Octagam Immune Globulin (human) Solution
NDC Package 0069-6002-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Octagam Immune Globulin (human) (immune globulin) solution is octagam 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. This formulation utilizes a solution delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0069-6002 and is authorized under FDA application BLA125062.

Identification & Billing

NDC Package Code
0069-6002-02
Package Description
1 BOTTLE, GLASS in 1 CARTON / 20 mL in 1 BOTTLE, GLASS (0069-6002-01)
Product Code
0069-6002
11-Digit Billing Format
00069600202
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Octagam Immune Globulin (human)
Non-Proprietary Name
Immune Globulin
Substance Name
Human Immunoglobulin G
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
HUMAN IMMUNOGLOBULIN G 100 mg/mL
Pharmacologic Class
Usage Information
Octagam 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. Octagam 10% contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity .

Regulatory & Marketing

Labeler Name
Pfizer Laboratories Div Pfizer Inc
Product Type
Plasma Derivative
FDA Application #
BLA125062
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-13-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1568
Source: PDAC
INJECTION, IMMUNE GLOBULIN, (OCTAGAM), INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), 500 MG
HCPCS Dosage 500 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0069-6002-02 identifies a specific commercial package of 1 bottle, glass in 1 carton / 20 ml in 1 bottle, glass (0069-6002-01) of Octagam Immune Globulin (human), a plasma derivative labeled by Pfizer Laboratories Div Pfizer Inc. This solution is formulated for intravenous use and contains human immunoglobulin g as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Pfizer Laboratories Div Pfizer Inc on November 13, 2023. The current certification is valid through December 31, 2026.

How is this Pfizer Laboratories Div Pfizer Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00069600202. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0069-6002-02
11-Digit CMS (5-4-2)
00069-6002-02

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.