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  5. NDC Package Code: 0069-8425-02 Octagam Immune Globulin (human)

NDC Package 0069-8425-02 Octagam Immune Globulin (human)

Immune Globulin Solution 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:
0069-8425-02
Package Description:
1 BOTTLE, GLASS in 1 CARTON / 50 mL in 1 BOTTLE, GLASS (0069-8425-01)
Product Code:
0069-8425
Proprietary Name:
Octagam Immune Globulin (human)
Non-Proprietary Name:
Immune Globulin
Substance Name:
Human Immunoglobulin G
Usage Information:
Octagam 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin. in IgA deficient patients with antibodies against IgA and history of hypersensitivity. Octagam 5% liquid contains trace amounts of IgA (not more than 0.2 mg/mL in a 5% solution). (See Description [ 11 ]) in patients with acute hypersensitivity reaction to corn. Octagam 5% liquid contains maltose, a disaccharide sugar that is derived from corn. Patients known to have corn allergies should avoid using Octagam 5% liquid.
11-Digit NDC Billing Format:
00069842502
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1809447 - immunoglobulin G, human 5 % in 50 ML Injection
  • RxCUI: 1809447 - 50 ML immunoglobulin G, human 50 MG/ML Injection
  • RxCUI: 1809447 - immunoglobulin G, human 2.5 GM per 50 ML Injection
  • RxCUI: 1809447 - immunoglobulin G, human 5 % per 50 ML Injection
  • RxCUI: 1809456 - immunoglobulin G, human 5 % in 100 ML Injection
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Pfizer Laboratories Div Pfizer Inc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • HUMAN IMMUNOGLOBULIN G 50 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:
    BLA125062
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-13-2023
    Listing Expiration Date:
    12-31-2025
    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 0069-8425-02?

    The NDC Packaged Code 0069-8425-02 is assigned to a package of 1 bottle, glass in 1 carton / 50 ml in 1 bottle, glass (0069-8425-01) of Octagam Immune Globulin (human), a plasma derivative labeled by Pfizer Laboratories Div Pfizer Inc. The product's dosage form is solution and is administered via intravenous form.

    Is NDC 0069-8425 included in the NDC Directory?

    Yes, Octagam Immune Globulin (human) with product code 0069-8425 is active and included in the NDC Directory. The product was first marketed by Pfizer Laboratories Div Pfizer Inc on November 13, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0069-8425-02?

    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 0069-8425-02?

    The 11-digit format is 00069842502. 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
    4-4-20069-8425-025-4-200069-8425-02