0944-2850-03 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00944285003J1555Inj cuvitru, 100 mg100 MG112020

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0944-2850-011 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE (0944-2850-02)
    0944-2850-051 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE (0944-2850-06)
    0944-2850-071 VIAL, SINGLE-USE in 1 CARTON / 40 mL in 1 VIAL, SINGLE-USE (0944-2850-08)
    0944-2850-091 BOTTLE, GLASS in 1 CARTON / 50 mL in 1 BOTTLE, GLASS (0944-2850-10)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0944-2850-03?

    The NDC Packaged Code 0944-2850-03 is assigned to a package of 1 vial, single-use in 1 carton / 10 ml in 1 vial, single-use (0944-2850-04) of Cuvitru, a plasma derivative labeled by Takeda Pharmaceuticals America, Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 0944-2850 included in the NDC Directory?

    Yes, Cuvitru with product code 0944-2850 is active and included in the NDC Directory. The product was first marketed by Takeda Pharmaceuticals America, Inc. on October 18, 2016 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 NDC billing unit for package 0944-2850-03?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0944-2850-03?

    The 11-digit format is 00944285003. 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 4-4-2 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
    4-4-20944-2850-035-4-200944-2850-03