Cutaquig Solution
NDC Package 0069-1802-02

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

Package Information

Cutaquig (immunoglobulin g) solution is cUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults. This formulation utilizes a solution delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0069-1802 and is authorized under FDA application BLA125668.

Identification & Billing

NDC Package Code
0069-1802-02
Package Description
1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS (0069-1802-01)
Product Code
0069-1802
11-Digit Billing Format
00069180202
RxNorm Crosswalk
  • RxCUI: 2167147 - immune globulin subcutaneous (human) - hipp 16.5 % (1 GM in 6 mL) Injection
  • RxCUI: 2167147 - 6 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection
  • RxCUI: 2167147 - 6 ML immune globulin subcutaneous (human) - hipp 16.5 % (1 GM per 6 ML) Injection
  • RxCUI: 2167152 - cutaquig 16.5 % (1 GM in 6 ML) Injection
  • RxCUI: 2167152 - 6 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]

Clinical Specifications

Proprietary Name
Cutaquig
Non-Proprietary Name
Immunoglobulin G
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
HUMAN IMMUNOGLOBULIN G 165 mg/mL
Pharmacologic Class
Usage Information
CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Regulatory & Marketing

Labeler Name
Pfizer Laboratories Div Pfizer Inc
Product Type
Plasma Derivative
FDA Application #
BLA125668
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-13-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0069-1802-02 identifies a specific commercial package of 1 vial, glass in 1 carton / 10 ml in 1 vial, glass (0069-1802-01) of Cutaquig, a plasma derivative labeled by Pfizer Laboratories Div Pfizer Inc. This solution is formulated for subcutaneous 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 September 13, 2019. 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: 00069180202. 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)
0069-1802-02
11-Digit CMS (5-4-2)
00069-1802-02

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